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1.  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
2.  Clinicians and the coronial system: ability of clinicians to recognise reportable deaths. 
BMJ : British Medical Journal  1993;306(6884):1038-1041.
OBJECTIVE--To assess the ability of clinicians to recognise deaths which require referral to the coroner. DESIGN--Postal questionnaire consisting of 16 fictitious case histories, 14 of which contained a clear indication for referral to the coroner. SETTING--Large teaching hospital. Coroner's office. SUBJECTS--200 clinicians from general medical and surgical firms and senior staff of the local coroner's office (two coroner's officers and the two deputy coroners). MAIN OUTCOME MEASURES--Number of correct assessments on questionnaire. RESULTS--The mean recognition score for the clinicians was 9.11 (range 3-14) with no difference between the clinical grades. All of the coroner's senior staff recorded maximum recognition scores of 16. CONCLUSIONS--The study highlights several features of the coronial system which are poorly understood by clinicians and provides the basis for an initiative to improve the medicolegal education of all clinicians.
PMCID: PMC1677018  PMID: 8490498
3.  Maternal and Fetal Effect of Misgav Ladach Cesarean Section in Nigerian Women: A Randomized Control Study 
Background:
The poor utilisation of the Misgav-Ladach (ML) caesarean section method in our environment despite its proven advantage has been attributed to several factors including its non-evaluation. A well designed and conducted trial is needed to provide evidence to convince clinician of its advantage over Pfannenstiel based methods.
Aim:
To evaluate the outcome of ML based caesarean section among Nigerian women.
Subjects and Methods:
Randomised controlled open label study of 323 women undergoing primary caesarean section in Lagos Nigeria. The women were randomised to either ML method or Pfannenstiel based (PB) caesarean section technique using computer generated random numbers.
Results:
The mean duration of surgery (P < 0.001), time to first bowel motion (P = 0.01) and ambulation (P < 0.001) were significantly shorter in the ML group compared to PB group. Postoperative anaemia (P < 0.01), analgesic needs (P = 0.02), extra suture use, estimated blood loss (P < 0.01) and post-operative complications (P = 0.001) were significantly lower in the ML group compared to PB group. Though the mean hospital stay was shorter (5.8 days) in the ML group as against 6.0 days, the difference was not significant statistically (P = 0.17). Of the fetal outcome measures compared, it was only in the fetal extraction time that there was significant difference between the two groups (P = 0.001). The mean fetal extraction time was 162 sec in ML group compared to 273 sec in the PB group.
Conclusions:
This study confirmed the already established benefit of ML techniques in Nigerian women, as it relates to the postoperative outcomes, duration of surgery, and fetal extraction time. The technique is recommended to clinicians as its superior maternal and fetal outcome and cost saving advantage makes it appropriate for use in poor resource setting.
doi:10.4103/2141-9248.122119
PMCID: PMC3868127  PMID: 24380012
Cesarean section; Maternal and neonatal morbidity; Misgav Ladach
4.  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
5.  Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon®) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section 
Background
Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death.
The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion.
Methods and design
A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha.
Discussion
It is both important and timely that we evaluate the optimal approach to the management of the third stage at elective caesarean section. Safe operative delivery is now a priority and a reality for many pregnant women. Obstetricians, obstetric anaesthetists, midwives and pregnant women need high quality evidence on which to base management approaches. The overall aim is to reduce maternal haemorrhagic morbidity and its attendant risks at elective caesarean section.
Trial registration
number: ISRCTN17813715
doi:10.1186/1471-2393-9-36
PMCID: PMC2739153  PMID: 19703279
6.  Comparison of suture material and technique of closure of subcutaneous fat and skin in caesarean section 
Background:
A large number of women undergo caesarean section throughout the world. These women pass through a period of post operative pain and a morbidity period. These women translate into a substantial portion of population and hence there is a load on the financial resources of healthcare system. Use of the appropriate technique to approximate the wound after caesarean section would not only avoid financial load but also help in early recovery of the patient.
Aim:
The aim of this study is to compare the effects of alternative techniques for closure of subcutaneous fat and skin on maternal health and use of healthcare resources in caesarean section.
