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1.  Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks' gestation (HYPITAT-II): a multicentre, open-label randomised controlled trial 
Background
Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the caesarean section rate. In view of this knowledge, one can raise the question whether women with severe hypertension, pre-eclampsia or deterioration chronic hypertension between 34 and 37 weeks of gestation should be delivered or monitored expectantly. Induction of labour might prevent maternal complications. However, induction of labour in late pre-term pregnancy might increase neonatal morbidity and mortality compared with delivery at term.
Methods/Design
Pregnant women with severe gestational hypertension, mild pre-eclampsia or deteriorating chronic hypertension at a gestational age between 34+0 and 36+6 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant monitoring. In the expectant monitoring arm, women will be induced only when the maternal or fetal condition detoriates or at 37+0 weeks of gestation. The primary outcome measure is a composite endpoint of maternal mortality, severe maternal complications (eclampsia, HELLP syndrome, pulmonary oedema and thromboembolic disease) and progression to severe pre-eclampsia. Secondary outcomes measures are respiratory distress syndrome (RDS), neonatal morbidity and mortality, caesarean section and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be intention to treat. The power calculation is based on an expectant reduction of the maternal composite endpoint from 5% to 1% for an expected increase in neonatal RDS from 1% at 37 weeks to 10% at 34 weeks. This implies that 680 women have to be randomised.
Discussion
This trial will provide insight as to whether in women with hypertensive disorders late pre-term, induction of labour is an effective treatment to prevent severe maternal complications without compromising the neonatal morbidity.
Trial Registration
NTR1792 Clinical trial registration: http://www.trialregister.nl
doi:10.1186/1471-2393-11-50
PMCID: PMC3161905  PMID: 21736705
2.  Should cervical favourability play a role in the decision for labour induction in gestational hypertension or mild pre-eclampsia at term? An exploratory analysis of the HYPITAT trial 
Bjog  2012;119(9):1123-1130.
Objective
To examine whether cervical favourability (measured by cervical length and the Bishop score) should inform obstetricians’ decision regarding labour induction for women with gestational hypertension or mild pre-eclampsia at term.
Design
A post hoc analysis of the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT).
Setting
Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands.
Population
A total of 756 women diagnosed with gestational hypertension or pre-eclampsia between 36 + 0 and 41 + 0 weeks of gestation randomly allocated to induction of labour or expectant management.
Methods
Data were analysed using logistic regression modelling.
Main outcome measures
The occurrence of a high-risk maternal situation defined as either maternal complications or progression to severe disease. Secondary outcomes were caesarean delivery and adverse neonatal outcomes.
Results
The superiority of labour induction in preventing high-risk situations in women with gestational hypertension or mild pre-eclampsia at term varied significantly according to cervical favourability. In women who were managed expectantly, the longer the cervix the higher the risk of developing maternal high-risk situations, whereas in women in whom labour was induced, cervical length was not associated with a higher probability of maternal high-risk situations (test of interaction P = 0.03). Similarly, the beneficial effect of labour induction on reducing the caesarean section rate was stronger in women with an unfavourable cervix.
Conclusion
Against widely held opinion, our exploratory analysis showed that women with gestational hypertension or mild pre-eclampsia at term who have an unfavourable cervix benefited more from labour induction than other women.
Trial registration
The trial has been registered in the clinical trial register as ISRCTN08132825.
doi:10.1111/j.1471-0528.2012.03405.x
PMCID: PMC3440582  PMID: 22703475
Bishop score; cervical length; expectant management; gestational hypertension; induction of labour; pre-eclampsia
3.  Uterine Rupture by Intended Mode of Delivery in the UK: A National Case-Control Study 
PLoS Medicine  2012;9(3):e1001184.
A case-control study using UK data estimates the risk of uterine rupture in subsequent deliveries amongst women who have had a previous caesarean section.
Background
Recent reports of the risk of morbidity due to uterine rupture are thought to have contributed in some countries to a decrease in the number of women attempting a vaginal birth after caesarean section. The aims of this study were to estimate the incidence of true uterine rupture in the UK and to investigate and quantify the associated risk factors and outcomes, on the basis of intended mode of delivery.
Methods and Findings
A UK national case-control study was undertaken between April 2009 and April 2010. The participants comprised 159 women with uterine rupture and 448 control women with a previous caesarean delivery. The estimated incidence of uterine rupture was 0.2 per 1,000 maternities overall; 2.1 and 0.3 per 1,000 maternities in women with a previous caesarean delivery planning vaginal or elective caesarean delivery, respectively. Amongst women with a previous caesarean delivery, odds of rupture were also increased in women who had ≥ two previous caesarean deliveries (adjusted odds ratio [aOR] 3.02, 95% CI 1.16–7.85) and <12 months since their last caesarean delivery (aOR 3.12, 95% CI 1.62–6.02). A higher risk of rupture with labour induction and oxytocin use was apparent (aOR 3.92, 95% CI 1.00–15.33). Two women with uterine rupture died (case fatality 1.3%, 95% CI 0.2–4.5%). There were 18 perinatal deaths associated with uterine rupture among 145 infants (perinatal mortality 124 per 1,000 total births, 95% CI 75–189).
Conclusions
Although uterine rupture is associated with significant mortality and morbidity, even amongst women with a previous caesarean section planning a vaginal delivery, it is a rare occurrence. For women with a previous caesarean section, risk of uterine rupture increases with number of previous caesarean deliveries, a short interval since the last caesarean section, and labour induction and/or augmentation. These factors should be considered when counselling and managing the labour of women with a previous caesarean section.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Uterine rupture is a serious complication of pregnancy in which the wall of the uterus (womb) tears during pregnancy or early labor. Signs and symptoms of uterine rupture include fetal heart rate abnormalities, abdominal pain, and vaginal bleeding. If uterine rupture happens during labor, the woman must have an immediate caesarean section (surgical delivery of her baby) to save both her life and that of her baby. The woman's womb and nearby organs can be damaged at rupture or removed during surgery and she may need a blood transfusion because of severe bleeding. Moreover, her baby may develop respiratory distress syndrome and other life-threatening complications. In high income countries, uterine rupture most commonly occurs in women who have delivered a previous pregnancy by caesarean section. In a caesarean section, the baby is delivered through a cut made through the abdominal wall and the uterine wall. The stretching that occurs during pregnancy or the strong contractions of labor can tear the scar left by this cut, resulting in uterine rupture.
Why Was This Study Done?
Women who have had a caesarean delivery are generally encouraged to try to deliver subsequent babies vaginally. However, recent reports of an increased risk of complications (morbidity) and death (mortality) due to uterine rupture are thought to reduce women's willingness to attempt vaginal birth after caesarean (VBAC) in some countries. In the UK, for example, where one in four babies is delivered by caesarean section, a previous caesarean delivery is one of commonest reasons for a repeat section. Obstetricians (doctors who care for women during child birth) need to know as much as possible about the incidence of uterine rupture and about the risk factors for it so that they can advise women who have had a previous caesarean section about their delivery options. In this national case-control study (a study that compares the characteristics of people with and without a specific condition), the researchers estimate the incidence of uterine rupture in the UK by intended mode of delivery and investigate and quantify the risk factors for and outcomes of uterine rupture.
What Did the Researchers Do and Find?
The researchers used the UK Obstetric Surveillance System (UKOSS) to identify all the women in the UK who had a uterine rupture over a 13-month period (159 women, 139 of whom had had a previous caesarean delivery). Controls for the study were women who had not had a uterine rupture but who had previously delivered by caesarean section. Overall, the incidence of uterine rupture was 0.2 per 1,000 maternities. In women with a previous caesarean delivery, 2.1 and 0.3 per 1,000 maternities ended in uterine rupture in women planning vaginal delivery and caesarean delivery, respectively. Amongst women who had had a previous caesarean delivery, the risk of uterine rupture was greater among those who had had two or more previous caesarean deliveries or a caesarean delivery less than 12 months previously, or whose labor was induced. Two women died following uterine rupture (a case fatality of 1.3%) and 18 babies died around the time of birth (a perinatal mortality rate of 124 per 1,000 live births; the UK perinatal mortality rate is 7.5 per 1,000 live births). 15 of the women who had a uterine rupture had their womb removed, 10 had other organs damaged, and nearly half had other complications; 19 of the surviving babies had health problems.
