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1.  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
2.  Postoperative outcome of caesarean sections and other major emergency obstetric surgery by clinical officers and medical officers in Malawi 
Background
Clinical officers perform much of major emergency surgery in Malawi, in the absence of medical officers. The aim of this study was to validate the advantages and disadvantages of delegation of major obstetric surgery to non-doctors.
Methods
During a three month period, data from 2131 consecutive obstetric surgeries in 38 district hospitals in Malawi were collected prospectively. The interventions included caesarean sections alone and those that were combined with other interventions such as subtotal and total hysterectomy repair of uterine rupture and tubal ligation. All these surgeries were conducted either by clinical officers or by medical officers.
Results
During the study period, clinical officers performed 90% of all straight caesarean sections, 70% of those combined with subtotal hysterectomy, 60% of those combined with total hysterectomy and 89% of those combined with repair of uterine rupture. A comparable profile of patients was operated on by clinical officers and medical officers, respectively. Postoperative outcomes were almost identical in the two groups in terms of maternal general condition – both immediately and 24 hours postoperatively – and regarding occurrence of pyrexia, wound infection, wound dehiscence, need for re-operation, neonatal outcome or maternal death.
Conclusion
Clinical officers perform the bulk of emergency obstetric operations at district hospitals in Malawi. The postoperative outcomes of their procedures are comparable to those of medical officers. Clinical officers constitute a crucial component of the health care team in Malawi for saving maternal and neonatal lives given the scarcity of physicians.
doi:10.1186/1478-4491-5-17
PMCID: PMC1920531  PMID: 17570847
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.  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
5.  Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section 
Background
Nausea and vomiting are distressing symptoms which are experienced commonly during caesarean section under regional anaesthesia and can also occur in the period following the procedure.
Objectives
To assess the efficacy of pharmacological and non-pharmacological interventions given prophylactically to prevent nausea and vomiting in women undergoing regional anaesthesia for caesarean section.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (27 February 2012) and reference lists of identified studies.
Selection criteria
We included randomised controlled trials (RCTs) and excluded quasi-RCTs and cross-over studies.
Data collection and analysis
Review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data entry was checked.
Main results
Fifty-two studies met the inclusion criteria but only 41 studies, involving 5046 women, provided useable data for the review involving women having caesareans under regional anaesthesia. The majority of the studies involved women undergoing elective caesarean section. Only two studies included emergency surgery, however, they did not stratify data according to type of surgery. The studies covered numerous comparisons, but the majority of studies involved 5-HT3 receptor antagonists, dopamine receptor antagonists, corticosteroids or acupressure. Studies were mainly small and of unclear quality.
Three classes of intervention were found to be effective in at least three out of four of our primary outcomes (intraoperative nausea, intraoperative vomiting, postoperative nausea and postoperative vomiting). These interventions were 5-HT3 antagonists, dopamine antagonists and sedatives. Other classes of intervention were effective for fewer than three of our primary outcomes.
With 5-HT antagonists, we found a reduction in intraoperative nausea (average risk ratio (RR) 0.64, 95% confidence interval (CI) 0.46 to 0.88, eight studies, 720 women). There were also reductions in postoperative nausea (average RR 0.40, 95% CI 0.25 to 0.64, four studies, 405 women) and vomiting (average RR 0.50, 95% CI 0.32 to 0.77, five studies, 565 women). We did not detect a significant reduction in intraoperative vomiting (average RR 0.56, 95% CI 0.31 to 1.00, seven studies, 668 women).
Dopamine antagonists demonstrated a reduction in intraoperative nausea (average RR 0.38, 95% CI 0.25 to 0.57, nine studies, 636 women) and intraoperative vomiting (average 0.39, 95% CI 0.24 to 0.64, eight studies, 536 women), with similar reductions in postoperative nausea (average RR 0.60, 95% CI 0.40 to 0.91, five studies, 412 women) and vomiting (average RR 0.57, 95% CI 0.36 to 0.91, six studies, 472 women). These differences were observed with both metoclopramide and droperidol.
Sedatives (most commonly propofol) demonstrated a reduction in intraoperative nausea (average RR 0.71, 95% CI 0.52 to 0.96, four studies, 285 women) and intraoperative vomiting (average RR 0.42, 95% CI 0.26 to 0.68, four studies, 285 women), also with a reduction in postoperative nausea (average RR 0.25, 95% CI 0.09 to 0.71, two studies 145 women) and vomiting (average RR 0.09, 95% CI 0.03 to 0.28, two studies, 145 women).
Acupressure was found to be effective for intraoperative nausea (average RR 0.59, 95% CI 0.38 to 0.90, six studies, 649 women) but not postoperative nausea (average RR 0.83, 95% CI 0.68 to 1.00, three studies, 429 women). Acupressure was not effective at reducing vomiting either intraoperatively (average RR 0.74, 95% CI 0.46 to 1.18, six studies, 649 women) or postoperatively (average RR 0.69, 95% CI 0.45 to 1.06, three studies, 429 women).
Other effective intervention classes included corticosteroids, antihistamines, and anticholinergics.
There were insufficient data to demonstrate any class of intervention was superior to another. There were no significant differences observed in the comparison of combined versus single interventions.
Few studies assessed our secondary outcomes or the incidence of adverse effects. However, one study showed an increase in respiratory depression with sedation (midazolam) compared with dopamine antagonists.
Authors’ conclusions
This review indicates that many different interventions have efficacy in preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. There is little evidence that combinations of treatment are better than single agents.
doi:10.1002/14651858.CD007579.pub2
PMCID: PMC4204618  PMID: 22972112
Acupressure; Adrenal Cortex Hormones [therapeutic use]; Anesthesia, Conduction [*adverse effects]; Cesarean Section [*adverse effects]; Dopamine Antagonists [therapeutic use]; Hypnotics and Sedatives [therapeutic use]; Intraoperative Complications [prevention & control]; Nausea [*prevention & control]; Postoperative Nausea and Vomiting [prevention & control]; Pregnancy Complications [*prevention & control]; Randomized Controlled Trials as Topic; Serotonin Antagonists [therapeutic use]; Vomiting [*prevention & control]; Female; Humans; Pregnancy
6.  Interventions at caesarean section for reducing the risk of aspiration pneumonitis 
Background
Aspiration pneumonitis is a syndrome resulting from the inhalation of gastric contents. The incidence in obstetric anaesthesia has fallen, largely due to improved anaesthetic techniques and the increased use of regional anaesthesia at caesarean section. However, aspiration pneumonitis is still a cause of maternal morbidity and mortality, and it is important to use effective prophylaxis.