Materials and Methods:
Patients undergoing Caesarean section were divided in two groups of one thousand patients each. Patients with hematological disorders or a malignancy, diabetes, septicemia or chorioamnionitis were excluded from the study. In all the patients, after stitching the uterus, the rectus sheath was stitched with thread vicryl No.1 (synthetic absorbable braided sutures with polyglycolic acid, polycaprolactone and calcium stearate coating), using a round body needle. Then the patients were divided into two groups. In group I, vicryl No.1 thread used in stitching of the rectus sheath was continued into the skin with application of subcuticular stitches, after securing the edges with a knot. In group II, after stitching the rectus sheath with vicryl No. 1, the thread was cut and interrupted sutures were applied in subcutaneous fat with thread vicryl No. 2. Skin was stitched with subcuticular stitches using proline 2, a non-absorbable propylene suture. The two groups of patients were observed for the duration of surgery, post-operative pain in stitches, patient satisfaction about removal of stitches, evidence of wound infection or seroma, and cosmetic results.
Results:
It was noted that the duration of surgery in group I was on average 7.5 minutes less as compared to the duration in group II. Patients in group I were more satisfied with the results of the surgery and were relieved to know that their stitches did not need to be removed.
Conclusion:
Although no difference was found in the rates of wound infection and formation of scar tissue between the group I and group II, the duration of surgery was less and the patients were more satisfied in group I.
doi:10.4297/najms.2011.385
PMCID: PMC3336893  PMID: 22540072
Subcuticular stitches; intradermal stitches; suture material
7.  Birth after caesarean study – planned vaginal birth or planned elective repeat caesarean for women at term with a single previous caesarean birth: protocol for a patient preference study and randomised trial 
Background
For women who have a caesarean section in their preceding pregnancy, two care policies for birth are considered standard: planned vaginal birth and planned elective repeat caesarean. Currently available information about the benefits and harms of both forms of care are derived from retrospective and prospective cohort studies. There have been no randomised trials, and recognising the deficiencies in the literature, there have been calls for methodologically rigorous studies to assess maternal and infant health outcomes associated with both care policies.
The aims of our study are to assess in women with a previous caesarean birth, who are eligible in the subsequent pregnancy for a vaginal birth, whether a policy of planned vaginal birth after caesarean compared with a policy of planned repeat caesarean affects the risk of serious complications for the woman and her infant.
Methods/Design
Design: Multicentred patient preference study and a randomised clinical trial.
Inclusion Criteria: Women with a single prior caesarean presenting in their next pregnancy with a single, live fetus in cephalic presentation, who have reached 37 weeks gestation, and who do not have a contraindication to a planned VBAC.
Trial Entry & Randomisation: Eligible women will be given an information sheet during pregnancy, and will be recruited to the study from 37 weeks gestation after an obstetrician has confirmed eligibility for a planned vaginal birth. Written informed consent will be obtained. Women who consent to the patient preference study will be allocated their preference for either planned VBAC or planned, elective repeat caesarean. Women who consent to the randomised trial will be randomly allocated to either the planned vaginal birth after caesarean or planned elective repeat caesarean group.
Treatment Groups: Women in the planned vaginal birth group will await spontaneous onset of labour whilst appropriate. Women in the elective repeat caesarean group will have this scheduled for between 38 and 40 weeks.
Primary Study Outcome: Serious adverse infant outcome (death or serious morbidity).
Sample Size: 2314 women in the patient preference study to show a difference in adverse neonatal outcome from 1.6% to 3.6% (p = 0.05, 80% power).
Clinical Trial Registration
ISCTRN5397431
doi:10.1186/1471-2393-7-17
PMCID: PMC1988834  PMID: 17697343
8.  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
9.  Families’ reflections on the process of brain donation following coronial autopsy 
Cell and Tissue Banking  2010;13(1):89-101.