What Do These Findings Mean?
These findings indicate that, in the UK, although uterine rupture is associated with significant mortality and morbidity, it is a rare occurrence even among women who have had a previous caesarean delivery and are planning a vaginal delivery. They also indicate that, for women who have previously had a caesarean section, the risk of rupture increases with the number of previous caesarean deliveries, with a short interval since the last caesarean section, and with labor induction. Although the researchers may not have identified all the women who had a uterine rupture during the study period or may have identified only the worst cases, these findings provide valuable information about the factors that obstetricians need to consider when advising women who have previously had a caesarean section and when managing their labor.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001184.
This study is linked to a PLoS Medicine Research Article by Caroline Crowther and a PLoS Medicine Perspective by Catherine Spong
Wikipedia has a page on uterine rupture (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The American Congress of Obstetricians and Gynecologists has information sheets for patients on caesarean sections and on vaginal birth after caesarean delivery
The Royal College of Obstetricians and Gynaecologists in the UK has information for women on birth after previous caesarean
Childbirth Connection, a US-based not-for-profit organization, provides information about caesarean sections and about vaginal birth after caesarean
The National Childbirth Trust, a UK charity, provides information for parents on all aspects of pregnancy and birth, including caesarean sections and vaginal birth after caesarean delivery
The UK charity Healthtalkonline has personal stories from women making decisions about birth after a caesarean section
A personal story of uterine rupture during an attempted VBAC is available
The UK Obstetric Surveillance System studies rare disorders of pregnancy in the UK
doi:10.1371/journal.pmed.1001184
PMCID: PMC3302846  PMID: 22427745
4.  Effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week – 42 week dilemma 
Background
Post-term pregnancy, a pregnancy exceeding 294 days or 42 completed weeks, is associated with increased perinatal morbidity and mortality and is considered a high-risk condition which requires specialist surveillance and induction of labour. However, there is uncertainty on the policy concerning the timing of induction for post-term pregnancy or impending post-term pregnancy, leading to practice variation between caregivers. Previous studies on induction at or beyond 41 weeks versus expectant management showed different results on perinatal outcome though conclusions in meta-analyses show a preference for induction at 41 weeks. However, interpretation of the results is hampered by the limited sample size of most trials and the heterogeneity in design. Most control groups had a policy of awaiting spontaneous onset of labour that went far beyond 42 weeks, which does not reflect usual care in The Netherlands where induction of labour at 42 weeks is the regular policy. Thus leaving the question unanswered if induction at 41 weeks results in better perinatal outcomes than expectant management until 42 weeks.
Methods/design
In this study we compare a policy of labour induction at 41 + 0/+1 weeks with a policy of expectant management until 42 weeks in obstetrical low risk women without contra-indications for expectant management until 42 weeks and a singleton pregnancy in cephalic position. We will perform a multicenter randomised controlled clinical trial. Our primary outcome will be a composite outcome of perinatal mortality and neonatal morbidity. Secondary outcomes will be maternal outcomes as mode of delivery (operative vaginal delivery and Caesarean section), need for analgesia and postpartum haemorrhage (≥1000 ml). Maternal preferences, satisfaction, wellbeing, pain and anxiety will be assessed alongside the trial.
Discussion
This study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks.
Trial registration
Dutch Trial Register (Nederlands Trial Register): NTR3431. Registered: 14 May 2012.
doi:10.1186/1471-2393-14-350
PMCID: PMC4288619  PMID: 25338555
Pregnancy prolonged; Pregnancy post-term; Labour induced; Expectant management; Perinatal outcome, neonatal outcome; Maternal outcome; Maternal preferences
5.  Caesarean section versus vaginal delivery for preterm birth in singletons 
Background
Planned caesarean delivery for women thought be in preterm labour may be protective for baby, but could also be quite traumatic for both mother and baby. The optimal mode of delivery of preterm babies for both cephalic and breech presentation remains, therefore, controversial.
Objectives
To assess the effects of a policy of planned immediate caesarean delivery versus planned vaginal birth for women in preterm labour.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (24 April 2012).
Selection criteria
Randomised trials comparing a policy of planned immediate caesarean delivery versus planned vaginal delivery for preterm birth.
Data collection and analysis
Two review authors independently assessed trials for inclusion. Two review authors independently extracted data and assessed risk of bias. Data were checked for accuracy.
Main results
We included six studies (involving 122 women) but only four studies (involving only 116 women) contributed data to the analyses.
Infant
There were very little data of relevance to the three main (primary) outcomes considered in this review: There was no significant difference between planned immediate caesarean section and planned vaginal delivery with respect to birth injury to infant (risk ratio (RR) 0.56, 95%, confidence interval (CI) 0.05 to 5.62; one trial, 38 women) or birth asphyxia (RR 1.63, 95% CI 0.84 to 3.14; onetrial, 12 women). The only cases of birth trauma were a laceration of the buttock in a baby who was delivered by caesarean section and mild bruising in another allocated to the group delivered vaginally.
The difference between the two groups with regard to perinatal deaths was not significant (0.29, 95% CI 0.07 to 1.14; three trials, 89 women) and there were no data specifically relating to neonatal admission to special care and/or intensive care unit.
There was also no difference between the caesarean or vaginal delivery groups in terms of markers of possible birth asphyxia (RR 1.63, 95% CI 0.84 to 3.14; one trial, 12 women) or Apgar score less than seven at five minutes (RR 0.83, 95% CI 0.43 to 1.60; four trials, 115 women) and no difference in attempts at breastfeeding (RR 1.40, 95% 0.11 to 17.45; one trial, 12 women). There was also no difference in neonatal fitting/seizures (RR 0.22, 95% CI 0.01 to 4.32; three trials, 77 women), hypoxic ischaemic encephalopathy (RR 4.00, 95% CI 0.20 to 82.01;one trial, 12 women) or respiratory distress syndrome (RR 0.55, 95% CI 0.27 to 1.10; three trials, 103 women). There were no data reported in the trials specifically relating to meconium aspiration. There was also no significant difference between the two groups for abnormal follow-up in childhood (RR 0.65, 95% CI 0.19 to 2.22; one trial, 38 women) or delivery less than seven days after entry (RR 0.95, 95% CI 0.73 to 1.24; two trials, 51 women).
Mother
There were no data reported on maternal admissions to intensive care. However, there were seven cases of major maternal postpartum complications in the group allocated to planned immediate caesarean section and none in the group randomised to vaginal delivery (RR 7.21, 95% CI 1.37 to 38.08; four trials, 116 women).
There were no data reported in the trials specifically relating to maternal satisfaction (postnatal). There was no significant difference between the two groups with regard to postpartum haemorrhage. A number of non-prespecified secondary outcomes were also considered in the analyses. There was a significant advantage for women in the vaginal delivery group with respect to maternal puerperal pyrexia (RR 2.98, 95% CI 1.18 to 7.53; three trials, 89 women) and other maternal infection (RR 2.63, 95% CI 1.02 to 6.78; three trials, 103 women), but no significant differences in wound infection (RR 1.16, 95% CI 0.18 to 7.70; three trials, 103 women), maternal stay more than 10 days (RR 1.27, 95% CI 0.35 to 4.65; three trials, 78 women) or the need for blood transfusion (results not estimable).
Authors’ conclusions
There is not enough evidence to evaluate the use of a policy of planned immediate caesarean delivery for preterm babies. Further studies are needed in this area, but recruitment is proving difficult.
doi:10.1002/14651858.CD000078.pub2
PMCID: PMC4164504  PMID: 22696314
*Delivery, Obstetric; *Obstetric Labor, Premature; Birth Injuries [etiology]; Cesarean Section [adverse effects]; Infant, Newborn; Infant, Premature; Infant, Small for Gestational Age; Perinatal Mortality; Randomized Controlled Trials as Topic; Surgical Procedures, Elective; Female; Humans; Pregnancy
6.  A Risk Prediction Model for the Assessment and Triage of Women with Hypertensive Disorders of Pregnancy in Low-Resourced Settings: The miniPIERS (Pre-eclampsia Integrated Estimate of RiSk) Multi-country Prospective Cohort Study 
PLoS Medicine  2014;11(1):e1001589.