Objectives
To determine whether interventions given prior to caesarean section reduce the risk of aspiration pneumonitis in women with an uncomplicated pregnancy.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (April 2009).
Selection criteria
Randomised controlled trials were included. Quasi-randomised trials were excluded.
Data collection and analysis
Authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data entry was checked.
Main results
Twenty-two studies, involving 2658 women, are included, all having a caesarean section under general anaesthesia. The studies covered a number of comparisons, but were mostly small and of unclear or poor quality.
When compared to no treatment or placebo, there was a significant reduction in the risk of intragastric pH < 2.5 with antacids (risk ratio (RR) 0.17, 95% confidence interval (CI) 0.09 to 0.32, two studies, 108 women), H2 antagonists (RR 0.09, 95% CI 0.05 to 0.18, two studies, 170 women) and proton pump antagonists (RR 0.26, 95% CI 0.14 to 0.46, one study 80 women). H2 antagonists were associated with a reduced the risk of intragastric pH < 2.5 at intubation when compared with proton pump antagonists (RR 0.39, 95% CI 0.16 to 0.97, one study, 120 women), but compared with antacids the findings were unclear. The combined use of ’antacids plus H2 antagonists’ was associated with a significant reduction in the risk of intragastric pH < 2.5 at intubation when compared with placebo (RR 0.02, 95% CI 0.00 to 0.15, one study, 89 women) or compared with antacids alone (RR 0.12, 95% CI 0.02 to 0.92, one study, 119 women).
Authors’ conclusions
The quality of the evidence was poor, but the findings suggest that the combination of antacids plus H2 antagonists was more effective than no intervention, and superior to antacids alone in preventing low gastric pH. However, none of the studies assessed potential adverse effects or substantive clinical outcomes. These findings are relevant for all women undergoing caesarean section under general anaesthesia.
doi:10.1002/14651858.CD004943.pub3
PMCID: PMC4063196  PMID: 20091567
*Cesarean Section; Anesthesia, General [adverse effects]; Anesthesia, Obstetrical [adverse effects]; Antacids [therapeutic use]; Antiemetics [therapeutic use]; Drug Therapy, Combination [methods]; Histamine H2 Antagonists [therapeutic use]; Metoclopramide [therapeutic use]; Pneumonia, Aspiration [*prevention & control]; Proton Pump Inhibitors [therapeutic use]; Randomized Controlled Trials as Topic; Female; Humans; Pregnancy
7.  A Five-year Survey of Caesarean Delivery at a Nigerian Tertiary Hospital 
Background:
The rising global rate in caesarean delivery has been a source of concern to obstetricians worldwide. In spite of remarkable improvement in the safety of anaesthesia and surgical techniques, caesarean section has higher risks of maternal death when compared with normal vaginal delivery. Thus, the current emphasis is to limit the rising rate of caesarean section to as much as possible.
Objective:
To determine the rate of caesarean section, pregnancy out-come, major indications and complications of caesarean section.
Methods:
A five year (January 1st 2005 to December 31st 2009) retrospective analysis of clinical data from the ward admissions and discharge books, patients’ folders and the operating theatre record books at the University of Nigeria Teaching Hospital, Ituku Ozalla, Enugu.
Results:
Out of the 3,554 deliveries during the study period, 980 cases were by caesarean section, giving a rate of 27.6%. Most cases 918 (93.7%) were by emergency caesarean sections, with elective procedure accounting only for 6.3% of the cases. The age range of the women was between 16-48yrs. Four hundred and seven (41.5%) were primigravidae, 503(51.4%) were between para one and para four, while 70 (7.1%) were grand-multipara. The rate of caesarean section was higher amongst the booked patients, 563 (57.5%) than the unbooked patients 355 (36.2%). Two previous caesarean section was the commonest indication for caesarean section 211(21.5%), followed by cephalopelvic disproportion 198 (20.2%), and foetal distress188 (19.2%). A total of 1009 babies were delivered through caesarean section by the 980 women; 955 cases of singleton gestations and 25 cases of multiple gestations (21 twins and 4 triplets). Majority of the babies 918 (91%) were delivered by emergency procedure. More than half of the babies 582(57.7%) had birth asphyxia and there were 39 (3.9%) perinatal deaths. All the cases of perinatal deaths and 549 (94.3%) of birth asphyxia were following emergency procedure. Anaemia was the commonest postpartum morbidity and the maternal case fatality rate was 0.7%.
Conclusion:
There is now a further rise in rate of caesarean section after a slight drop that followed the initial high 1.5fold rise from previous studies. The perinatal outcome is poor especially following emergency caesarean section. Reducing primary caesarean section rate and more encouragement of vaginal delivery after one previous caesarean section may reduce the prevalence of two previous caesarean sections which is the leading indication for caesarean section in the hospital.
PMCID: PMC3507098  PMID: 23209958
Caesarean section; survey; tertiary hospital: Nigeria
8.  Tissue Adhesives for Simple Traumatic Lacerations 
Journal of Athletic Training  2008;43(2):222-224.
Reference/Citation: Farion K, Osmond MH, Hartling L, et al. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2001(4);CD003326.
Clinical Question: What is the clinical evidence base for tissue adhesives in the management of simple traumatic lacerations?
Data Sources: Studies were identified by searches of the following databases: Cochrane Wounds Group Specialized Trials Register (September 2003), Cochrane Central Register of Controlled Trials (CENTRAL) (CDROM 2003, issue 3), MEDLINE (1966 to September 2003, week 1), EMBASE (1988 to 2003, week 36), Web of Science Science Citation Index (1975 to September 13, 2003) and various clinical trials registers (September 2003). Investigators and product manufacturers were contacted to identify additional eligible studies. The search terms included wounds and injuries, laceration, face injury, nose injury, tissue adhesives, and acrylates.
Study Selection: Each study fulfilled the following criteria: (1) The study was a randomized controlled trial that compared tissue adhesives with standard wound closure (SWC) (sutures, staples, adhesive strips) or tissue adhesive with tissue adhesive. (2) The wounds were acute, linear lacerations less than 12 hours old, resulting from blunt or sharp trauma. (3) The wound length, width, and depth allowed for approximation of the edges with minimal tension after deep sutures were placed, if required. Studies were included with no language or publication status restriction, with participants of any age recruited in an emergency department, outpatient clinic, walk-in clinic, or other primary care setting. Studies were excluded if the wounds were stellate lacerations, puncture wounds, mammalian bites, infected, heavily contaminated or devitalized, crossing joints or mucocutaneous junctions, in hair-bearing areas, or in patients with keloid formation or chronic illness.