This study aims to explore families’ reflections on their decision to donate brain tissue to the NSW Tissue Resource Centre (NSW TRC), Australia. Specifically, the study aims to investigate respondents’ initial reactions to the request for donation, primary reasons for their decision, and subsequent satisfaction levels. Participants were next-of-kin (NOK) contacted between May 2002 and May 2008, on the day of their relative’s autopsy, who agreed to donate brain tissue to the NSW TRC for medical research. All 111 NOK were invited to participate, and those who agreed completed an anonymous questionnaire. Fifty completed questionnaires were received. Results showed that 74% of respondents were not upset by the donation call and 98% were satisfied with their decision to donate. Of the 22% who reported having been upset, many indicated that their distress was partly related to their circumstances. When asked the main reason for their donation, 66% had wanted to help others, or help research, while 24% stated their primary reason as a belief that they were respecting the wishes of their deceased relative. These findings show that NOK are not further distressed by being asked to donate brain tissue, give altruistic reasons for consent and are satisfied with the decision they made. In both this study and previous literature, the importance of discussion about organ donation amongst relatives is a recurring theme. Knowledge about a relative’s wishes is likely to help facilitate decision-making, overcoming at least one crucial barrier to lifting rates of organ donation for transplantation and research.
doi:10.1007/s10561-010-9233-1
PMCID: PMC3154613  PMID: 21140229
Organ; Brain; Donation; Coronial; Distress; Satisfaction
10.  Efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection: study protocol for a randomized controlled trial 
Trials  2012;13:89.
Background
Caesarean section is a commonly performed operation worldwide. It has been found to increase rates of maternal infectious morbidities more than five times when compared to vaginal delivery. Provision of intravenous prophylactic antibiotics 30 to 60 minutes prior to caesarean section has been found to reduce post-caesarean infection tremendously. Many centers recommend provision of a single dose of antibiotics, as repeated doses offer no benefit over a single dose.
At Bugando Medical Centre post caesarean infection is among the top five causes of admission at the post-natal ward. Unfortunately, there is no consistent protocol for the administration of antibiotic prophylaxis to patients who are designated for caesarean section. Common practice and generally the clinician’s preference are to provide repeated dosages of antibiotic prophylaxis after caesarean section to most of the patients. This study aims to determine the comparative efficacy of a single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post caesarean infection.
Methods/Design
The study is an interventional, open-label, two-armed, randomized, single-center study conducted at Bugando Medical Centre Mwanza, Tanzania. It is an ongoing trial for the period of seven months; 490 eligible candidates will be enrolled in the study. Study subjects will be randomly allocated into two study arms; “A” and “B”. Candidates in “A” will receive a single dose of gentamicin in combination with metronidazole 30 to 60 minutes prior to the operation and candidates in “B” will receive the same drugs prior to the operation and continue with gentamicin and metronidazole for 24 hours. The two groups will be followed up for a period of one month and assessed for signs and symptoms of surgical site infection.
Data will be extracted from a case record form and entered into Epi data3.1 software before being transferred to SPSS version 17.0 for analysis. The absolute difference in proportion of women who develop surgical site infection in the two study arms will be the effectiveness of one regime over the other.
Trial registration
Current Controlled TrialsISRCTN44462542.
doi:10.1186/1745-6215-13-89
PMCID: PMC3475059  PMID: 22720689
Post-caesarean infection; Metronidazole; Gentamicin; Mwanza; Tanzania
11.  Randomised Trial of Planned Caesarean Section Prior to Versus after 39 Weeks: Unscheduled Deliveries and Facility Logistics - A Secondary Analysis 
PLoS ONE  2013;8(12):e84744.
Objectives
To compare the impact of scheduling caesarean section prior to versus after 39 completed weeks of gestation on the occurrence of unscheduled caesarean section and rescheduling of the procedure.
Methods
Secondary analysis from a multicentre randomised open-label trial including singleton pregnant women with a healthy foetus and a reliable due date. Women were allocated by computerized telephone randomisation to planned caesarean section at 38 weeks and three days or 39 weeks and three days. The outcomes were unscheduled deliveries with provided reasons, such as spontaneous labour onset or supervening complications, and any changes in the scheduled delivery date. Statistical analyses were according to intention-to-treat using Fisher’s exact test.
Results
From March 2009 to June 2011 1,274 women were included. Median difference in gestational age at delivery was six days. Compared to the 38 weeks group, the women in the 39 weeks group were more likely to have an unscheduled caesarean section (15.2% vs. 9.3%; RR 1.64, 95% CI 1.21; 2.22), to deliver between 6 pm and 8 am (10 % vs. 6%; RR 1.68, 95% CI 1.14; 2.47), or to have the procedure rescheduled (36.7% vs. 23%; RR 1.6, 95% CI 1.34;1.90).
