My Baby's Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths.

OBJECTIVE: The My Baby's Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (the MBM intervention). DESIGN: Stepped-wedge cluster-randomised controlled trial. SETTING: Twenty-seven maternity hospitals in Australia and New Zealand. POPULATION: Women with a singleton pregnancy without major fetal anomaly at ≥28 weeks of gestation from August 2016 to May 2019. METHODS: The MBM intervention was implemented at randomly assigned time points, with the sequential introduction of eight groups of between three and five hospitals at 4-monthly intervals. Using generalised linear mixed models, the stillbirth rate was compared in the control and the intervention periods, adjusting for calendar time, study population characteristics and hospital effects. MAIN OUTCOME MEASURES: Stillbirth at ≥28 weeks of gestation. RESULTS: There were 304 850 births with 290 105 births meeting the inclusion criteria: 150 053 in the control and 140 052 in the intervention periods. The stillbirth rate was lower (although not statistically significantly so) during the intervention compared with the control period (2.2/1000 versus 2.4/1000 births; aOR 1.18, 95% CI 0.93-1.50; P = 0.18). The decrease in stillbirth rate was greater across calendar time: 2.7/1000 in the first versus 2.0/1000 in the last 18 months. No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. CONCLUSIONS: The MBM intervention did not reduce stillbirths beyond the downward trend over time. As a result of low uptake, the role of the intervention remains unclear, although the downward trend across time suggests some benefit in lowering the stillbirth rate. In this study setting, an awareness of the importance of fetal movements may have reached pregnant women and clinicians prior to the implementation of the intervention. TWEETABLE ABSTRACT: The My Baby's Movements intervention to raise awareness of decreased fetal movement did not significantly reduce stillbirth rates.

A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.

OBJECTIVE: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). DESIGN: A consensus developmental study. SETTING: International. POPULATION: Two hundred and five stakeholders completed the first round. METHODS: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. MAIN OUTCOME MEASURES: All outcomes were extracted from the literature. RESULTS: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. CONCLUSIONS: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. TWEETABLE ABSTRACT: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.

My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.

BACKGROUND: Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates. METHODS/DESIGN: This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models. DISCUSSION: Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app. TRIAL REGISTRATION: ACTRN12614000291684. Registered 19 March 2014. VERSION: Protocol Version 6.1, February 2018.

Identifying the barriers and enablers in the implementation of the New Zealand and Australian Antenatal Corticosteroid Clinical Practice Guidelines.

BACKGROUND: The ineffective implementation of evidence based practice guidelines can mean that the best health outcomes are not achieved. This study examined the barriers and enablers to the uptake and implementation of the new bi-national (Australia and New Zealand) antenatal corticosteroid clinical practice guidelines among health professionals, using the Theoretical Domains Framework. METHODS: Semi-structured interviews or online questionnaires were conducted across four health professional groups and three district health boards in Auckland, New Zealand. The questions were constructed to reflect the 14 behavioural domains from the Theoretical Domains Framework. Relevant domains were identified by the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour using thematic analysis. The influence of health professional group and organisation on the different barriers and enablers identified were explored. RESULTS: Seventy-three health professionals completed either a semi-structured interview (n = 35) or on-line questionnaire (n = 38). Seven behavioural domains were identified as overarching enablers: belief about consequences; knowledge; social influences; environmental context and resource; belief about capabilities; social professional role and identity; and behavioural regulation. Five behavioural domains were identified as overarching barriers: environmental context and resources; knowledge; social influences; belief about consequences; and social professional role and identity. Differences in beliefs between individual health professional groups were identified within the domains: belief about consequences; social professional role and identity; and emotion. Organisational differences were identified within the domains: belief about consequences; social influences; and belief about capabilities. CONCLUSION: This study has identified some of the enablers and barriers to implementation of the New Zealand and Australian Antenatal Corticosteroid Clinical Practice Guidelines using the validated Theoretical Domains Framework, as perceived by health professionals. We have identified differences between individual health professional groups and organisations. The identification of these behavioural determinants can be used to enhance an implementation strategy, assist in the design of interventions to achieve improved implementation and facilitate process evaluations to understand why or how change interventions are effective.

