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1.  Rate of spontaneous onset of labour before planned repeat caesarean section at term 
Guidelines recommend that, in the absence of compelling medical indications (low risk) elective caesarean section should occur after 38 completed weeks gestation. However, implementation of these guidelines will mean some women go into labour before the planned date resulting in an intrapartum caesarean section. The aim of this study was to determine the rate at which low-risk women planned for repeat caesarean section go into spontaneous labour before 39 weeks.
We conducted a population-based cohort study of women who were planned to have an elective repeat caesarean section (ERCS) at 39-41 weeks gestation in New South Wales Australia, 2007-2010. Labour, delivery and health outcome information was obtained from linked birth and hospital records for the entire population. Women with no pre-existing medical or pregnancy complications were categorized as ‘low risk’. The rate of spontaneous labour before 39 weeks was determined and variation in the rate for subgroups of women was examined using univariate and multivariate analysis.
Of 32,934 women who had ERCS as the reported indication for caesarean section, 17,314 (52.6%) were categorised as ‘low-risk’. Of these women, 1,473 (8.5% or 1 in 12) had spontaneous labour or prelabour rupture of the membranes before 39 weeks resulting in an intrapartum caesarean section. However the risk of labour <39 weeks varied depending on previous delivery history: 25% (1 in 4) for those with spontaneous preterm labour in a prior pregnancy; 15% (1 in 7) for women with a prior planned preterm birth (by labour induction or prelabour caesarean) and 6% (1 in 17) among those who had only previously had a planned caesarean section at term. Smoking in pregnancy was also associated with spontaneous labour. Women with spontaneous labour prior to a planned CS in the index pregnancy were at increased risk of out-of-hours delivery, and maternal and neonatal morbidity.
These findings allow clinicians to more accurately determine the likelihood that a planned caesarean section may become an intrapartum caesarean section, and to advise their patients accordingly.
PMCID: PMC3975468  PMID: 24694261
Cohort study; Elective repeat caesarean section; Labour; Record linkage
2.  Women with gestational diabetes in Vietnam: a qualitative study to determine attitudes and health behaviours 
Diabetes is increasing in prevalence globally, notably amongst populations from low- and middle- income countries. Gestational Diabetes Mellitus(GDM), a precursor for type 2 diabetes, is increasing in line with this trend. Few studies have considered the personal and social effects of GDM on women living in low and middle-income countries. The aim of this study was determine attitudes and health behaviours of pregnant women with GDM in Vietnam.
This was a qualitative study using focus group methodology conducted in Ho Chi Minh City. Pregnant women, aged over 18 years, with GDM were eligible to participate. Women were purposely sampled to obtain a range of gestational ages and severity of disease. They were invited to attend a 1-hour focus group. Questions were semi structured around six themes. Focus groups were recorded, transcribed, translated and cross-referenced. Non-verbal and group interactions were recorded. Thematic analysis was performed using a theoretical framework approach.
From December 2010 to February 2011, four focus groups were conducted involving 34 women. Median age was 31.5 years (range 23 to 44), median BMI 21.8 kg/m2. Women felt confusion, anxiety and guilt about GDM. Many perceived their baby to be at increased risk of death. Advice to reduce dietary starch was confusing. Women reported being ‘hungry’ or ‘starving’ most of the time, unaware of appropriate food substitutions. They were concerned about transmission of GDM through breast milk. Several women planned not to breastfeed. All felt they needed more information. Current sources of information included friends, magazines, a health phone line or the Internet. Women felt small group sessions and information leaflets could benefit them.
This study highlights the need for culturally appropriate clinical education and health promotion activities for women with GDM in Vietnam.
PMCID: PMC3449178  PMID: 22873351
Gestational diabetes; Women; Vietnam; Developing countries; Focus group; Qualitative research; Pregnancy complications; Health promotion; Diabetes education
3.  Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077] 
Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases.
Using a prospective, randomised, open-label, blinded-endpoint (PROBE) study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care <20 weeks gestation with singleton pregnancies are eligible for inclusion. The intervention is a 6-day course of clotrimazole vaginal pessaries (100 mg) and the primary outcome is spontaneous preterm birth <37 weeks gestation.
The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone) to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care). Outcomes will be obtained from population databases.
A sample size of 3,208 women with Candida colonisation (1,604 per arm) is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8). Analyses will be by intention to treat.
For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design.
This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in pregnancy significantly reduces the rate of spontaneous preterm birth. If it can be demonstrated that treating asymptomatic candidiasis reduces preterm births this will change current practice and would directly impact the management of every pregnant woman.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12610000607077
PMCID: PMC3061957  PMID: 21396091
4.  Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial 
Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth.
We used a prospective, randomized, open-label, blinded-endpoint (PROBE) study design. Pregnant women presenting at <20 weeks gestation with singleton pregnancies self-collected a vaginal swab. Those who were asymptomatic and culture positive for Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg) or usual care (screening result is not revealed, no treatment). The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth <37 weeks gestation was also assessed.
Of 779 women approached, 500 (64%) participated in candidiasis screening, and 98 (19.6%) had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03.