Conclusions
Scheduling caesarean section after 39 weeks leads to a 60% increase in unscheduled caesarean sections and a 70% increase in delivery outside regular work hours as compared to scheduling of the procedure prior to 39 weeks.
Trial Registration
www.clinicaltrials.gov NCT00835003 http://www.clinicaltrials.gov/ct2/show/NCT00835003?term=NCT00835003&rank=1
doi:10.1371/journal.pone.0084744
PMCID: PMC3869904  PMID: 24376842
12.  Does continuity of care impact decision making in the next birth after a caesarean section (VBAC)? a randomised controlled trial 
Background
Caesarean section (CS) has short and long-term health effects for both the woman and her baby. One of the greatest contributors to the CS rate is elective repeat CS. Vaginal birth after caesarean (VBAC) is an option for many women; despite this the proportion of women attempting VBAC remains low. Potentially the relationship that women have with their healthcare professional may have a major influence on the uptake of VBAC. Models of service delivery, which enable an individual approach to care, may make a difference to the uptake of VBAC. Midwifery continuity of care could be an effective model to encourage and support women to choose VBAC.
Methods/Design
A randomised, controlled trial will be undertaken. Eligible pregnant women, whose most recent previous birth was by lower-segment CS, will be randomly allocated 1:1 to an intervention group or control group. The intervention provides midwifery continuity of care to women through pregnancy, labour, birth and early postnatal care. The control group will receive standard hospital care from different midwives through pregnancy, labour, birth and early postnatal care. Both groups will receive an obstetric consultation during pregnancy and at any other time if required. Clinical care will follow the same guidelines in both groups.
Discussion
This study will determine whether midwifery continuity of care influences the decision to attempt a VBAC and impacts on mode of birth, maternal experiences with care and the health of the neonate. Outcomes from this study might influence the way maternity care is provided to this group of women and thus impact on the CS rate. This information will provide high level evidence to policy makers, health service managers and practitioners who are working towards addressing the increased rate of CS.
Trial registration
This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611001214921
doi:10.1186/1471-2393-13-140
PMCID: PMC3717054  PMID: 23819882
Vaginal birth; Obstetrics; Caesarean section; Midwifery care; Vaginal birth after caesarean
13.  Effect of Supplementing Oxygen with Positive end Expiratory Pressure During Elective Caesarean Section under Spinal Anaesthesia on Foetus 
Background:
It is known fact that pre-oxygenation with positive end-expiratory pressure (PEEP) improves the Partial pressure of oxygen (PO 2). In this regard not many studies have been done in pregnant women to know its effect on foetus. In this randomised double blind controlled study, we analysed effect of pre-oxygenation with PEEP during caesarean section on foetal umbilical venous PO 2.
Patients & Methods:
40 term pregnant women, ASA I or II, undergoing elective Caesarean section under spinal anaes-thesia were randomly divided into PEEP and Non-PEEP groups of 20 each. PEEP group received oxygen flow of 6 L/minute with PEEP of 5 cmH 2O using a modified Mapleson A circuit with fixed unidirectional PEEP valve at the expiratory port during pre-oxygenation and Non PEEP group received same fresh gas flow of oxygen using same breathing circuit without PEEP. Maternal arterial blood samples were collected before applying PEEP and at the end of 5 minutes of facemask application for oxygen analysis. Immediately after baby was delivered umbilical venous samples were taken for blood gas analysis.
Results:
Both groups were comparable in terms of maternal baseline oxygen saturation (Spo 2) and base line Po 2. After 5 minutes PO 2was higher in PEEP Group than non PEEP group (491.65 + 49.96 vs. 452.08 + 77.61). Umbilical venous Po 2in PEEP group was higher than non PEEP group (34.22 + 6.50 vs. 28.29 + 6.10 mm of Hg).
Conclusion:
Application of PEEP during pre-oxygenation for spinal anaesthesia can increase foetal umbilical venous PO2.