Beth Payne and colleagues use a risk prediction model, the Pre-eclampsia Integrated Estimate of RiSk (miniPIERS) to help inform the clinical assessment and triage of women with hypertensive disorders of pregnancy in low-resourced settings.
Please see later in the article for the Editors' Summary
Background
Pre-eclampsia/eclampsia are leading causes of maternal mortality and morbidity, particularly in low- and middle- income countries (LMICs). We developed the miniPIERS risk prediction model to provide a simple, evidence-based tool to identify pregnant women in LMICs at increased risk of death or major hypertensive-related complications.
Methods and Findings
From 1 July 2008 to 31 March 2012, in five LMICs, data were collected prospectively on 2,081 women with any hypertensive disorder of pregnancy admitted to a participating centre. Candidate predictors collected within 24 hours of admission were entered into a step-wise backward elimination logistic regression model to predict a composite adverse maternal outcome within 48 hours of admission. Model internal validation was accomplished by bootstrapping and external validation was completed using data from 1,300 women in the Pre-eclampsia Integrated Estimate of RiSk (fullPIERS) dataset. Predictive performance was assessed for calibration, discrimination, and stratification capacity. The final miniPIERS model included: parity (nulliparous versus multiparous); gestational age on admission; headache/visual disturbances; chest pain/dyspnoea; vaginal bleeding with abdominal pain; systolic blood pressure; and dipstick proteinuria. The miniPIERS model was well-calibrated and had an area under the receiver operating characteristic curve (AUC ROC) of 0.768 (95% CI 0.735–0.801) with an average optimism of 0.037. External validation AUC ROC was 0.713 (95% CI 0.658–0.768). A predicted probability ≥25% to define a positive test classified women with 85.5% accuracy. Limitations of this study include the composite outcome and the broad inclusion criteria of any hypertensive disorder of pregnancy. This broad approach was used to optimize model generalizability.
Conclusions
The miniPIERS model shows reasonable ability to identify women at increased risk of adverse maternal outcomes associated with the hypertensive disorders of pregnancy. It could be used in LMICs to identify women who would benefit most from interventions such as magnesium sulphate, antihypertensives, or transportation to a higher level of care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Each year, ten million women develop pre-eclampsia or a related hypertensive (high blood pressure) disorder of pregnancy and 76,000 women die as a result. Globally, hypertensive disorders of pregnancy cause around 12% of maternal deaths—deaths of women during or shortly after pregnancy. The mildest of these disorders is gestational hypertension, high blood pressure that develops after 20 weeks of pregnancy. Gestational hypertension does not usually harm the mother or her unborn child and resolves after delivery but up to a quarter of women with this condition develop pre-eclampsia, a combination of hypertension and protein in the urine (proteinuria). Women with mild pre-eclampsia may not have any symptoms—the condition is detected during antenatal checks—but more severe pre-eclampsia can cause headaches, blurred vision, and other symptoms, and can lead to eclampsia (fits), multiple organ failure, and death of the mother and/or her baby. The only “cure” for pre-eclampsia is to deliver the baby as soon as possible but women are sometimes given antihypertensive drugs to lower their blood pressure or magnesium sulfate to prevent seizures.
Why Was This Study Done?
Women in low- and middle-income countries (LMICs) are more likely to develop complications of pre-eclampsia than women in high-income countries and most of the deaths associated with hypertensive disorders of pregnancy occur in LMICs. The high burden of illness and death in LMICs is thought to be primarily due to delays in triage (the identification of women who are or may become severely ill and who need specialist care) and delays in transporting these women to facilities where they can receive appropriate care. Because there is a shortage of health care workers who are adequately trained in the triage of suspected cases of hypertensive disorders of pregnancy in many LMICs, one way to improve the situation might be to design a simple tool to identify women at increased risk of complications or death from hypertensive disorders of pregnancy. Here, the researchers develop miniPIERS (Pre-eclampsia Integrated Estimate of RiSk), a clinical risk prediction model for adverse outcomes among women with hypertensive disorders of pregnancy suitable for use in community and primary health care facilities in LMICs.
What Did the Researchers Do and Find?
The researchers used data on candidate predictors of outcome that are easy to collect and/or measure in all health care settings and that are associated with pre-eclampsia from women admitted with any hypertensive disorder of pregnancy to participating centers in five LMICs to build a model to predict death or a serious complication such as organ damage within 48 hours of admission. The miniPIERS model included parity (whether the woman had been pregnant before), gestational age (length of pregnancy), headache/visual disturbances, chest pain/shortness of breath, vaginal bleeding with abdominal pain, systolic blood pressure, and proteinuria detected using a dipstick. The model was well-calibrated (the predicted risk of adverse outcomes agreed with the observed risk of adverse outcomes among the study participants), it had a good discriminatory ability (it could separate women who had a an adverse outcome from those who did not), and it designated women as being at high risk (25% or greater probability of an adverse outcome) with an accuracy of 85.5%. Importantly, external validation using data collected in fullPIERS, a study that developed a more complex clinical prediction model based on data from women attending tertiary hospitals in high-income countries, confirmed the predictive performance of miniPIERS.
What Do These Findings Mean?
These findings indicate that the miniPIERS model performs reasonably well as a tool to identify women at increased risk of adverse maternal outcomes associated with hypertensive disorders of pregnancy. Because miniPIERS only includes simple-to-measure personal characteristics, symptoms, and signs, it could potentially be used in resource-constrained settings to identify the women who would benefit most from interventions such as transportation to a higher level of care. However, further external validation of miniPIERS is needed using data collected from women living in LMICs before the model can be used during routine antenatal care. Moreover, the value of miniPIERS needs to be confirmed in implementation projects that examine whether its potential translates into clinical improvements. For now, though, the model could provide the basis for an education program to increase the knowledge of women, families, and community health care workers in LMICs about the signs and symptoms of hypertensive disorders of pregnancy.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001589.
The World Health Organization provides guidelines for the management of hypertensive disorders of pregnancy in low-resourced settings
The Maternal and Child Health Integrated Program provides information on pre-eclampsia and eclampsia targeted to low-resourced settings along with a tool-kit for LMIC providers
The US National Heart, Lung, and Blood Institute provides information about high blood pressure in pregnancy and a guide to lowering blood pressure in pregnancy
The UK National Health Service Choices website provides information about pre-eclampsia
The US not-for profit organization Preeclampsia Foundation provides information about all aspects of pre-eclampsia; its website includes some personal stories
The UK charity Healthtalkonline also provides personal stories about hypertensive disorders of pregnancy
MedlinePlus provides links to further information about high blood pressure and pregnancy (in English and Spanish); the MedlinePlus Encyclopedia has a video about pre-eclampsia (also in English and Spanish)
More information about miniPIERS and about fullPIERS is available
doi:10.1371/journal.pmed.1001589
PMCID: PMC3897359  PMID: 24465185
7.  The Effect of Changing Patterns of Obstetric Care in Scotland (1980–2004) on Rates of Preterm Birth and Its Neonatal Consequences: Perinatal Database Study 
PLoS Medicine  2009;6(9):e1000153.
Jane Norman and colleagues analyzed linked perinatal surveillance data in Scotland and find that between 1980 and 2004 increases in spontaneous and medically induced preterm births contributed equally to the rising rate of preterm births.
Background
Rates of preterm birth are rising worldwide. Studies from the United States and Latin America suggest that much of this rise relates to increased rates of medically indicated preterm birth. In contrast, European and Australian data suggest that increases in spontaneous preterm labour also play a role. We aimed, in a population-based database of 5 million people, to determine the temporal trends and obstetric antecedents of singleton preterm birth and its associated neonatal mortality and morbidity for the period 1980–2004.