Data Extraction: The characteristics of the study and participants, interventions, outcome measures, and findings were extracted by one author and verified by a second using a standard form. The primary measure was cosmetic outcome. Secondary measures were pain with the procedure, time to complete the procedure, and complications (erythema, infection, discharge, need for delayed closure, and dehiscence). Studies were divided into 2 groups as follows: group 1, comparisons among tissue adhesives with SWC, and group 2, comparisons among different tissue adhesives. All eligible studies were assessed for methodologic quality independently by 2 investigators using the Jadad Scale, which evaluates randomization, double blinding, withdrawals, and dropouts and is scored on a 5-point (maximum) scale. The data from the tissue adhesive and SWC studies were pooled and analyzed with a random-effects model. The I 2 statistic was used to determine heterogeneity among the studies. χ 2 analysis was performed to compare participant age, wound location, and type of tissue adhesive among the studies. The data from the studies comparing tissue adhesives were pooled and analyzed using a fixed-effects model.
Main Results: The search criteria identified 39 eligible studies, of which 11 met the inclusion criteria. In 10 studies, a tissue adhesive was compared with SWC. Five groups used butylcyanoacrylate, and 5 used octylcyanoacrylate. For SWC, 6 groups used sutures, 2 used adhesive strips, and 2 used a combination of methods, although most used sutures. Six studies were limited to pediatric patients and 2 to adult patients; 2 included patients of any age. Wounds were limited to facial lacerations in 2 pediatric studies and 1 group with patients of any age. Lacerations requiring deep sutures were excluded in 4 studies. One group compared tissue adhesives (butylcyanoacrylate and octylcyanoacrylate) among pediatric patients with facial lacerations not requiring deep sutures. In the 11 included studies, authors of 9 randomized and evaluated 1 laceration per patient, whereas 2 groups included patients with more than 1 laceration. In 1 group, each laceration was independently randomized and evaluated, and the other group randomized the patient and assigned all lacerations to a treatment group (tissue adhesive with SWC or tissue adhesive with tissue adhesive). The sample sizes ranged between 60 and 163 lacerations, and all 11 studies were performed in emergency departments.
The primary measure in all included studies was cosmetic outcome. The majority of groups used the Cosmetic Visual Analogue Scale, the Wound Evaluation Score, or a combination of these measures. Three groups measured cosmetic outcome with nonvalidated scoring systems. Assessment time periods were grouped and reported at (1) 5 to 14 days, (2) 1 to 3 months, and (3) 9 to 12 months after wound closure. Secondary outcomes were pain (as noted on visual analogue scale) and time to complete the procedure (as mean number of minutes). The 11 studies scored from 1 to 3 on the Jadad Scale. Adequate allocation concealment was reported in only 1 group.
Examining cosmetic outcome, 8 groups (565 lacerations) used the Cosmetic Visual Analogue Scale to compare tissue adhesives and SWC. The authors reported no significant differences in scores at the time periods of 5 to 14 days, 1 to 3 months, and 9 to 12 months. A subgroup analysis showed a significant ( P = .005) superiority of butylcyanoacrylate over SWC at 1 to 3 months. Using the Wound Evaluation Score, 4 studies (364 lacerations) compared tissue adhesives with SWC. No significant differences in cosmetic scores were found at 5 to 14 days, 1 to 3 months, or 9 to 12 months. One group (83 lacerations) compared butylcyanoacrylate with octylcyanoacrylate and reported no significant differences in cosmetic scores using the Cosmetic Visual Analogue Scale at 1 to 3 months and the Wound Evaluation Score at 5 to 14 days and 1 to 3 months.
Examining secondary outcomes, 6 groups (570 lacerations) compared tissue adhesives with SWC using the visual analogue scale for pain. Scores reported by parents, patients, physicians, and nurses significantly favored tissue adhesives. In 6 studies (584 lacerations), tissue adhesives were significantly favored over SWC in time to complete the procedure. For complication outcomes, 8 groups (727 lacerations) demonstrated significantly fewer incidences of erythema and an increased risk of dehiscence with tissue adhesives compared with SWC. No significant differences were shown for infection, delayed closure, or discharge. Among 83 lacerations, 1 group compared butylcyanoacrylate with octylcyanoacrylate and reported no significant differences in combined patient-reported and parent-reported visual analogue pain scores, time to complete the procedure, dehiscence, or infection.
Conclusions: This review provides evidence that tissue adhesives are an option to SWC (sutures, staples, adhesive strips) for the management of simple traumatic lacerations. Overall, no significant differences were found in cosmetic scores at the reported assessment periods between tissue adhesives and SWC. At 1 to 3 months, a subgroup analysis significantly favored butylcyanoacrylate over SWC. Tissue adhesives significantly lowered the time to complete the procedure, levels of pain, and rate of erythema. However, the data revealed a significant increase in the rate of dehiscence with the use of tissue adhesives when compared with SWC. The low methodologic quality of the evidence should be considered in the interpretation of the findings.
PMCID: PMC2267332  PMID: 18345349
wound closure; tissue bonding; open wounds
9.  A cost-effectiveness study of caesarean-section deliveries by clinical officers, general practitioners and obstetricians in Burkina Faso 
Background
The aim of this paper was to evaluate the effectiveness and cost-effectiveness of alternative training strategies for increasing access to emergency obstetric care in Burkina Faso.
Methods
Case extraction forms were used to record data on 2305 caesarean sections performed in 2004 and 2005 in hospitals in six out of the 13 health regions of Burkina Faso. Main effectiveness outcomes were mothers' and newborns' case fatality rates. The costs of performing caesarean sections were estimated from a health system perspective and Incremental Cost-Effectiveness Ratios were computed using the newborn case fatality rates.
Results
Overall, case mixes per provider were comparable. Newborn case fatality rates (per thousand) varied significantly among obstetricians, general practitioners and clinical officers, at 99, 125 and 198, respectively. The estimated average cost per averted newborn death (x 1000 live births) for an obstetrician-led team compared to a general practitioner-led team was 11 757 international dollars, and for a general practitioner-led team compared to a clinical officer-led team it was 200 international dollars. Training of general practitioners appears therefore to be both effective and cost-effective in the short run. Clinical officers are associated with a high newborn case fatality rate.
Conclusion
Training substitutes is a viable option to increase access to life-saving operations in district hospitals. The high newborn case fatality rate among clinical officers could be addressed by a refresher course and closer supervision. These findings may assist in addressing supply shortages of skilled health personnel in sub-Saharan Africa.
doi:10.1186/1478-4491-7-34
PMCID: PMC2672919  PMID: 19371433
10.  Chronic hypertension and pregnancy outcomes: systematic review and meta-analysis 
Objective To provide an accurate assessment of complications of pregnancy in women with chronic hypertension, including comparison with population pregnancy data (US) to inform pre-pregnancy and antenatal management strategies.