PMCID: PMC3087266  PMID: 21547172
Pre-oxygenation; Positive end-expiratory pressure; Caesarean section; Foetus
14.  Portrayal of caesarean section in Brazilian women’s magazines: 20 year review 
Objective To assess the quality and comprehensiveness of the information on caesarean section provided in Brazilian women’s magazines.
Design Review of articles published during 1988-2008 in top selling women’s magazines.
Setting Brazil, one of the countries with the highest caesarean section rates in the world.
Data sources Women’s magazines with the largest distribution during the study period, identified through the official national media indexing organisations.
Selection criteria Articles with objective scientific information or advice, comments, opinions, or the experience of ordinary women or celebrities on delivery by caesarean section.
Main outcome measures Sources of information mentioned by the author of the article, the accuracy and completeness of data presented on caesarean section, and alleged reasons why women would prefer to deliver though caesarean section.
Results 118 articles were included. The main cited sources of information were health professionals (78% (n=92) of the articles). 71% (n=84) of the articles reported at least one benefit of caesarean section, and 82% (n=97) reported at least one short term maternal risk of caesarean section. The benefits most often attributed to delivery by caesarean section were reduction of pain and convenience for family or health professionals. The most frequently reported short term maternal risks of caesarean section were increased time to recover and that it is a less natural way of giving birth. Only one third of the articles mentioned any long term maternal risks or perinatal complications associated with caesarean section. Fear of pain was the main reported reason why women would prefer to deliver by caesarean section.
Conclusions Most of the articles published in Brazilian women’s magazines do not use optimal sources of information. The portrayal of caesarean section is mostly balanced, not explicitly in favour of one or another route of delivery, but incomplete and may be leading women to underestimate the maternal/perinatal risks associated with this route of delivery.
doi:10.1136/bmj.d276
PMCID: PMC3026601  PMID: 21266421
15.  Awareness and Perceptions of and Attitudes towards Caesarean Delivery among Antenatal 
Ghana Medical Journal  2008;42(4):137-140.
Summary
Background
Caesarean section (CS) rates have been increasing steadily globally. The safety of the procedure has resulted in some women requesting it in the absence of any medical indication, particularly in the developed countries.
Objectives
To determine the awareness and perceptions of and attitudes towards caesarean delivery among antenatal clinic (ANC) attendants in a Ghanaian teaching hospital.
Design
Descriptive cross-sectional study.
Setting
The ANC of the Komfo Anokye Teaching Hospital (KATH), Kumasi, Ghana.
Methods
A 13-point structured questionnaire containing items on demographic characteristics and assessment of knowledge of, perceptions and attitudes towards caesarean delivery was administered to women attending the hospital's antenatal clinic from 1st December to 31st December, 2006.
Results
Of 317 women interviewed 304 (96%) had heard of the operation; however only 43 (13.5%) could mention specific indications for it. Vaginal delivery was preferred by 296 (93.3%) while 11 (3.5%) preferred planned caesarean delivery; the remaining 10 (3.2%) were undecided. Although 164 (51.7%) perceived it as being dangerous to the mother and baby, 287 (90.5%) were willing to undergo the operation when indicated; 19 (6%) would refuse the operation even when indicated. Almost all the women, 311 (98.1%), wanted caesarean section to be part of client education at the antenatal clinic and 314 (99.1%) wanted to be informed about the specific indication before surgery.
Conclusion
There is a high level of awareness of caesarean delivery among ANC attendants at the Komfo Anokye Teaching Hospital. Client education is necessary to address some concerns on safety of and indications for the operation.
PMCID: PMC2673831  PMID: 19452020
Caesarean section; awareness; perceptions; attitudes; Komfo Anokye Teaching Hospital
16.  Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial 
BMJ : British Medical Journal  2005;331(7518):662.
Objective To test whether steroids reduce respiratory distress in babies born by elective caesarean section at term.
Design Multicentre pragmatic randomised trial.
Setting 10 maternity units.
Participants 998 consenting women randomised at decision to deliver by elective caesarean section; 503 randomised to treatment group.
Interventions The treatment group received two intramuscular doses of 12 mg betamethasone in the 48 hours before delivery. The control group received treatment as usual.
Outcome measures The primary outcome was admission to special care baby unit with respiratory distress. Secondary outcomes were severity of respiratory distress and level of care in response.