Methods and Findings
There were 1.49 million births in Scotland over the study period, of which 5.8% were preterm. We found a percentage increase in crude rates of both spontaneous preterm birth per 1,000 singleton births (10.7%, p<0.01) and medically indicated preterm births (41.2%, p<0.01), which persisted when adjusted for maternal age at delivery. The greater proportion of spontaneous preterm births meant that the absolute increase in rates of preterm birth in each category were similar. Of specific maternal complications, essential and pregnancy-induced hypertension, pre-eclampsia, and placenta praevia played a decreasing role in preterm birth over the study period, with gestational and pre-existing diabetes playing an increasing role. There was a decline in stillbirth, neonatal, and extended perinatal mortality associated with preterm birth at all gestation over the study period but an increase in the rate of prolonged hospital stay for the neonate. Neonatal mortality improved in all subgroups, regardless of obstetric antecedent of preterm birth or gestational age. In the 28 wk and greater gestational groups we found a reduction in stillbirths and extended perinatal mortality for medically induced but not spontaneous preterm births (in the absence of maternal complications) although at the expense of a longer stay in neonatal intensive care. This improvement in stillbirth and neonatal mortality supports the decision making behind the 34% increase in elective/induced preterm birth in these women. Although improvements in neonatal outcomes overall are welcome, preterm birth still accounts for over 66% of singleton stillbirths, 65% of singleton neonatal deaths, and 67% of infants whose stay in the neonatal unit is “prolonged,” suggesting this condition remains a significant contributor to perinatal mortality and morbidity.
Conclusions
In our population, increases in spontaneous and medically induced preterm births have made equal contributions to the rising rate of preterm birth. Despite improvements in related perinatal mortality, preterm birth remains a major obstetric and neonatal problem, and its frequency is increasing.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Most pregnancies last about 40 weeks but increasing numbers of babies are being born preterm, before they reach 37 weeks of gestation (gestation is the period during which a baby develops in its mother). Nowadays in the US, for example, more than half a million babies arrive earlier than expected every year (1 in 8 babies). Although improvements in the care of newborn babies (neonatal care) mean that preterm babies are more likely to survive than in the past, preterm birth remains the single biggest cause of infant death in many developed countries, and many preterm babies who survive have long-term health problems and disabilities, particularly those born before 32 weeks of gestation. Preterm births can be spontaneous or medically induced. At present, it impossible to predict which mothers will spontaneously deliver early and there is no effective way to prevent these preterm births; medically induced early labor is undertaken when either the unborn baby or mother would be at risk if the pregnancy continued to full term.
Why Was This Study Done?
Preterm birth rates need to be reduced, but before this can be done it is important to know how the causes of preterm birth, the numbers of preterm stillbirths, and the numbers of preterm babies who die at birth (neonatal deaths) or soon after (perinatal deaths) are changing with time. If, for example, the rise in preterm births is mainly due to an increase in medically induced labor and if this change in practice has reduced neonatal deaths, it would be unwise to try to reduce the preterm birth rate by discouraging medically induced preterm births. So far, data from the US and Latin America suggest that the increase in preterm births in these countries is solely due to increased rates of medically induced preterm births. However, in Europe and Australia, the rate of spontaneous preterm births also seems to be increasing. In this study, the researchers examine the trends over time and causes of preterm birth and of neonatal death and illness in Scotland over a 25-year period.
What Did the Researchers Do and Find?
By searching a Scottish database of linked maternity records and infant health and death records, the researchers identified 1.49 million singleton births that occurred between 1980 and 2004 of which nearly 90,000 were preterm births. Over the study period, the rates of spontaneous and of medically induced preterm births per 1,000 births increased by 10.7% and 41.2%, respectively, but because there were more spontaneous preterm births than medically induced preterm births, the absolute increase in the rates of each type of birth was similar. Several maternal complications including preeclampsia (a condition that causes high blood pressure) and placenta previa (covering of the opening of the cervix by the placenta) played a decreasing role in preterm births over the study period, whereas gestational and preexisting diabetes played an increasing role. Finally, there was a decline in stillbirths and in neonatal and perinatal deaths among preterm babies, although more babies remained in the hospital longer than 7 days after birth. More specifically, after 28 weeks of gestation, stillbirths and perinatal deaths decreased among medically induced preterm births but not among spontaneous preterm births.
What Do These Findings Mean?
These findings indicate that in Scotland between 1980 and 2004, increases in spontaneous and medically induced preterm births contributed equally to the rising rate of preterm births. Importantly, they also show that the increase in induced preterm births helped to reduce stillbirths and neonatal and perinatal deaths, a finding that supports the criteria that clinicians currently use to decide whether to induce an early birth. Nevertheless, preterm births still account for two-thirds of all stillbirths, neonatal deaths, and extended neonatal stays in hospital and thus cause considerable suffering and greatly increase the workload in neonatal units. The rates of such births consequently need to be reduced and, for Scotland at least, ways will have to be found to reduce the rates of both spontaneous and induced preterm births to achieve this goal while continuing to identify those sick babies who need to be delivered early to give them the best chance of survival.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000153
Tommys is a nonprofit organization that funds research and provides information on the causes and prevention of miscarriage, premature birth, and stillbirth
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on preterm birth (in English and Spanish)
The Nemours Foundation, another nonprofit organization for child health, also provides information on premature babies (in English and Spanish)
The US Centers for Disease Control and Prevention provides information on maternal and infant health (in English and Spanish)
The US National Women's Health Information Center has detailed information about pregnancy, including a section on pregnancy complications
MedlinePlus provides links to other information on premature babies and to information on pregnancy (in English and Spanish)
doi:10.1371/journal.pmed.1000153
PMCID: PMC2740823  PMID: 19771156
8.  Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT) 
Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term.
Design Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)).
Setting Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008.
Participants Pregnant women who had a singleton pregnancy beyond 36+0 weeks’ gestation with suspected intrauterine growth restriction.
Interventions Induction of labour or expectant monitoring.
Main outcome measures The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means.
Results 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference −9.9 days, 95% CI −11.3 to −8.6) and weighed 130 g less (mean difference −130 g, 95% CI −188 g to −71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference −0.8%, 95% CI −4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI −5.0% to 5.6%).
Conclusions In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth.
Trial registration International Standard Randomised Controlled Trial number ISRCTN10363217.
doi:10.1136/bmj.c7087
PMCID: PMC3005565  PMID: 21177352
9.  Induction of labour for improving birth outcomes for women at or beyond term 
Background
As a pregnancy continues beyond term the risks of babies dying inside the womb or in the immediate newborn period increase. Whether a policy of labour induction at a predetermined gestational age can reduce this increased risk is the subject of this review.
Objectives
To evaluate the benefits and harms of a policy of labour induction at term or post-term compared with awaiting spontaneous labour or later induction of labour.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 March 2012).
Selection criteria
Randomised controlled trials conducted in women at or beyond term. The eligible trials were those comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour. Cluster-randomised trials and cross-over trials are not included. Quasi-random allocation schemes such as alternation, case record numbers or open random-number lists were not eligible.
Data collection and analysis
Two review authors independently assessed trials for inclusion. Two review authors independently assessed trial quality and extracted data. Data were checked for accuracy. Outcomes are analysed in two main categories: gestational age and cervix status.
Main results
We included 22 trials reporting on 9383 women. The trials were generally at moderate risk of bias.
Compared with a policy of expectant management, a policy of labour induction was associated with fewer (all-cause) perinatal deaths: risk ratio (RR) 0.31, 95% confidence interval (CI) 0.12 to 0.88; 17 trials, 7407 women. There was one perinatal death in the labour induction policy group compared with 13 perinatal deaths in the expectant management group. The number needed to treat to benefit (NNTB) with induction of labour in order to prevent one perinatal death was 410 (95% CI 322 to 1492).
For the primary outcome of perinatal death and most other outcomes, no differences between timing of induction subgroups were seen; the majority of trials adopted a policy of induction at 41 completed weeks (287 days) or more.