Design Systematic review and meta-analysis.
Data sources Embase, Medline, and Web of Science were searched without language restrictions, from first publication until June 2013; the bibliographies of relevant articles and reviews were hand searched for additional reports.
Study selection Studies involving pregnant women with chronic hypertension, including retrospective and prospective cohorts, population studies, and appropriate arms of randomised controlled trials, were included.
Data extraction Pooled incidence for each pregnancy outcome was reported and, for US studies, compared with US general population incidence from the National Vital Statistics Report (2006).
Results 55 eligible studies were identified, encompassing 795 221 pregnancies. Women with chronic hypertension had high pooled incidences of superimposed pre-eclampsia (25.9%, 95% confidence interval 21.0% to 31.5 %), caesarean section (41.4%, 35.5% to 47.7%), preterm delivery <37 weeks’ gestation (28.1% (22.6 to 34.4%), birth weight <2500 g (16.9%, 13.1% to 21.5%), neonatal unit admission (20.5%, 15.7% to 26.4%), and perinatal death (4.0%, 2.9% to 5.4%). However, considerable heterogeneity existed in the reported incidence of all outcomes (τ2=0.286-0.766), with a substantial range of incidences in individual studies around these averages; additional meta-regression did not identify any influential demographic factors. The incidences (the meta-analysis average from US studies) of adverse outcomes in women with chronic hypertension were compared with women from the US national population dataset and showed higher risks in those with chronic hypertension: relative risks were 7.7 (95% confidence interval 5.7 to 10.1) for superimposed pre-eclampsia compared with pre-eclampsia, 1.3 (1.1 to 1.5) for caesarean section, 2.7 (1.9 to 3.6) for preterm delivery <37 weeks’ gestation, 2.7 (1.9 to 3.8) for birth weight <2500 g, 3.2 (2.2 to 4.4) for neonatal unit admission, and 4.2 (2.7 to 6.5) for perinatal death.
Conclusions This systematic review, reporting meta-analysed data from studies of pregnant women with chronic hypertension, shows that adverse outcomes of pregnancy are common and emphasises a need for heightened antenatal surveillance. A consistent strategy to study women with chronic hypertension is needed, as previous study designs have been diverse. These findings should inform counselling and contribute to optimisation of maternal health, drug treatment, and pre-pregnancy management in women affected by chronic hypertension.
doi:10.1136/bmj.g2301
PMCID: PMC3988319  PMID: 24735917
11.  European Working Time Directive and doctors’ health: a systematic review of the available epidemiological evidence 
BMJ Open  2014;4(7):e004916.
Objective
To summarise the available scientific evidence on the health effects of exposure to working beyond the limit number of hours established by the European Working Time Directive (EWTD) on physicians.
Design
A systematic literature search was conducted in PubMed and EMBASE. Study selection, quality appraisal and data extraction were carried out by independent pairs of researchers using pre-established criteria.
Setting
Physicians of any medical, surgical or community specialty, working in any possible setting (hospitals, primary healthcare, etc), as well as trainees, residents, junior house officers or postgraduate interns, were included.
Participants
The total number of participants was 14 338.
Primary and secondary outcome measures
Health effects classified under the International Classification of Diseases (ICD-10).
Results
Over 3000 citations and 110 full articles were reviewed. From these, 11 studies of high or intermediate quality carried out in North America, Europe and Japan met the inclusion criteria. Six studies included medical residents, junior doctors or house officers and the five others included medical specialists or consultants, medical, dental, and general practitioners and hospital physicians. Evidence of an association was found between percutaneous injuries and road traffic accidents with extended long working hours (LWH)/days or very LWH/weeks. The evidence was insufficient for mood disorders and general health. No studies on other health outcomes were identified.
Conclusions
LWH could increase the risk of percutaneous injuries and road traffic accidents, and possibly other incidents at work through the same pathway. While associations are clear, the existing evidence does not allow for an established causal or ‘dose–response’ relationship between LWH and incidents at work, or for a threshold number of extended hours above which there is a significantly higher risk and the hours physicians could work and remain safe and healthy. Policymakers should consider safety issues when working on relaxing EWTD for doctors.
doi:10.1136/bmjopen-2014-004916
PMCID: PMC4091509  PMID: 25001394
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.  Doctors and patients don't agree: cross sectional study of patients' and doctors' perceptions and assessments of disability in multiple sclerosis. 
BMJ : British Medical Journal  1997;314(7094):1580-1583.
OBJECTIVES: To compare the judgments of clinicians on which domains of health in the short form questionnaire (SF-36) would be most important to patients with multiple sclerosis with the opinions of patients themselves; to compare assessment of physical disability in multiple sclerosis by a clinician using Kurtzke's expanded disability status scale and a non-clinically qualified assistant using the Office of Population Census and Surveys' (OPCS) disability scale with self assessment of disability and other domains of health related quality of life by patients using the SF-36 and the EuroQol questionnaire; and to compare the scores of patients for each domain of the SF-36 with control data matched for age and sex. DESIGN: Cross sectional study. SETTING: Clinical department of neurology, Edinburgh. SUBJECTS: 42 consecutive patients with multiple sclerosis attending a neurology outpatient clinic for review or a neurology ward for rehabilitation. MAIN OUTCOME MEASURES: Scores on the SF-36; EuroQol; Kurtzke's expanded disability status scale; the OPCS disability scale. RESULTS: Patients and clinicians disagreed on which domains of health status were most important (chi 2 = 21, df = 7, P = 0.003). Patients' assessment of their physical disability using the physical functioning domain of the SF-36 was highly correlated with the clinicians' assessment (r = -0.87, P < 0.001) and the non-clinical assessment (r = -0.90, P < 0.001). However, none of the measures of physical disability correlated with overall health related quality of life measured with EuroQol, Quality of life correlated with vitality, general health, and mental health in the SF-36, each of which patients rated as more important than clinicians and for each of which patients scored lower than the controls. CONCLUSIONS: Patients with multiple sclerosis and possibly those with other chronic diseases are less concerned than their clinicians about physical disability in their illness. Clinical trials in multiple sclerosis should assess the effect of treatment on the other elements of health status that patients consider important, which are also affected by the disease process, are more closely related to overall health related quality of life, and may well be adversely affected by side effects of treatment.