Consumers attitudes and beliefs towards the receipt of antenatal corticosteroids and use of clinical practice guidelines.

BACKGROUND: Active participation of consumers in health care decision making, policy and clinical research is increasingly encouraged by governments, influential bodies and funders. Identifying the best way to achieve this is difficult due to the paucity of evidence. Consumers have mixed feelings towards clinical practice guidelines (CPG) demonstrating scepticism towards their purpose and applicability to their needs. There is no information pertaining to consumers' views and attitudes on the receipt of antenatal corticosteroids (ACS). The aim of this study was to examine the barriers and enablers to receiving ACS and use of CPG amongst consumers. METHODS: Consumers were recruited from neonatal units across three district health boards (DHBs) in Auckland, New Zealand. Participants completed a semi-structured interview or questionnaire. The questions posed and analyses were informed by the Theoretical Domains Framework (TDF). Barriers and enablers were identified by the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on use of CPG and receipt of ACS. RESULTS: Twenty four consumers participated in the study. Six domains were identified as barriers to receipt of ACS and use of CPG. Key barriers to receipt of ACS included: difficulty retaining information conveyed, requiring further information in a variety of formats, and time constraints faced by consumers and health professionals in the provision and understanding of information to facilitate decision making. Barriers to use of CPG included: uncertainty about applicability of guideline use among consumers and scepticism about health professionals adhering too rigidly to guidelines. Enablers to receipt of ACS included: optimism toward ACS use, a strong knowledge of why ACS were administered, improved resilience in their pregnancy and confidence in their decision making following receipt of information about ACS. Enablers to use of CPG included: validation and standardisation of decision making among health professionals providing care and facilitating the best care for women and their babies. CONCLUSIONS: Key barriers and enablers exist among consumers regarding receipt of ACS and use of CPG. These need to be addressed or modified in any intervention strategy to facilitate implementation of the ACS CPG.

Antenatal dietary and lifestyle advice for women who are overweight or obese and the effect on fetal growth and adiposity: the LIMIT randomised trial.

OBJECTIVE: To report the influence of maternal overweight and obesity on fetal growth and adiposity and effects of an antenatal dietary and lifestyle intervention among these women on measures of fetal growth and adiposity as secondary outcomes of the LIMIT Trial. DESIGN: Randomised controlled trial. SETTING: Public maternity hospitals in metropolitan Adelaide, South Australia. POPULATION: Pregnant women with a body mass index ≥ 25 kg/m(2), and singleton gestation between 10(+0) and 20(+0) weeks. METHODS: Women were randomised to Lifestyle Advice or continued Standard Care and offered two research ultrasound scans at 28 and 36 weeks of gestation. MAIN OUTCOME MEASURES: Ultrasound measures of fetal growth and adiposity. RESULTS: For each fetal body composition parameter, mean Z-scores were substantially higher when compared with population standards. Fetuses of women receiving Lifestyle Advice demonstrated significantly greater mean mid-thigh fat mass, when compared with fetuses of women receiving Standard Care (adjusted difference in means 0.17; 95% CI 0.02-0.32; P = 0.0245). While subscapular fat mass increased between 28 and 36 weeks of gestation in fetuses in both treatment groups, the rate of adipose tissue deposition slowed among fetuses of women receiving Lifestyle Advice, when compared with fetuses of women receiving Standard Care (P = 0.0160). No other significant differences were observed. CONCLUSIONS: These findings provide the first evidence of changes to fetal growth following an antenatal dietary and lifestyle intervention among women who are overweight or obese.

Women's views on postpartum testing for type 2 diabetes after gestational diabetes: Six month follow-up to the DIAMIND randomised controlled trial.