Results Sex, birth weight, and gestation were not different between the two groups. Of the 35 babies admitted to special baby units with respiratory distress, 24 were in the control group and 11 in the intervention group (P = 0.02). The incidence of admission with respiratory distress was 0.051 in the control group and 0.024 in the treatment group (relative risk 0.46, 95% confidence interval 0.23 to 0.93). The incidence of transient tachypnoea of the newborn was 0.040 in the control group and 0.021 in the treatment group (0.54, 0.26 to 1.12). The incidence of respiratory distress syndrome was 0.011 in the control group and 0.002 in the treatment group (0.21, 0.03 to 1.32).
Conclusions Antenatal betamethasone and delaying delivery until 39 weeks both reduce admissions to special care baby units with respiratory distress after elective caesarean section at term.
doi:10.1136/bmj.38547.416493.06
PMCID: PMC1226243  PMID: 16115831
17.  Effect on survey response rate of hand written versus printed signature on a covering letter: randomised controlled trial [ISRCTN67566265] 
Background
It is important that response rates to postal surveys are as high as possible to ensure that the results are representative and to maximise statistical power. Previous research has suggested that any personalisation of approach helps to improve the response rate. This experiment tested whether personalising questionnaires by hand signing the covering letter improved the response rate compared with a non-personalised group where the investigator's signature on the covering letter was scanned into the document and printed.
Methods
Randomised controlled trial. Questionnaires about surgical techniques of caesarean section were mailed to 3,799 Members and Fellows of the Royal College of Obstetricians and Gynaecologists resident in the UK. Individuals were randomly allocated to receive a covering letter with either a computer printed signature or a hand written signature. Two reminders were sent to non-respondents. The outcome measures were the proportion of questionnaires returned and their time to return.
Results
The response rate was 79.1% (1506/1905) in the hand-signed group and 78.4% (1484/1894) in the scanned and printed signature group. There was no detectable difference between the groups in response rate or time taken to respond.
Conclusion
No advantage was detected to hand signing the covering letter accompanying a postal questionnaire to health professionals.
doi:10.1186/1472-6963-5-52
PMCID: PMC1190172  PMID: 16091137
18.  Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial  
BMJ : British Medical Journal  2007;334(7607):1305.
Objectives To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section.
Design Randomised trial, conducted from May 2004 to August 2006.
Setting Four maternity units in south west England, and Scotland.
Participants 742 pregnant women with one previous lower segment caesarean section and delivery expected at ≥37 weeks. Non-English speakers were excluded.
Interventions Usual care: standard care given by obstetric and midwifery staff. Information programme: women navigated through descriptions and probabilities of clinical outcomes for mother and baby associated with planned vaginal birth, elective caesarean section, and emergency caesarean section. Decision analysis: mode of delivery was recommended based on utility assessments performed by the woman combined with probabilities of clinical outcomes within a concealed decision tree. Both interventions were delivered via a laptop computer after brief instructions from a researcher.
Main outcome measures Total score on decisional conflict scale, and mode of delivery.
Results Women in the information programme (adjusted difference −6.2, 95% confidence interval −8.7 to −3.7) and the decision analysis (−4.0, −6.5 to −1.5) groups had reduced decisional conflict compared with women in the usual care group. The rate of vaginal birth was higher for women in the decision analysis group compared with the usual care group (37% v 30%, adjusted odds ratio 1.42, 0.94 to 2.14), but the rates were similar in the information programme and usual care groups.
Conclusions Decision aids can help women who have had a previous caesarean section to decide on mode of delivery in a subsequent pregnancy. The decision analysis approach might substantially affect national rates of caesarean section.
Trial Registration Current Controlled Trials ISRCTN84367722.
doi:10.1136/bmj.39217.671019.55
PMCID: PMC1895676  PMID: 17540908
19.  Active management of labour: current knowledge and research issues. 
BMJ : British Medical Journal  1994;309(6951):366-369.