Fewer babies in the labour induction group had meconium aspiration syndrome (RR 0.50, 95% CI 0.34 to 0.73; eight trials, 2371 infants) compared with a policy of expectant management. There was no statistically significant difference between the rates of neonatal intensive care unit (NICU) admission for induction compared with expectant management (RR 0.90, 95% CI 0.78 to 1.04; 10 trials, 6161 infants). For women in the policy of induction arms of trials, there were significantly fewer caesarean sections compared with expectant management in 21 trials of 8749 women (RR 0.89, 95% CI 0.81 to 0.97).
Authors’ conclusions
A policy of labour induction compared with expectant management is associated with fewer perinatal deaths and fewer caesarean sections. Some infant morbidities such as meconium aspiration syndrome were also reduced with a policy of post-term labour induction although no significant differences in the rate of NICU admission were seen.
However, the absolute risk of perinatal death is small. Women should be appropriately counselled in order to make an informed choice between scheduled induction for a post-term pregnancy or monitoring without induction (or delayed induction).
doi:10.1002/14651858.CD004945.pub3
PMCID: PMC4065650  PMID: 22696345
* Pregnancy, Prolonged; *Watchful Waiting; Cesarean Section [utilization]; Infant Mortality; Infant, Newborn; Labor, Induced [*adverse effects]; Randomized Controlled Trials as Topic; Risk; Female; Humans; Pregnancy
10.  "GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies" 
Background
Gestational Diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.
Methods/Design
Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the Outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurement4s are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.
Discussion
The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms.
Trial Registration
The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT01058772.
doi:10.1186/1471-2393-11-31
PMCID: PMC3108319  PMID: 21507262
11.  Immersion in water in labour and birth 
Background
Enthusiasts suggest that labouring in water and waterbirth increase maternal relaxation, reduce analgesia requirements and promote a midwifery model of care. Critics cite the risk of neonatal water inhalation and maternal/neonatal infection.
Objectives
To assess the evidence from randomised controlled trials about immersion in water during labour and waterbirth on maternal, fetal, neonatal and caregiver outcomes.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 June 2011) and reference lists of retrieved studies.
Selection criteria
Randomised controlled trials comparing immersion in any bath tub/pool with no immersion, or other non-pharmacological forms of pain management during labour and/or birth, in women during labour who were considered to be at low risk of complications, as defined by the researchers.
Data collection and analysis
We assessed trial eligibility and quality and extracted data independently. One review author entered data and the other checked for accuracy.
Main results
This review includes 12 trials (3243 women): eight related to just the first stage of labour: one to early versus late immersion in the first stage of labour; two to the first and second stages; and another to the second stage only. We identified no trials evaluating different baths/pools, or the management of third stage of labour.
Results for the first stage of labour showed there was a significant reduction in the epidural/spinal/paracervical analgesia/anaesthesia rate amongst women allocated to water immersion compared to controls (478/1254 versus 529/1245; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.82 to 0.99, six trials). There was also a reduction in duration of the first stage of labour (mean difference −32.4 minutes; 95% CI −58.7 to −6.13). There was no difference in assisted vaginal deliveries (RR 0.86; 95% CI 0.71 to 1.05, seven trials), caesarean sections (RR 1.21; 95% CI 0.87 to 1.68, eight trials), use of oxytocin infusion (RR 0.64; 95%CI 0.32 to 1.28,five trials), perineal trauma or maternal infection. There were no differences for Apgar score less than seven at five minutes (RR 1.58; 95% CI 0.63 to 3.93, five trials), neonatal unit admissions (RR 1.06; 95% CI 0.71 to 1.57, three trials), or neonatal infection rates (RR 2.00; 95% CI 0.50 to 7.94, five trials).
Of the three trials that compared water immersion during the second stage with no immersion, one trial showed a significantly higher level of satisfaction with the birth experience (RR 0.24; 95% CI 0.07 to 0.80).
A lack of data for some comparisons prevented robust conclusions. Further research is needed.
Authors’ conclusions
Evidence suggests that water immersion during the first stage of labour reduces the use of epidural/spinal analgesia and duration of the first stage of labour. There is limited information for other outcomes related to water use during the first and second stages of labour, due to intervention and outcome variability. There is no evidence of increased adverse effects to the fetus/neonate or woman from labouring in water or waterbirth. However, the studies are very variable and considerable heterogeneity was detected for some outcomes. Further research is needed.
doi:10.1002/14651858.CD000111.pub3
PMCID: PMC3982045  PMID: 19370552
12.  Caesarean section for non-medical reasons at term 
Background
Caesarean section rates are progressively rising in many parts of the world. One suggested reason is increasing requests by women for caesarean section in the absence of clear medical indications, such as placenta praevia, HIV infection, contracted pelvis and, arguably, breech presentation or previous caesarean section. The reported benefits of planned caesarean section include greater safety for the baby, less pelvic floor trauma for the mother, avoidance of labour pain and convenience. The potential disadvantages, from observational studies, include increased risk of major morbidity or mortality for the mother, adverse psychological sequelae, and problems in subsequent pregnancies, including uterine scar rupture and a greater risk of stillbirth and neonatal morbidity. The differences in neonatal physiology following vaginal and caesarean births are thought to have implications for the infant, with caesarean section potentially increasing the risk of compromised health in both the short and the long term. An unbiased assessment of advantages and disadvantages would assist discussion of what has become a contentious issue in modern obstetrics.
Objectives
To assess, from randomised trials, the effects on perinatal and maternal morbidity and mortality, and on maternal psychological morbidity, of planned caesarean delivery versus planned vaginal birth in women with no clear clinical indication for caesarean section.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 January 2012) and reference lists of relevant studies.
Selection criteria
All comparisons of intention to perform caesarean section and intention for women to give birth vaginally; random allocation to treatment and control groups; adequate allocation concealment; women at term with single fetuses with cephalic presentations and no clear medical indication for caesarean section.
Data collection and analysis
We identified no studies that met the inclusion criteria.
Main results
There were no included trials.
Authors’ conclusions
There is no evidence from randomised controlled trials, upon which to base any practice recommendations regarding planned caesarean section for non-medical reasons at term. In the absence of trial data, there is an urgent need for a systematic review of observational studies and a synthesis of qualitative data to better assess the short- and long-term effects of caesarean section and vaginal birth.
doi:10.1002/14651858.CD004660.pub3
PMCID: PMC4171389  PMID: 22419296
*Cesarean Section [adverse effects; psychology]; *Term Birth; Female; Humans; Pregnancy
13.  Different methods for the induction of labour in outpatient settings 
Background
Induction of labour is carried out for a variety of indications and using a range of pharmacological, mechanical and other methods. For women at low risk, some methods of induction of labour may be suitable for use in outpatient settings.
Objectives
To examine pharmacological and mechanical interventions to induce labour in outpatient settings in terms of feasibility, effectiveness, maternal satisfaction, healthcare costs and, where information is available, safety. The review complements existing reviews on labour induction examining effectiveness and safety.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (December 2009) and reference lists of retrieved studies.
Selection criteria
We included randomised controlled trials examining outpatient cervical ripening or induction of labour with pharmacological agents or mechanical methods.
Data collection and analysis
Two authors independently extracted data and assessed eligible papers for risk of bias. We checked all data after entry into review manager software.
Main results
We included 28 studies with 2616 women examining different methods of induction of labour where women received treatment at home or were sent home after initial treatment and monitoring in hospital.
Studies examined vaginal and intracervical PGE2, vaginal and oral misoprostol, isosorbide mononitrate, mifepristone, oestrogens, and acupuncture. Overall, the results demonstrate that outpatient induction of labour is feasible and that important adverse events are rare. There was no strong evidence that agents used to induce labour in outpatient settings had an impact (positive or negative) on maternal or neonatal health. There was some evidence that, compared to placebo or no treatment, induction agents reduced the need for further interventions to induce labour, and shortened the interval from intervention to birth. We were unable to pool results on outcomes relating to progress in labour as studies tended to measure a very broad range of outcomes.
There was no evidence that induction agents increased interventions in labour such as operative deliveries. Only two studies provided information on women’s views about the induction process, and overall there was very little information on the costs to health service providers of different methods of labour induction in outpatient settings.