PMCID: PMC2126825  PMID: 9169401
14.  Recovery after caesarean birth: a qualitative study of women's accounts in Victoria, Australia 
Background
The caesarean section rate is increasing globally, especially in high income countries. The reasons for this continue to create wide debate. There is good epidemiological evidence on the maternal morbidity associated with caesarean section. Few studies have used women's personal accounts of their experiences of recovery after caesarean. The aim of this paper is to describe women's accounts of recovery after caesarean birth, from shortly after hospital discharge to between five months and seven years after surgery.
Method
Women who had at least one caesarean birth in a tertiary hospital in Victoria, Australia, participated in an interview study. Women were selected to ensure diversity in experiences (type of caesarean, recency), caesarean and vaginal birth, and maternal request caesarean section. Interviews were audiotaped and transcribed verbatim. A theoretical framework was developed (three Zones of clinical practice) and thematic analysis informed the findings.
Results
Thirty-two women were interviewed who between them had 68 births; seven women had experienced both caesarean and vaginal births. Three zones of clinical practice were identified in women's descriptions of the reasons for their first caesareans. Twelve women described how, at the time of their first caesarean section, the operation was performed for potentially life-saving reasons (Central Zone), 11 described situations of clinical uncertainty (Grey Zone), and nine stated they actively sought surgical intervention (Peripheral Zone).
Thirty of the 32 women described difficulties following the postoperative advice they received prior to hospital discharge and their physical recovery after caesarean was hindered by a range of health issues, including pain and reduced mobility, abdominal wound problems, infection, vaginal bleeding and urinary incontinence. These problems were experienced across the three zones of clinical practice, regardless of the reasons women gave for their caesarean.
Conclusion
The women in this study reported a range of unanticipated and unwanted negative physical health outcomes following caesarean birth. This qualitative study adds to the existing epidemiological evidence of significant maternal morbidity after caesarean section and underlines the need for caesarean section to be reserved for circumstances where the benefit is known to outweigh the harms.
doi:10.1186/1471-2393-10-47
PMCID: PMC2939528  PMID: 20718966
15.  Helping pregnant women make better decisions: a systematic review of the benefits of patient decision aids in obstetrics 
BMJ Open  2011;1(2):e000261.
Objectives
Patient decision aids can be used to support pregnant women engaging in shared decisions, but little is known about their effects in obstetrics. The authors aimed to evaluate the effects of patient decision aids designed for pregnant women on clinical and psychosocial outcomes.
Design
Systematic review. Data on all outcomes were extracted and summarised. All studies were critically appraised for potential sources of bias and, when possible to obtain, the reported decision aids were evaluated. Meta-analysis was not possible due to the heterogeneity of outcomes in primary studies and the small number of studies.
Data sources
Electronic searches were performed using Medline, Embase, the Cochrane Library and Medion databases from inception until December 2010. Reference lists of all included articles were also examined and key experts contacted.
Eligibility criteria for selecting studies
Eligibility criteria included randomised controlled trials, which reported on patient decision aids for women facing any treatment decision in pregnancy published in English. Studies evaluating health education material that did not address women's values and preferences were excluded.
Results
Patient decision aids have been developed for decisions about prenatal testing, vaginal birth after Caesarean section, external cephalic version and labour analgesia. Use of decision aids is associated with a number of positive effects including reduced anxiety, lower decisional conflict, improved knowledge, improved satisfaction and increased perception of having made an informed choice.
Conclusions
Patient decision aids have the potential to improve obstetric care. However, currently the evidence base is limited by the small number of studies, the quality of the studies and because they involved heterogeneous decision aids, patient groups and outcomes.
Article summary
Article focus
Engaging pregnant women in shared decision making has become a priority for maternity care but remains a challenge for many health professionals.
Patient decision aids can be used to facilitate patient involvement in decision making and improve clinical practice. They are interventions, which provide information about options and outcomes as well as clarifying the user's values. However, little is known about their effects in obstetrics.
We aimed to evaluate the effects of decision aids designed for pregnant women on clinical and psychosocial outcomes.
Key messages
Eleven randomised controlled trials were identified investigating the effects of patient decision aids on a range of outcomes.
Use of patient decision aids was associated with a number of positive effects including: reduced anxiety (three studies), improved knowledge (seven studies), improved satisfaction (two studies), increased perception of having made an informed choice (one study) and lower decisional conflict (five studies).
Further research is needed to expand this limited evidence base and to develop better outcomes to assess the quality of decision making.
Strengths and limitations of this study
This is the first systematic review of patient decision aids in obstetrics and provides a comprehensive and critical review of the available evidence.
A number of potential benefits supporting the use of decision aids in clinical practice were identified.
The limited evidence base was demonstrated aiming to stimulate the development of further decision aids and research into evaluation and implementation of them.
There is need to be cautious in interpreting the potential benefit of decision aids in routine practice in pregnancy due to the limitations of the small number of randomised controlled trials and the inconsistencies in their results.
Meta-analysis could not be performed due to the small sample size and heterogeneity of primary outcomes chosen.
doi:10.1136/bmjopen-2011-000261
PMCID: PMC3334824  PMID: 22189349
16.  Effects of caesarean section on maternal health in low risk nulliparous women: a prospective matched cohort study in Shanghai, China 
Background
Rates of caesarean section are progressively increasing in many parts of the world. As a result of psychosocial factors there has been an increasing tendency for pregnant women without justifiable medical indications for caesarean section to ask for this procedure in China. A critical examination of this issue in relation to maternal outcomes is important. At present there are no clinical trials to help assess the risks and benefits of caesarean section in low risk women. To fill the gap left by trials, this indication-matched cohort study was carried out to examine prospectively the outcomes of caesarean section on women with no absolute obstetric indication compared with similar women who had vaginal delivery.
Methods
An indication-matched cohort study was undertaken to compare maternal outcomes following caesarean section with those undergoing vaginal delivery, in which the two groups were matched for non-absolute indications. 301 nulliparous women with caesarean section were matched successfully with 301 women who delivered vaginally in the Maternal and Children's Hospitals (MCHs) in Shanghai, China. Logistic regression model or binomial regression model was used to estimate the relative risk (RR) directly. Adjusted RRs were calculated adjusting for propensity score and medical indications.
Results
The incidence of total complications was 2.2 times higher in the caesarean section group during hospitalization post-partum, compared with the vaginal delivery group (RR = 2.2; 95% CI: 1.1-4.4). The risk of haemorrhage from the start of labour until 2 hours post-partum was significantly higher in the caesarean group (RR = 5.6; 95% CI: 1.2-26.9). The risk of chronic abdominal pain was significantly higher for the caesarean section group (RR = 3.6; 95% CI: 1.2-10.9) than for the vaginal delivery group within 12 months post-partum. The two groups had similar incidences of anaemia and complicating infections such as wound complications or urinary tract infection.