OBJECTIVES--To review the evidence that the package of labour interventions collectively called "active management"--namely, strict diagnostic criteria for labour, early amniotomy, early use of oxytocin, and continuous professional support--reduce rates of caesarean sections and operative vaginal delivery in first labours. DESIGN--Review of observational data, supplemented by evidence from four separate overviews of relevant randomised trials previously published as part of the Cochrane Collaboration pregnancy and childbirth database. RESULTS--Observational data do not permit a clear conclusion. There have been no randomised trials of the total package of active management or of the use of strict diagnostic criteria alone, but trials of early amniotomy, early oxytocin, and these interventions combined do not suggest that these interventions are effective in reducing rates of caesarean sections or operative vaginal deliveries. In contrast, the provision of continuous professional support in labour seems to reduce both types of operative delivery, although the effect on caesarean sections is confined to those settings where non-professional companions are not normally present in labour. CONCLUSIONS--Delivery units should endeavour to provide continuous professional support in labour, but routine use of amniotomy and early oxytocin is not recommended.
PMCID: PMC2541231  PMID: 8081133
20.  The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies 
Bjog  2011;118(5):564-577.
Objective
To investigate whether initiating external cephalic version (ECV) earlier in pregnancy might increase the rate of successful ECV procedures, and be more effective in decreasing the rate of non-cephalic presentation at birth and of caesarean section.
Design
An unblinded multicentred randomised controlled trial.
Setting
A total of 1543 women were randomised from 68 centres in 21 countries.
Population
Women with a singleton breech fetus at a gestational age of 330/7 weeks (231 days) to 356/7 weeks (251 days) of gestation were included.
Methods
Participants were randomly assigned to having a first ECV procedure between the gestational ages of 340/7 (238 days) and 356/7 weeks of gestation (early ECV group) or at or after 370/7 (259 days) weeks of gestation (delayed ECV group).
Main outcome measures
The primary outcome was the rate of caesarean section; the secondary outcome was the rate of preterm birth.
Results
Fewer fetuses were in a non-cephalic presentation at birth in the early ECV group (314/765 [41.1%] versus 377/768 [49.1%] in the delayed ECV group; relative risk [RR] 0.84, 95% CI 0.75, 0.94, P = 0.002). There were no differences in rates of caesarean section (398/765 [52.0%] versus 430/768 [56.0%]; RR 0.93, 95% CI 0.85, 1.02, P = 0.12) or in risk of preterm birth (50/765 [6.5%] versus 34/768 [4.4%]; RR 1.48, 95% CI 0.97, 2.26, P = 0.07) between groups.
Conclusion
External cephalic version at 34–35 weeks versus 37 or more weeks of gestation increases the likelihood of cephalic presentation at birth but does not reduce the rate of caesarean section and may increase the rate of preterm birth.
doi:10.1111/j.1471-0528.2010.02837.x
PMCID: PMC3085121  PMID: 21291506
Breech pregnancy; caesarean section; external cephalic version; fetal version; randomised controlled trial
21.  Oral misoprostol for induction of labour at term: randomised controlled trial 
BMJ : British Medical Journal  2006;332(7540):509-513.
Objective To compare oral misoprostol solution with vaginal prostaglandin gel (dinoprostone) for induction of labour at term to determine whether misoprostol is superior.
Design Randomised double blind placebo controlled trial.
Setting Maternity departments in three hospitals in Australia.
Population Pregnant women with a singleton cephalic presentation at ≥ 36+6 weeks' gestation, with an indication for prostaglandin induction of labour.
Interventions 20 μg oral misoprostol solution at ourly intervals and placebo vaginal gel or vaginal dinoprostone gel at six hourly intervals and placebo oral solution.
Main outcome measures Vaginal birth within 24 hours; uterine hyperstimulation with associated changes in fetal heart rate; caesarean section (all); and caesarean section for fetal distress.
Results 741 women were randomised, 365 to the misoprostol group and 376 to the vaginal dinoprostone group. There were no significant differences between the two treatment groups in the primary outcomes: vaginal birth not achieved in 24 hours (misoprostol 168/365 (46.0%) v dinoprostone 155/376 (41.2%); relative risk 1.12, 95% confidence interval 0.95 to 1.32; P = 0.134), caesarean section (83/365 (22.7%) v 100/376 (26.6%); 0.82, 0.64 to 1.06; P = 0.127), caesarean section for fetal distress (32/365 (8.8%) v 35/376 (9.3%); 0.91, 0.57 to 1.44; P = 0.679), or uterine hyperstimulation with changes in fetal heart rate (3/365 (0.8%) v 6/376 (1.6%); 0.55, 0.14 to 2.21; P = 0.401). Although there were differences in the process of labour induction, there were no significant differences in adverse maternal or neonatal outcomes.