Authors’ conclusions
Induction of labour in outpatient settings appears feasible. We do not have sufficient evidence to know which induction methods are preferred by women, or the interventions that are most effective and safe to use in outpatient settings.
doi:10.1002/14651858.CD007701.pub2
PMCID: PMC4241469  PMID: 20687092
* Ambulatory Care; Acupuncture Therapy [methods]; Feasibility Studies; Labor, Induced [* methods]; Oxytocics; Randomized Controlled Trials as Topic; Female; Humans; Pregnancy
14.  Outpatient versus inpatient induction of labour for improving birth outcomes 
Background
More than 20% of women undergo induction of labour in some countries. The different methods used to induce labour have been the focus of previous reviews, but the setting in which induction takes place (hospital versus outpatient settings) may have implications for maternal satisfaction and costs. It is not known whether some methods of induction that are effective and safe in hospital are suitable in outpatient settings.
Objectives
To assess the effects on outcomes for mothers and babies of induction of labour for women managed as outpatients versus inpatients.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (December 2008). We updated this search on 24 February 2012 and added the results to the awaiting classification section.
Selection criteria
Published and unpublished randomised and quasi-randomised trials in which inpatient and outpatient methods of cervical ripening or induction of labour have been compared.
Data collection and analysis
Two review authors independently assessed trial reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently.
Main results
We included three trials, with a combined total of 612 women in the review; each examined a different method of induction and we were unable to pool the results from trials. Vaginal PGE2 (One study including 201 women). There were no differences between women managed as out- versus inpatients for most review outcomes. Women in the outpatient group were more likely to have instrumental deliveries (risk ratio (RR) 1.74; 95% confidence interval (CI) 1.03 to 2.93). The overall length of hospital stay was similar in the two groups.Controlled release PGE2 10mg (one study including 300 women). There was no evidence of differences between groups for most review outcomes, including success of induction. During the induction period itself, women in the outpatient group were more likely to report high levels of satisfaction with their care (satisfaction rated seven or more on a nine-point scale RR 1.42; 95% CI 1.11 to 1.81), but satisfaction scores measured postnatally were similar in the two groups.Foley catheter (one study including 111 women). There was no evidence of differences between groups for caesarean section rates, total induction time and the numbers of babies admitted to neonatal intensive care.
Authors’ conclusions
The data available to evaluate the efficacy or potential hazards of outpatient induction are limited. It is, therefore, not yet possible to determine whether induction of labour is effective and safe in outpatient settings.
[Note: The four citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]
doi:10.1002/14651858.CD007372.pub2
PMCID: PMC4127418  PMID: 19370687
*Cervical Ripening; *Hospitalization; Ambulatory Care [*methods]; Catheterization; Dinoprostone; Infant, Newborn; Labor, Induced [*methods]; Length of Stay; Oxytocics; Patient Satisfaction; Pregnancy Outcome; Randomized Controlled Trials as Topic; Female; Humans; Pregnancy
15.  Effect of partogram use on outcomes for women in spontaneous labour at term 
Background
The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women’s labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.
Objectives
To determine the effect of use of partogram on perinatal and maternal morbidity and mortality.
To determine the effect of partogram design on perinatal and maternal morbidity and mortality.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 May 2012).
Selection criteria
Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs.
Data collection and analysis
Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining authors assessed the studies independently.
Main results
We have included six studies involving 7706 women in this review; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and four-hour action line groups were compared, caesarean section rate was lowest in the four-hour action line group and this difference was statistically significant (RR 1.70, 95% CI 1.07 to 2.70, n = 613, one trial). When a partogram with a latent phase (composite) and one without (modified) were compared, the caesarean section rate was lower in the partograph without a latent phase (RR 2.45, 95% CI 1.72 to 3.50, n = 743, one trial).
Authors’ conclusions
On the basis of the findings of this review, we cannot recommend routine use of the partogram as part of standard labour management and care. Given the fact that the partogram is currently in widespread use and generally accepted, it appears reasonable, until stronger evidence is available, that partogram use should be locally determined. Further trial evidence is required to establish the efficacy of partogram use.
doi:10.1002/14651858.CD005461.pub3
PMCID: PMC4161496  PMID: 22895950
*Pregnancy Outcome; Cesarean Section [utilization]; Delivery, Obstetric [methods]; Labor, Obstetric [* physiology]; Randomized Controlled Trials as Topic; Term Birth [* physiology]; Uterine Inertia [diagnosis]; Uterine Monitoring [* methods]; Female; Humans; Pregnancy
16.  Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT 
Background
Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.
Methods/design
The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.
Discussion
This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.
Trial registration
Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
doi:10.1186/1471-2393-7-12
PMCID: PMC1933438  PMID: 17623077
17.  Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial 
PLoS Medicine  2012;9(3):e1001192.
A study conducted in Australia provides new data on the outcomes for mother and baby associated with either planned vaginal birth, or elective repeat caesarean section following a previous caesarean section.
Background
Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC.
Methods and findings
2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled.
The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19–0.80; number needed to treat to benefit 66; 95% CI 40–200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17–0.80).
Conclusions
Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean.
Trial registration
Current Controlled Trials ISRCTN53974531
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Rates of caesarean section are rising around the world, particularly in high- and middle-income countries, where most women have a choice of how their baby is delivered. Historically, the obstetrician in charge of the woman's care made the decision on whether to perform an elective (planned) caesarean section based on medical criteria. For women who have had a previous caesarean section, typically, their options for mode of childbirth are either a trial of vaginal birth or an elective repeat caesarean section. The proportion of women attempting a vaginal birth after a previous caesarean section has been declining in many countries partly due to the variable chance of achieving a successful vaginal birth (reported between 56% and 80%) and partly because of negative reports of the risk of complications, both to the mother and the baby, of a having a vaginal delivery following a caesarean section. Consequently, the rates of repeat caesarean section have risen sharply, for example, currently 83% in Australia and almost 90% in the US.
Why Was This Study Done?
Both elective repeat caesarean section and subsequent vaginal delivery after a previous caesarean section have clinical risks and benefits. Most obviously, having a surgical procedure puts the woman having the repeat caesarean section at risk of surgical complications, especially if performed under a general anesthetic, and her baby may be at risk of respiratory complications. However, subsequent vaginal delivery following a previous caesarean section may put the mother at risk of bleeding severely enough to need a blood transfusion (more than 1,500 ml blood loss) and she may also be at increased risk of rupturing her uterus; and her baby may have an increased risk of dying or of becoming brain damaged due to lack of oxygen.
However, to date there have been no randomized controlled trials of elective repeat caesarean section versus vaginal delivery following a previous caesarean section to compare the health outcomes of mother and baby and a recent systematic review could draw no conclusions. So the researchers conducted this prospective cohort study based on patient preference (with a few women agreeing to be randomized to mode of delivery), to compare the health outcomes for mother and baby for elective repeat caesarean section versus vaginal delivery in women following a previous caesarean section.
What Did the Researchers Do and Find?
Between 2002 and 2007, the researchers recruited 2,345 suitable women (that is, women who had one previous caesarean section, were currently 37 weeks pregnant with a single baby, and who were clinically able to have a vaginal delivery) from 14 maternity hospitals throughout Australia. A few women (22) agreed to be randomized to either mode of delivery but most women chose her preferred option. Then, depending on the woman's preferences for mode of birth, participating obstetricians either scheduled a date for an elective caesarean section (1,098 women) or assessed on-going suitability for the woman to have a planned vaginal delivery (1,225 women). However only 535 (43.2%) women who chose to have a vaginal birth were able to deliver this way because of failure to progress in labor or fetal distress: 334 of these women (27.0%) had to have an elective caesarean section and 368 women had to have an emergency caesarean section.
Although no women died, women who had a planned caesarean section experienced less severe bleeding than women who delivered vaginally. There were no infant deaths in those born by elective caesarean section but two unexplained stillbirths in the planned vaginal delivery group. There was also a reduced risk of nonfatal serious outcome before discharge from hospital for infants delivered by in the elective caesarean section. The researchers calculated that one infant death or near death would be prevented for every 66 elective caesarean sections performed in women who had a previous caesarean section.