Conclusions
In nulliparous women who were at low risk, caesarean section was associated with a higher rate of post-partum morbidity. Those requesting the surgical procedure with no conventional medical indication, should be advised of the potential risks.
doi:10.1186/1471-2393-10-78
PMCID: PMC3014869  PMID: 21122153
17.  Doctors' emotional reactions to recent death of a patient: cross sectional study of hospital doctors 
BMJ : British Medical Journal  2003;327(7408):185.
Objectives: To describe doctors' emotional reactions to the recent death of an “average” patient and to explore the effects of level of training on doctors' reactions.
Design: Cross sectional study using quantitative and qualitative data.
Setting: Two academic teaching hospitals in the United States.
Participants: 188 doctors (attending physicians (equivalent to UK consultants), residents (equivalent to UK senior house officers), and interns (equivalent to UK junior house officers)) who cared for 68 patients who died in the hospital.
Main outcome measures: Doctors' experiences in providing care, their emotional reactions to the patient's death, and their use of coping and social resources to manage their emotions.
Results: Most doctors (139/188, 74%) reported satisfying experiences in caring for a dying patient. Doctors reported moderate levels of emotional impact (mean 4.7 (SD 2.4) on a 0-10 scale) from the death. Women and those doctors who had cared for the patient for a longer time experienced stronger emotional reactions. Level of training was not related to emotional reactions, but interns reported needing significantly more emotional support than attending physicians. Although most junior doctors discussed the patient's death with an attending physician, less than a quarter of interns and residents found senior teaching staff (attending physicians) to be the most helpful source of support.
Conclusions: Doctors who spend a longer time caring for their patients get to know them better but this also makes them more vulnerable to feelings of loss when these patients die. Medical teams may benefit from debriefing within the department to give junior doctors an opportunity to share emotional responses and reflect on the patient's death.
PMCID: PMC166122  PMID: 12881257
18.  Effectiveness of strategies incorporating training and support of traditional birth attendants on perinatal and maternal mortality: meta-analysis 
Objective To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries.
Design Systematic review with meta-analysis.
Data sources Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were “birth attend*”, “traditional midwife”, “lay birth attendant”, “dais”, and “comadronas”.
Review methods We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model.
Results We identified six cluster randomised controlled trials (n=138 549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, P<0.001; number needed to treat 35, 24 to 70) and neonatal death (0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170). Meta-analysis of the non-randomised studies also showed a significant reduction in perinatal mortality (0.70, 0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal mortality (0.61, 0.48 to 0.75, P<0.001; 96, 65 to 168). Six studies reported on maternal mortality and our meta-analysis showed a non-significant reduction (three randomised trials, relative risk 0.79, 0.53 to 1.05, P=0.12; three non-randomised studies, 0.80, 0.44 to 1.15, P=0.26).
Conclusion Perinatal and neonatal deaths are significantly reduced with strategies incorporating training and support of traditional birth attendants.
doi:10.1136/bmj.d7102
PMCID: PMC3228291  PMID: 22134967
19.  Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period 
Background
Venous thromboembolic disease (TED), although rare, is a major cause of maternal mortality and morbidity, hence methods of prophylaxis are often used for women at risk. This may include women delivered by caesarean section, those with a personal or family history of TED and women with inherited or acquired thrombophilias (conditions that predispose people to thrombosis). Many methods of prophylaxis carry a risk of side effects, and as the risk of TED is low, it is possible that the benefits of thromboprophylaxis may be outweighed by harm. Current guidelines for clinical practice are based on expert opinion only, rather than high quality evidence from randomised trials.
Objectives
To determine the effects of thromboprophylaxis in women who are pregnant or have recently delivered and are at increased risk of TED on the incidence of venous TED and side effects of treatment.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (May 2009).
Selection criteria
Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, and randomised trials comparing two (or more) methods of thromboprophylaxis.
Data collection and analysis
Two review authors extracted data independently and resolved any discrepancies by discussion.
Main results
Sixteen trials met the inclusion criteria but only 13 trials, involving 1774 women, examining a range of methods of thromboprophylaxis, contributed data for the outcomes of interest. Four of them compared methods of antenatal prophylaxis: low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) (two studies), and heparin versus no treatment (two studies). Eight studies assessed postnatal prophylaxis after caesarean section; one compared hydroxyethyl starch with unfractionated heparin; four compared heparin with placebo; and the other three compared UFH with LMWH. One study examined prophylaxis in the postnatal period.
The small number of statistically significant findings in this review are largely derived from trials which are not of high methodological quality. It was not possible to assess the effects of any of these interventions on most outcomes, and especially on rare outcomes such as death, TED and osteoporosis, because of small sample sizes and the small number of trials making the same comparisons.There was some evidence of side effects associated with thromboprophylaxis.
Authors’ conclusions
There is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period. Large scale randomised trials of currently-used interventions should be conducted.
doi:10.1002/14651858.CD001689.pub2
PMCID: PMC4175551  PMID: 20464719
Postpartum Period; Pregnancy Complications, Hematologic [* prevention & control]; Randomized Controlled Trials as Topic; Venous Thrombosis [* prevention & control]; Female; Humans; Pregnancy
20.  Restricting oral fluid and food intake during labour 
Background
Restricting fluids and foods during labour is common practice across many birth settings with some women only being allowed sips of water or ice chips. Restriction of oral intake may be unpleasant for some women, and may adversely influence their experience of labour.
Objectives
To determine the benefits and harms of oral fluid or food restriction during labour.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (April 2009).
Selection criteria
Randomised controlled trials (RCTs) and quasi-RCTs of restricting fluids and food for women in labour compared with women free to eat and drink.
Data collection and analysis
Two authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction.
Main results
We identified five studies (3130 women). All studies looked at women in active labour and at low risk of potentially requiring a general anaesthetic. One study looked at complete restriction versus giving women the freedom to eat and drink at will; two studies looked at water only versus giving women specific fluids and foods and two studies looked at water only versus giving women carbohydrate drinks.
When comparing any restriction of fluids and food versus women given some nutrition in labour, the meta-analysis was dominated by one study undertaken in a highly medicalised environment. There were no statistically significant differences identified in: caesarean section (average risk ratio (RR) 0.89, 95% confidence interval (CI) 0.63 to 1.25, five studies, 3103 women), operative vaginal births (average RR 0.98, 95% CI 0.88 to 1.10, five studies, 3103 women) and Apgar scores less than seven at five minutes (average RR 1.43, 95% CI 0.77 to 2.68, three studies, 2574 infants), nor in any of the other outcomes assessed. Women’s views were not assessed. The pooled data were insufficient to assess the incidence of Mendelson’s syndrome, an extremely rare outcome. Other comparisons showed similar findings, except one study did report a significant increase in caesarean sections for women taking carbohydrate drinks in labour compared with water only, but these results should be interpreted with caution as the sample size was small.