BACKGROUND: This study assessed the views of the women who participated in the DIAMIND randomised trial of postpartum SMS reminders to test for type 2 diabetes after gestational diabetes (GDM) on their preferred type of postpartum reminder system and barriers and facilitators to completion of postpartum diabetes testing. METHOD: A written questionnaire was sent to women with recent GDM who participated in the DIAMIND trial (n=276) via post or email at six months after the birth of their baby. RESULTS: 208 women (75%) returned the study questionnaires. Preferred postpartum reminder types were: SMS (67%), email (17%), postal (12%) and voice call (1%). Women who had not yet completed an OGTT indicated that they planned to undertake one in the future (61%). Common barriers to postpartum OGTT completion included: not having enough time (73%), inadequate childcare (30%), and a need to focus on the health of the baby (30%). The most common facilitator was having a shorter test (33%). CONCLUSIONS: Improved childcare quality and access as well as more research into a shorter, more convenient test procedure for type 2 diabetes screening are needed. Reminder systems for postpartum diabetes screening should be electronic where possible.

Postpartum SMS reminders to women who have experienced gestational diabetes to test for Type 2 diabetes: the DIAMIND randomized trial.

AIMS: This parallel group randomized controlled trial assessed whether an SMS reminder system for women, after gestational diabetes, would increase their attendance for an oral glucose tolerance test (OGTT) by six months postpartum. METHODS: Women were eligible for inclusion if they were diagnosed with gestational diabetes in their recent pregnancy, had a mobile phone and normal blood glucose profile prior to postnatal discharge from the Women's and Children's Hospital, Adelaide. A computer-generated random number sequence and telephone randomization were used. Two hundred and seventy-six women were randomized. Women in the six-week group (n = 140) were sent a text reminder to attend for an OGTT at six weeks postpartum, with further reminders at three and six months if required. Women in the control group (n = 136) received one text reminder at six months postpartum. Blinding was not feasible. The primary outcome was OGTT attendance within six months postpartum. RESULTS: Women in the six-week group did not increase their attendance for an OGTT within six months postpartum compared with women in the control group, 104 (77.6% of 134) versus 103 (76.8% of 134), relative risk (RR) 1.01, 95% confidence interval (CI) 0.89-1.15. CONCLUSIONS: The SMS reminder system did not increase postpartum OGTT, fasting plasma glucose or HbA1c completion, although high rates of test completion were measured in both groups. Further research is required into factors influencing attendance for postpartum testing from the perspective of women, and into optimal counselling relating to Type 2 diabetes risk in the postpartum period for increasing postpartum glucose testing rates.

Mode and timing of twin delivery and perinatal outcomes in low- and middle-income countries: a secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: To describe the mode and timing of delivery of twin pregnancies at ≥34 weeks of gestation and their association with perinatal outcomes. DESIGN: Secondary analysis of a cross-sectional study. POPULATION: Twin deliveries at ≥34 weeks of gestation from 21 low- and middle-income countries participating in the WHO Multicountry Survey on Maternal and Newborn Health. METHODS: Descriptive analysis and effect estimates using multilevel logistic regression. MAIN OUTCOME MEASURES: Stillbirth, perinatal mortality, and neonatal near miss (use of selected life saving interventions at birth). RESULTS: The average length of gestation at delivery was 37.6 weeks. Of all twin deliveries, 16.8 and 17.6% were delivered by caesarean section before and after the onset of labour, respectively. Prelabour caesarean delivery was associated with older maternal age, higher institutional capacity and wealth of the country. Compared with spontaneous vaginal delivery, lower risks of neonatal near miss (adjusted odds ratio, aOR, 0.63; 95% confidence interval, 95% CI, 0.44-0.94) were found among prelabour caesarean deliveries. A lower risk of early neonatal mortality (aOR 0.12; 95% CI 0.02-0.56) was also observed among prelabour caesarean deliveries with nonvertex presentation of the first twin. The week of gestation with the lowest rate of prospective fetal death varied by fetal presentation: 37 weeks for vertex-vertex; 39 weeks for vertex-nonvertex; and 38 weeks for a nonvertex first twin. CONCLUSIONS: The prelabour caesarean delivery rate among twins varied largely between countries, probably as a result of overuse of caesarean delivery in wealthier countries and limited access to caesarean delivery in low-income countries. Prelabour delivery may be beneficial when the first twin is nonvertex. International guidelines for optimal twin delivery methods are needed.