A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052224
PMCID: PMC3063235  PMID: 21396090
5.  Epidemiology and trends for Caesarean section births in New South Wales, Australia: A population-based study 
Caesarean section (CS) rates around the world have been increasing and in Australia have reached 30% of all births. Robson's Ten-Group Classification System (10-group classification) provides a clinically relevant classification of CS rates that provides a useful basis for international comparisons and trend analyses. This study aimed to investigate trends in CS rates in New South Wales (NSW), including trends in the components of the 10-group classification.
We undertook a cross-sectional study using data from the Midwives Data Collection, a state-wide surveillance system that monitors patterns of pregnancy care, services and pregnancy outcomes in New South Wales, Australia. The study population included all women giving birth between 1st January 1998 and 31st December 2008. Descriptive statistics are presented including age-standardised CS rates, annual percentage change as well as regression analyses.
From 1998 to 2008 the CS rate in NSW increased from 19.1 to 29.5 per 100 births. There was a significant average annual increase in primary 4.3% (95%CI 3.0-5.7%) and repeat 4.8% (95% CI 3.9-5.7%) CS rates from 1998 to 2008. After adjusting for maternal and pregnancy factors, the increase in CS delivery over time was maintained. When examining CS rates classified according to the 10-group classification, the greatest contributors to the overall CS rate and the largest annual increases occurred among nulliparae at term having elective CS and multipara having elective repeat CS.
Given that the increased CS rate cannot be explained by known and collected maternal or pregnancy characteristics, the increase may be related to differences in clinical decision making or maternal request. Future efforts to reduce the overall CS rate should be focussed on reducing the primary CS rate.
PMCID: PMC3037931  PMID: 21251270
6.  Trends in adverse maternal outcomes during childbirth: a population-based study of severe maternal morbidity 
Maternal mortality is too rare in high income countries to be used as a marker of the quality of maternity care. Consequently severe maternal morbidity has been suggested as a better indicator. Using the maternal morbidity outcome indicator (MMOI) developed and validated for use in routinely collected population health data, we aimed to determine trends in severe adverse maternal outcomes during the birth admission and in particular to examine the contribution of postpartum haemorrhage (PPH).
We applied the MMOI to the linked birth-hospital discharge records for all women who gave birth in New South Wales, Australia from 1999 to 2004 and determined rates of severe adverse maternal outcomes. We used frequency distributions and contingency table analyses to examine the association between adverse outcomes and maternal, pregnancy and birth characteristics, among all women and among only those with PPH. Using logistic regression, we modelled the effects of these characteristics on adverse maternal outcomes. The impact of adverse outcomes on duration of hospital admission was also examined.
Of 500,603 women with linked birth and hospital records, 6242 (12.5 per 1,000) suffered an adverse outcome, including 22 who died. The rate of adverse maternal outcomes increased from 11.5 in 1999 to 13.8 per 1000 deliveries in 2004, an annual increase of 3.8% (95%CI 2.3–5.3%). This increase occurred almost entirely among women with a PPH. Changes in pregnancy and birth factors during the study period did not account for increases in adverse outcomes either overall, or among the subgroup of women with PPH. Among women with severe adverse outcomes there was a 12% decrease in hospital days over the study period, whereas women with no severe adverse outcome occupied 23% fewer hospital days in 2004 than in 1999.
Severe adverse maternal outcomes associated with childbirth have increased in Australia and the increase was entirely among women who experienced a PPH. Reducing or stabilising PPH rates would halt the increase in adverse maternal outcomes.
PMCID: PMC2653462  PMID: 19243578
7.  Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT) Trial [ISRCTN44485060] 
Preterm prelabour rupture of membranes (PPROM) complicates up to 2% of all pregnancies and is the cause of 40% of all preterm births. The optimal management of women with PPROM prior to 37 weeks, is not known. Furthermore, diversity in current clinical practice suggests uncertainty about the appropriate clinical management.
There are two options for managing PPROM, expectant management (a wait and see approach) or early planned birth. Infection is the main risk for women in which management is expectant. This risk need to be balanced against the risk of iatrogenic prematurity if early delivery is planned. The different treatment options may also have different health care costs. Expectant management results in prolonged antenatal hospitalisation while planned early delivery may necessitate intensive care of the neonate for problems associated with prematurity.
We aim to evaluate the effectiveness of early planned birth compared with expectant management for women with PPROM between 34 weeks and 366 weeks gestation, in a randomised controlled trial. A secondary aim is a cost analysis to establish the economic impact of the two treatment options and establish the treatment preferences of women with PPROM close to term.
The early planned birth group will be delivered within 24 hours according to local management protocols. In the expectant management group birth will occur after spontaneous labour, at term or when the attending clinician feels that birth is indicated according to usual care. Approximately 1812 women with PPROM at 34–366 weeks gestation will be recruited for the trial.
The primary outcome of the study is neonatal sepsis. Secondary infant outcomes include respiratory distress, perinatal mortality, neonatal intensive care unit admission, assisted ventilation and early infant development. Secondary maternal outcomes include chorioamnionitis, postpartum infection treated with antibiotics, antepartum haemorrhage, induction of labour, mode of delivery, maternal satisfaction with care, duration of hospitalisation, and maternal wellbeing at four months postpartum.
This trial will provide evidence on the optimal care for women with PPROM close to term (34–37 weeks gestation). Consideration of both the clinical and economic sequelae of the management of PPROM will enable informed decision making and guideline development.
PMCID: PMC1464097  PMID: 16556323

Results 1-7 (7)