Authors’ conclusions
Since the evidence shows no benefits or harms, there is no justification for the restriction of fluids and food in labour for women at low risk of complications. No studies looked specifically at women at increased risk of complications, hence there is no evidence to support restrictions in this group of women. Conflicting evidence on carbohydrate solutions means further studies are needed and it is critical in any future studies to assess women’s views.
doi:10.1002/14651858.CD003930.pub2
PMCID: PMC4175539  PMID: 20091553
*Drinking; *Fasting [adverse effects]; *Labor, Obstetric; Beverages [adverse effects]; Dietary Carbohydrates [administration & dosage; adverse effects]; Randomized Controlled Trials as Topic; Female; Humans; Pregnancy
21.  The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial 
Background
Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in many developed countries. Rates in other parts of the world vary widely.
A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings.
Design
CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan.
Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision.
Five comparisons will be carried out in one trial, using a 2 × 2 × 2 × 2 × 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are:
• Blunt versus sharp abdominal entry
• Exteriorisation of the uterus for repair versus intra-abdominal repair
• Single versus double layer closure of the uterus
• Closure versus non-closure of the peritoneum (pelvic and parietal)
• Chromic catgut versus Polyglactin-910 for uterine repair
The primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis) or further operative procedures; or blood transfusion.
The sample size required is 15,000 women in total; at least 7,586 women in each comparison.
Discussion
Improvements in health from optimising caesarean section techniques are likely to be more significant in developing countries, because the rates of postoperative morbidity in these countries tend to be higher. More women could therefore benefit from improvements in techniques.
Trial registration
The CORONIS Trial is registered in the Current Controlled Trials registry. ISCRTN31089967.
doi:10.1186/1471-2393-7-24
PMCID: PMC2217555  PMID: 18336721
22.  Interventions for helping to turn term breech babies to head first presentation when using external cephalic version 
Background
Breech presentation is associated with increased complications. Turning a breech baby to head first presentation using external cephalic version (ECV) attempts to reduce the chances of breech presentation at birth, and reduce the adverse effects of breech vaginal birth or caesarean section. Tocolytic drugs and other methods have been used in an attempt to facilitate ECV.
Objectives
To assess interventions such as tocolysis, fetal acoustic stimulation, regional analgesia, transabdominal amnioinfusion or systemic opioids on ECV for a breech baby at term.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 September 2011) and the reference lists of identified studies.
Selection criteria
Randomised and quasi-randomised trials comparing the above interventions with no intervention or other methods to facilitate ECV at term.
Data collection and analysis
We assessed eligibility and trial quality. Two review authors independently assessed for inclusion all potential studies identified as a result of the search strategy and independently extracted the data using a designed data extraction form.
Main results
We included 25 studies, providing data on 2548 women. We used the random-effects model for pooling data due to clinical heterogeneity in the included studies in the various comparisons. The overall quality of the evidence was reasonable, but a number of assessments had insufficient data to provide an answer with any degree of assurance.
Tocolytic drugs, in particular betastimulants, were effective in increasing cephalic presentations in labour (average risk ratio (RR) 1.38, 95% confidence interval (CI) 1.03 to 1.85, eight studies, 993 women) and in reducing the number of caesarean sections (average RR 0.82, 95% CI 0.71 to 0.94, eight studies, 1177 women). No differences were identified in fetal bradycardias (average RR 0.95, 95% CI 0.48 to 1.89, three studies, 467 women) although the review is underpowered for assessing this outcome. We identified no difference in success, cephalic presentation in labour and caesarean sections between nulliparous and multiparous women. There were insufficient data comparing different groups of tocolytic drugs. Sensitivity analyses by study quality agreed with the overall findings.
Regional analgesia in combination with a tocolytic was more effective than the tocolytic alone in terms of increasing successful versions (assessed by the rate of failed ECVs, average RR 0.67, 95% CI 0.51 to 0.89, six studies, 550 women) but there was no difference identified in cephalic presentation in labour (average RR 1.63, 95% CI 0.75 to 3.53, three studies, 279 women) nor in caesarean sections (average RR 0.74, 95% CI 0.40 to 1.37, three studies, 279 women) or fetal bradycardia (average RR 1.48, 95% CI 0.62 to 3.57, two studies, 210 women).
There were insufficient data on the use of vibroacoustic stimulation, amnioinfusion or systemic opioids.
Authors’ conclusions
Betastimulants, to facilitate ECV, increased cephalic presentation in labour and birth, and reduced the caesarean section rate in both nulliparous and multiparous women, but there were insufficient data on adverse effects. Calcium channel blockers and nitric acid donors had insufficient data to provide good evidence. At present we recommend betamimetics for facilitating ECV.
There is scope for further research. The possible benefits of tocolysis to reduce the force required for successful version and the possible risks of maternal cardiovascular side effects, need to be addressed further. Further trials are needed to compare the effectiveness of routine versus selective use of tocolysis, the role of regional analgesia, fetal acoustic stimulation, amnioinfusion and the effect of intravenous or oral hydration prior to ECV.
Although randomised trials of nitroglycerine are small, the results are sufficiently negative to discourage further trials.
doi:10.1002/14651858.CD000184.pub3
PMCID: PMC4171393  PMID: 22258940
Analgesia, Obstetrical [methods]; Breech Presentation [* prevention & control]; Calcium Channel Blockers [therapeutic use]; Delivery, Obstetric; Nitroglycerin [therapeutic use]; Randomized Controlled Trials as Topic; Tocolysis [* methods]; Tocolytic Agents [therapeutic use]; Version, Fetal [* methods]; Vibration [therapeutic use]; Female; Humans; Pregnancy
23.  Reducing the incidence of infection after caesarean section: implications of prophylaxis with antibiotics for hospital resources. 
BMJ : British Medical Journal  1989;299(6706):1003-1006.