Conclusions This trial shows no evidence that oral misoprostol is superior to vaginal dinoprostone for induction of labour. However, it does not lead to poorer health outcomes for women or their infants, and oral treatment is preferred by women.
Trial registration National Health and Medical Research Council, Perinatal Trials, PT0361.
doi:10.1136/bmj.38729.513819.63
PMCID: PMC1388124  PMID: 16455695
22.  Caesarean section in four South East Asian countries: reasons for, rates, associated care practices and health outcomes 
Background
Caesarean section is a commonly performed operation on women that is globally increasing in prevalence each year. There is a large variation in the rates of caesarean, both in high and low income countries, as well as between different institutions within these countries. This audit aimed to report rates and reasons for caesarean and associated clinical care practices amongst nine hospitals in the four South East Asian countries participating in the South East Asia-Optimising Reproductive and Child Health in Developing countries (SEA-ORCHID) project.
Methods
Data on caesarean rates, care practices and health outcomes were collected from the medical records of the 9550 women and their 9665 infants admitted to the nine participating hospitals across South East Asia between January and December 2005.
Results
Overall 27% of women had a caesarean section, with rates varying from 19% to 35% between countries and 12% to 39% between hospitals within countries. The most common indications for caesarean were previous caesarean (7.0%), cephalopelvic disproportion (6.3%), malpresentation (4.7%) and fetal distress (3.3%). Neonatal resuscitation rates ranged from 7% to 60% between countries. Prophylactic antibiotics were almost universally given but variations in timing occurred between countries and between hospitals within countries.
Conclusion
Rates and reasons for caesarean section and associated clinical care practices and health outcomes varied widely between the four South East Asian countries.
doi:10.1186/1471-2393-9-17
PMCID: PMC2695422  PMID: 19426513
23.  Rates of caesarean section and instrumental vaginal delivery in nulliparous women after low concentration epidural infusions or opioid analgesia: systematic review 
BMJ : British Medical Journal  2004;328(7453):1410.
Objective To compare the effects of low concentration epidural infusions of bupivacaine with parenteral opioid analgesia on rates of caesarean section and instrumental vaginal delivery in nulliparous women.
Data sources Medline, Embase, the Cochrane controlled trials register, and handsearching of the International Journal of Obstetric Anesthesia.
Study selection Randomised controlled trials comparing low concentration epidural infusions with parenteral opioids.
Data synthesis Seven trials fulfilled the inclusion criteria for meta-analysis. Epidural analgesia does not seem to be associated with an increased risk of caesarean section (odds ratio 1.03, 95% confidence interval 0.71 to 1.48) but may be associated with an increased risk of instrumental vaginal delivery (2.11, 0.95 to 4.65). Epidural analgesia was associated with a longer second stage of labour (weighted mean difference 15.2 minutes, 2.1 to 28.2 minutes). More women randomised to receive epidural analgesia had adequate pain relief, with fewer changing to parenteral opioids than vice versa (odds ratio 0.1, 0.05 to 0.22).
Conclusions Epidural analgesia using low concentration infusions of bupivacaine is unlikely to increase the risk of caesarean section but may increase the risk of instrumental vaginal delivery. Although women receiving epidural analgesia had a longer second stage of labour, they had better pain relief.
doi:10.1136/bmj.38097.590810.7C
PMCID: PMC421779  PMID: 15169744
24.  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
25.  COSMOS: COmparing Standard Maternity care with One-to-one midwifery Support: a randomised controlled trial 
Background
In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6–12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail.
Methods/design
A two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self administered survey) and at 2 and 6 months postpartum by postal survey. Medical/obstetric outcomes will be abstracted from the medical record. The sample size of 2008 was calculated to identify a decrease in caesarean birth from 19 to 14% and detect a range of other significant clinical differences. Comprehensive process and economic evaluations will be conducted.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN012607000073404.
doi:10.1186/1471-2393-8-35
PMCID: PMC2526977  PMID: 18680606

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