What Do These Findings Mean?
These findings show that in women who had delivered by a previous caesarean section delivering their next baby by planned caesarean section was associated with less infant death and better health outcomes for the mother before she was discharged from the hospital compared to women who had a subsequent vaginal delivery. This information can be used by women, clinicians, and policy makers in helping to make decisions about the mode of subsequent deliveries and best care for women who have had a previous caesarean section.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001192.
This study is linked to a PLoS Medicine Research Article by Fitzpatrick and colleagues and a PLoS Medicine Perspective by Catherine Spong
The American Congress of Obstetricians and Gynecologists has information sheets for patients on caesarean sections and on vaginal birth after caesarean delivery
Childbirth Connection, a US-based not-for-profit organization, provides information about caesarean sections and about vaginal birth after caesarean
The National Childbirth Trust, a UK charity, provides information for parents on all aspects of pregnancy and birth, including caesarean sections and vaginal birth after caesarean delivery
The UK charity Healthtalkonline has personal stories from women making decisions about birth after a caesarean section
doi:10.1371/journal.pmed.1001192
PMCID: PMC3302845  PMID: 22427749
18.  Outcomes of elective induction of labour compared with expectant management: population based study 
Objective To determine neonatal outcomes (perinatal mortality and special care unit admission) and maternal outcomes (mode of delivery, delivery complications) of elective induction of labour compared with expectant management.
Design Retrospective cohort study using an unselected population database.
Setting Consultant and midwife led obstetric units in Scotland 1981-2007.
Participants 1 271 549 women with singleton pregnancies of 37 weeks or more gestation.
Interventions Outcomes of elective induction of labour (induction of labour with no recognised medical indication) at 37, 38, 39, 40, and 41 weeks’ gestation compared with those of expectant management (continuation of pregnancy to either spontaneous labour, induction of labour or caesarean section at a later gestation).
Main outcome measures Extended perinatal mortality, mode of delivery, postpartum haemorrhage, obstetric anal sphincter injury, and admission to a neonatal or special care baby unit. Outcomes were adjusted for age at delivery, parity, year of birth, birth weight, deprivation category, and, where appropriate, mode of delivery.
Results At each gestation between 37 and 41 completed weeks, elective induction of labour was associated with a decreased odds of perinatal mortality compared with expectant management (at 40 weeks’ gestation 0.08% (37/44 764) in the induction of labour group versus 0.18% (627/350 643) in the expectant management group; adjusted odds ratio 0.39, 99% confidence interval 0.24 to 0.63), without a reduction in the odds of spontaneous vertex delivery (at 40 weeks’ gestation 79.9% (35 775/44 778) in the induction of labour group versus 73.7% (258 665/350 791) in the expectant management group; adjusted odds ratio 1.26, 1.22 to 1.31). Admission to a neonatal unit was, however, increased in association with elective induction of labour at all gestations before 41 weeks (at 40 weeks’ gestation 8.0% (3605/44 778) in the induction of labour group compared with 7.3% (25 572/350 791) in the expectant management group; adjusted odds ratio 1.14, 1.09 to 1.20).
Conclusion Although residual confounding may remain, our findings indicate that elective induction of labour at term gestation can reduce perinatal mortality in developed countries without increasing the risk of operative delivery.
doi:10.1136/bmj.e2838
PMCID: PMC3349781  PMID: 22577197
19.  Package of care for active management in labour for reducing caesarean section rates in low-risk women 
Background
Approximately 15% of women have caesarean sections (CS) and while the rate varies, the number is increasing in many countries. This is of concern because higher CS rates do not confer additional health gain but may adversely affect maternal health and have implications for future pregnancies. Active management of labour has been proposed as a means of reducing CS rates. This refers to a package of care including strict diagnosis of labour, routine amniotomy, oxytocin for slow progress and one to one support in labour.
Objectives
To determine whether active management of labour reduces CS rates in low-risk women and improves satisfaction.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (February 2008), MEDLINE (1966 to December 2007), EMBASE (1980 to 2007), MIDIRS (1985 to 2007) and CINAHL (1982 to 2007).
Selection criteria
Randomised controlled trials comparing low-risk women receiving a predefined package of care (active management) with women receiving routine (variable) care. Trials where slow progress had been diagnosed before entry into the trial were excluded.
Data collection and analysis
At least two review authors extracted data. We assessed included studies for risk of bias.
Main results
We included seven trials, with a total of 5390 women. The quality of studies was mixed. The CS rate was slightly lower in the active management group compared to the group that received routine care, but this difference did not reach statistical significance (RR 0.88, 95% CI 0.77 to 1.01). However, in one study there was a large number of post-randomisation exclusions. On excluding this study, CS rates in the active management group were statistically significantly lower than in the routine care group (RR 0.77 95% CI 0.63 to 0.94). More women in the active management group had labours lasting less than twelve hours, but there was wide variation in length of labour within and between trials. There were no differences between groups in use of analgesia, rates of assisted vaginal deliveries or maternal or neonatal complications. Only one trial examined maternal satisfaction; the majority of women (over 75%) in both groups were very satisfied with care.
Authors’ conclusions
Active management is associated with small reductions in the CS rate, but it is highly prescriptive and interventional. It is possible that some components of the active management package are more effective than others. Further work is required to determine the acceptability of active management to women in labour.
doi:10.1002/14651858.CD004907.pub2
PMCID: PMC4161199  PMID: 18843671
*Labor, Obstetric; Cesarean Section [trends; *utilization]; Labor, Induced [*methods]; Oxytocics; Oxytocin; Randomized Controlled Trials as Topic; Female; Humans; Pregnancy
20.  Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial 
Background
Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness.
Methods/Design
We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women’s preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome.
Discussion
Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines.
Trial registration
The Netherlands Trial Register NTR3466
doi:10.1186/1471-2393-13-67
PMCID: PMC3610263  PMID: 23506128
Induction of labour; Oral misoprostol; Foley catheter; Asphyxia; Post partum haemorrhage; Hyperstimulation; Bishop score; Unfavourable cervix
21.  Pre-pregnancy Body Mass Index (BMI) and delivery outcomes in a Canadian population 
Background
Worldwide there has been a dramatic increase in the prevalence of overweight and obesity in women of childbearing age. Growing evidence suggests that maternal overweight and obesity is associated with poor maternal and perinatal outcomes. This study evaluated the impact of maternal pre-pregnancy overweight and obesity on pregnancy, labour and delivery outcomes in a cohort of women with term, singleton pregnancies cared for by family physicians in community based practices.
Methods
This study is a secondary analysis of the All Our Babies Cohort, a prospective, community-based pregnancy cohort in Calgary, Alberta. Maternal self-reported data on height and pre-pregnancy weight from term, singleton, cephalic pregnancies (n = 1996) were linked to clinical data on pregnancy and birth events retrieved from electronic health records. Descriptive and bivariate regression analysis were used to compare pregnancy and birth outcomes between women categorized as normal weight, overweight and obese based on the pre-pregnancy BMI. Multinomial regression analysis stratified by type of labour onset examined the association between pre-pregnancy BMI and mode of delivery controlling for maternal age, pre-existent health conditions, parity, fertility treatments, history of C-section and pregnancy complications.
Results
The cohort consisted of 65.8% normal weight, 23.6% overweight and 10.6% obese women. Women with increased pre-pregnancy BMI were more likely to develop pregnancy complications such as preeclampsia (OR 3.5, CI 2.0-4.6 for overweight; OR 5.3, CI 3.3-8.5 for obese) and gestational diabetes (OR 3.0, CI 1.8-5.0 for overweight; OR 6.5, CI 3.7-11.2 for obese) than normal weight women. Spontaneous onset of labour was recorded in 71.2% of women with normal pre-pregnancy BMI, whereas 39.3% of overweight and 49% of obese women had their labour induced. For women with spontaneous labour, pre-pregnancy BMI was not a significant risk factor for mode of delivery, controlling for covariates. Among women with induced labor, obesity was a significant risk factor for delivery by C-section (adjusted OR 2.2; CI 1.2-4.1).