OBJECTIVES--To estimate the cost effectiveness of giving prophylactic antibiotics routinely to reduce the incidence of wound infection after caesarean section. DESIGN--Estimation of cost effectiveness was based, firstly, on a retrospective overview of 58 controlled trials and, secondly, on evidence about costs derived from data and observations of practice. SETTING--Trials included in the overview were from obstetric units in several different countries, including the United Kingdom. The costing study was based on data referring to the John Radcliffe Maternity Hospital, Oxford. SUBJECTS--A total of 7777 women were included in the 58 controlled trials comparing the effects of giving routine prophylactic antibiotics at caesarean section with either treatment with a placebo or no treatment. Cost estimates were based on data on 486 women who had caesarean sections between January and September 1987. MAIN OUTCOME MEASURE--Cost effectiveness of prophylaxis with antibiotics. RESULTS--The odds of wound infection are likely to be reduced by between about 50 and 70% by giving antibiotics routinely at caesarean section. Forty one (8.4%) women who had caesarean section were coded by the Oxford obstetric data system as having developed wound infection. The additional average cost of hospital postnatal care for women with wound infection (compared with women who had had caesarean section and no wound infection) was estimated to be 716 pounds; introducing routine prophylaxis with antibiotics would reduce average costs of postnatal care by between 1300 pounds and 3900/100 pounds caesarean sections (at 1988 prices), depending on the cost of the antibiotic used and its effectiveness. CONCLUSIONS--The results suggest that giving antibiotics routinely at caesarean section will not only reduce rates of infection after caesarean section but also reduce costs.
PMCID: PMC1837925  PMID: 2511938
24.  Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis 
Objective To compare the clinical outcomes of staples versus sutures in wound closure after orthopaedic surgery.
Design Meta-analysis.
Data sources Medline, CINAHL, AMED, Embase, Scopus, and the Cochrane Library databases were searched, in addition to the grey literature, in all languages from 1950 to September 2009. Additional studies were identified from cited references.
Selection criteria Two authors independently assessed papers for eligibility. Included studies were randomised and non-randomised controlled trials that compared the use of staples with suture material for wound closure after orthopaedic surgery procedures. All studies were included, and publications were not excluded because of poor methodological quality.
Review methods Two authors independently reviewed studies for methodological quality and extracted data from each paper. Final data for analysis were collated through consensus. The primary outcome measure was the assessment of superficial wound infection after wound closure with staples compared with sutures. Relative risk and mean difference with 95% confidence intervals were calculated and pooled with a random effects model. Heterogeneity was assessed with I2 and χ2 statistical test.
Results Six papers, which included 683 wounds, were identified; 332 patients underwent suture closure and 351 staple closure. The risk of developing a superficial wound infection after orthopaedic procedures was over three times greater after staple closure than suture closure (relative risk 3.83, 95% confidence interval 1.38 to 10.68; P=0.01). On subgroup analysis of hip surgery alone, the risk of developing a wound infection was four times greater after staple closure than suture closure (4.79, 1.24 to 18.47; P=0.02). There was no significant difference between sutures and staples in the development of inflammation, discharge, dehiscence, necrosis, and allergic reaction. The included studies had several major methodological limitations, including the recruitment of small, underpowered cohorts, poorly randomising patients, and not blinding assessors to the allocated methods of wound closure. Only one study had acceptable methodological quality.
Conclusions After orthopaedic surgery, there is a significantly higher risk of developing a wound infection when the wound is closed with staples rather than sutures. This risk is specifically greater in patients who undergo hip surgery. The use of staples for closing hip or knee surgery wounds after orthopaedic procedures cannot be recommended, though the evidence comes from studies with substantial methodological limitations. Though we advise orthopaedic surgeons to reconsider their use of staples for wound closure, definitive randomised trials are still needed to assess this research question.
doi:10.1136/bmj.c1199
PMCID: PMC2840224  PMID: 20234041
25.  Conventional versus automated measurement of blood pressure in primary care patients with systolic hypertension: randomised parallel design controlled trial 
Objective To compare the quality and accuracy of manual office blood pressure and automated office blood pressure using the awake ambulatory blood pressure as a gold standard.
Design Multi-site cluster randomised controlled trial.
Setting Primary care practices in five cities in eastern Canada.
Participants 555 patients with systolic hypertension and no serious comorbidities under the care of 88 primary care physicians in 67 practices in the community.
Interventions Practices were randomly allocated to either ongoing use of manual office blood pressure (control group) or automated office blood pressure (intervention group) using the BpTRU device. The last routine manual office blood pressure (mm Hg) was obtained from each patient’s medical record before enrolment. Office blood pressure readings were compared before and after enrolment in the intervention and control groups; all readings were also compared with the awake ambulatory blood pressure.
Main outcome measure Difference in systolic blood pressure between awake ambulatory blood pressure minus automated office blood pressure and awake ambulatory blood pressure minus manual office blood pressure.
Results Cluster randomisation allocated 31 practices (252 patients) to manual office blood pressure and 36 practices (303 patients) to automated office blood pressure measurement. The most recent routine manual office blood pressure (149.5 (SD 10.8)/81.4 (8.3)) was higher than automated office blood pressure (135.6 (17.3)/77.7 (10.9)) (P<0.001). In the control group, routine manual office blood pressure before enrolment (149.9 (10.7)/81.8 (8.5)) was reduced to 141.4 (14.6)/80.2 (9.5) after enrolment (P<0.001/P=0.01), but the reduction in the intervention group from manual office to automated office blood pressure was significantly greater (P<0.001/P=0.02). On the first study visit after enrolment, the estimated mean difference for the intervention group between the awake ambulatory systolic/diastolic blood pressure and automated office blood pressure (−2.3 (95% confidence interval −0.31 to −4.3)/−3.3 (−2.7 to −4.4)) was less (P=0.006/P=0.26) than the difference in the control group between the awake ambulatory blood pressure and the manual office blood pressure (−6.5 (−4.3 to −8.6)/−4.3 (−2.9 to −5.8)). Systolic/diastolic automated office blood pressure showed a stronger (P<0.001) within group correlation (r=0.34/r=0.56) with awake ambulatory blood pressure after enrolment compared with manual office blood pressure versus awake ambulatory blood pressure before enrolment (r=0.10/r= 0.40); the mean difference in r was 0.24 (0.12 to 0.36)/0.16 (0.07 to 0.25)). The between group correlation comparing diastolic automated office blood pressure and awake ambulatory blood pressure (r=0.56) was stronger (P<0.001) than that for manual office blood pressure versus awake ambulatory blood pressure (r=0.30); the mean difference in r was 0.26 (0.09 to 0.41). Digit preference with readings ending in zero was substantially reduced by use of automated office blood pressure.
Conclusion In compliant, otherwise healthy, primary care patients with systolic hypertension, introduction of automated office blood pressure into routine primary care significantly reduced the white coat response compared with the ongoing use of manual office blood pressure measurement. The quality and accuracy of automated office blood pressure in relation to the awake ambulatory blood pressure was also significantly better when compared with manual office blood pressure.
Trial registration Clinical trials NCT 00214053.
doi:10.1136/bmj.d286
PMCID: PMC3034423  PMID: 21300709

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