Conclusions
Even among women with term, singleton pregnancies obtaining prenatal care in community-based settings, obese women who undergo labour induction are at increased risk of obstetrical interventions at delivery. These findings highlight the importance of tailored maternal care in pregnancy and at delivery of pregnant women with increased BMI in order to improve the outcomes and wellbeing of these women and their children.
Electronic supplementary material
The online version of this article (doi:10.1186/s12884-014-0422-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s12884-014-0422-y
PMCID: PMC4300169  PMID: 25528667
Pregnancy; Obesity; Overweight; Labour induction; Caesarean section; Pregnancy complications
22.  10-Year cardiovascular event risks for women who experienced hypertensive disorders in late pregnancy: the HyRAS study 
Background
Cardiovascular disease is the cause of death in 32% of women in the Netherlands. Prediction of an individual's risk for cardiovascular disease is difficult, in particular in younger women due to low sensitive and specific tests for these women. 10% to 15% of all pregnancies are complicated by hypertensive disorders, the vast majority of which develop only after 36 weeks of gestation. Preeclampsia and cardiovascular disease in later life show both features of "the metabolic syndrome" and atherosclerosis. Hypertensive disorders in pregnancy and cardiovascular disease may develop by common pathophysiologic pathways initiated by similar vascular risk factors. Vascular damage occurring during preeclampsia or gestational hypertension may contribute to the development of future cardiovascular disease, or is already present before pregnancy. At present clinicians do not systematically aim at the possible cardiovascular consequences in later life after a hypertensive pregnancy disorder at term. However, screening for risk factors after preeclampsia or gestational hypertension at term may give insight into an individual's cardiovascular risk profile.
Methods/Design
Women with a history of preeclampsia or gestational hypertension will be invited to participate in a cohort study 2 1/2 years after delivery. Participants will be screened for established modifiable cardiovascular risk indicators. The primary outcome is the 10-year cardiovascular event risk. Secondary outcomes include differences in cardiovascular parameters, SNP's in glucose metabolism, and neonatal outcome.
Discussion
This study will provide evidence on the potential health gains of a modifiable cardiovascular risk factor screening program for women whose pregnancy was complicated by hypertension or preeclampsia. The calculation of individual 10-year cardiovascular event risks will allow identification of those women who will benefit from primary prevention by tailored interventions, at a relatively young age.
Trial registration
The HYPITAT trial is registered in the clinical trial register as ISRCTN08132825.
doi:10.1186/1471-2393-10-28
PMCID: PMC2889848  PMID: 20515501
23.  Timing of birth for women with a twin pregnancy at term: a randomised controlled trial 
Background
There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time.
The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications.
Methods/Design
Design: Multicentred randomised trial.
Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy.
Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care.
Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible).
Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity.
Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power).
Discussion
This is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation.
Clinical Trial Registration
Current Controlled Trials ISRCTN15761056
doi:10.1186/1471-2393-10-68
PMCID: PMC2978123  PMID: 20973989
24.  Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial 
Objectives To test whether ursodeoxycholic acid reduces pruritus in women with intrahepatic cholestasis of pregnancy, whether early term delivery does not increase the incidence of caesarean section, and the feasibility of recruiting women with intrahepatic cholestasis of pregnancy to trials of these interventions.
Design First phase of a semifactorial randomised controlled trial.
Setting Nine consultant led maternity units, United Kingdom.
Participants 125 women with intrahepatic cholestasis of pregnancy (pruritus and raised levels of serum bile acids) or pruritus and raised alanine transaminase levels (>100 IU/L) recruited after 24 weeks’ gestation and followed until delivery. 56 women were randomised to ursodeoxycholic acid, 55 to placebo, 30 to early term delivery, and 32 to expectant management.
Interventions Ursodeoxycholic acid 500 mg twice daily or placebo increased as necessary for symptomatic or biochemical improvement until delivery; early term delivery (induction or delivery started between 37+0 and 37+6) or expectant management (spontaneous labour awaited until 40 weeks’ gestation or caesarean section undertaken by normal obstetric guidelines, usually after 39 weeks’ gestation).
Main outcome measures The primary outcome for ursodeoxycholic acid was maternal itch (arithmetic mean of measures (100 mm visual analogue scale) of worst itch in past 24 hours) and for the timing of delivery was caesarean section. Secondary outcomes were other maternal and perinatal outcomes and recruitment rates.
Results Ursodeoxycholic acid reduced itching by −16 mm (95% confidence interval −27 mm to −6 mm), less than the 30 mm difference prespecified by clinicians and women as clinically meaningful. 32% (14/44) of women randomised to ursodeoxycholic acid experienced a reduction in worst itching by at least 30 mm compared with 16% (6/37) randomised to placebo. The difference of 16% (95% confidence interval −3 to 34); this would represent a number needed to treat of 6, but it failed to reach significance. Early term delivery did not increase caesarean sections (7/30 (23%) in the early term delivery group versus 11/32 (33%) in the expectant management group (relative risk 0.70, 95% confidence interval 0.31 to 1.57). No serious harms were noted in either trial. 22% (73/325) of eligible women participated in the drug trial and 19% (39/209) in the timing of delivery trial; both groups had a similar spectrum of disease severity to non-participants.
Conclusions Ursodeoxycholic acid significantly reduces pruritus, but the size of the benefit may be too small for most doctors to recommend it, or for most women to want to take it. Women are, however, likely to differ in whether they consider the benefit to be worthwhile. Planned early term delivery seems not to increase incidence of caesarean section, although a small increase cannot be excluded. A trial to test whether ursodeoxycholic acid reduces adverse perinatal outcomes would have to be large, but is feasible. A trial to test the effect of early term delivery on adverse fetal outcomes would have to be significantly larger and may not be feasible.
Trial registration Current Controlled Trials ISRCTN37730443.
doi:10.1136/bmj.e3799
PMCID: PMC3420230  PMID: 22695903
25.  Rate of spontaneous onset of labour before planned repeat caesarean section at term 
Background
Guidelines recommend that, in the absence of compelling medical indications (low risk) elective caesarean section should occur after 38 completed weeks gestation. However, implementation of these guidelines will mean some women go into labour before the planned date resulting in an intrapartum caesarean section. The aim of this study was to determine the rate at which low-risk women planned for repeat caesarean section go into spontaneous labour before 39 weeks.
Methods
We conducted a population-based cohort study of women who were planned to have an elective repeat caesarean section (ERCS) at 39-41 weeks gestation in New South Wales Australia, 2007-2010. Labour, delivery and health outcome information was obtained from linked birth and hospital records for the entire population. Women with no pre-existing medical or pregnancy complications were categorized as ‘low risk’. The rate of spontaneous labour before 39 weeks was determined and variation in the rate for subgroups of women was examined using univariate and multivariate analysis.
Results
Of 32,934 women who had ERCS as the reported indication for caesarean section, 17,314 (52.6%) were categorised as ‘low-risk’. Of these women, 1,473 (8.5% or 1 in 12) had spontaneous labour or prelabour rupture of the membranes before 39 weeks resulting in an intrapartum caesarean section. However the risk of labour <39 weeks varied depending on previous delivery history: 25% (1 in 4) for those with spontaneous preterm labour in a prior pregnancy; 15% (1 in 7) for women with a prior planned preterm birth (by labour induction or prelabour caesarean) and 6% (1 in 17) among those who had only previously had a planned caesarean section at term. Smoking in pregnancy was also associated with spontaneous labour. Women with spontaneous labour prior to a planned CS in the index pregnancy were at increased risk of out-of-hours delivery, and maternal and neonatal morbidity.
Conclusions
These findings allow clinicians to more accurately determine the likelihood that a planned caesarean section may become an intrapartum caesarean section, and to advise their patients accordingly.
doi:10.1186/1471-2393-14-125
PMCID: PMC3975468  PMID: 24694261
Cohort study; Elective repeat caesarean section; Labour; Record linkage

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