Maternal adverse effects with different loading infusion rates of antenatal magnesium sulphate for preterm fetal neuroprotection: the IRIS randomised trial.

OBJECTIVE: To evaluate a slower (compared with a standard) infusion rate of the loading dose of magnesium sulphate for preterm fetal neuroprotection as a strategy to reduce maternal adverse effects. DESIGN: Randomised controlled trial. SETTING: South Australian maternity hospital. POPULATION: Fifty-one women at <30 weeks of gestation, where birth was planned or expected within 24 hours. METHODS: Women received a loading infusion of 4 g of magnesium sulphate over either 60 or 20 minutes (followed by maintenance of 1 g/hour until birth, or for up to 24 hours). MAIN OUTCOME MEASURES: Any maternal adverse effects associated with the infusion. RESULTS: Overall, 71% of women experienced adverse effects during the first hour of their infusion; the difference between groups was not significant [15/25 (60%) 60-minute loading; 21/26 (81%) 20-minute loading; risk ratio (RR) 0.74; 95% confidence interval (95% CI) 0.51-1.08]. Although no serious maternal complications occurred, adverse effects led to three women ceasing the loading treatment (1/25 in the 60-minute loading group; 2/26 in the 20-minute loading group; RR 0.52; 95% CI 0.05-5.38). Women in the 60-minute loading group experienced significantly less warmth and flushing at 20 minutes into the infusion (7/25 in the 60-minute loading group; 15/26 in the 20-minute loading group; RR 0.49; 95% CI 0.24-0.99). No other differences between groups for maternally reported and clinical adverse effects were shown. CONCLUSIONS: A slower rate of administering the loading dose of magnesium sulphate did not reduce the occurrence of maternal adverse effects overall. Flushing and warmth at 20 minutes into the infusion was reduced with a slower infusion.

Hypnosis antenatal training for childbirth: a randomised controlled trial.

OBJECTIVE: To determine the use of pharmacologic analgesia during childbirth when antenatal hypnosis is added to standard care. DESIGN: Randomised controlled clinical trial, conducted from December 2005 to December 2010. SETTING: The largest tertiary referral centre for maternity care in South Australia. POPULATION: A cohort of 448 women at >34 weeks of gestation, with a singleton pregnancy and cephalic presentation, planning a vaginal birth. Exclusions were: the need for an interpreter; pre-existing pain; psychiatric illness; younger than 18 years; and previous experience of hypnosis for childbirth. METHODS: All participants received usual care. The group of women termed Hypnosis + CD (hypnotherapist guided) were offered three antenatal live hypnosis sessions plus each session's corresponding audio CD for further practise, as well as a final fourth CD to listen to during labour. The group of women termed CD only (nurse administered) were played the same antenatal hypnosis CDs as group 1, but did not receive live hypnosis training. The control group participants were given no additional intervention or CDs. MAIN OUTCOME MEASURE: Use of pharmacological analgesia during labour and childbirth. RESULTS: No difference in the use of pharmacological analgesia during labour and childbirth was found comparing hypnosis + CD with control (81.2 versus 76.2%; relative risk, RR 1.07; 95% confidence interval, 95% CI 0.95-1.20), or comparing CD only with control (76.9 versus 76.2%, RR 1.01, 95% CI 0.89-1.15). CONCLUSIONS: Antenatal group hypnosis using the Hypnosis Antenatal Training for Childbirth (HATCh) intervention in late pregnancy does not reduce the use of pharmacological analgesia during labour and childbirth.

Elective birth at 37 weeks of gestation versus standard care for women with an uncomplicated twin pregnancy at term: the Twins Timing of Birth Randomised Trial.

OBJECTIVE: To evaluate whether for women with an uncomplicated twin pregnancy, elective birth at 37 weeks of gestation was associated with reduced risk of death or serious outcomes for babies, without increasing harm. DESIGN: Randomised controlled trial. SETTING: Maternity hospitals across Australia, New Zealand and Italy. POPULATION: A total of 235 women with an uncomplicated twin pregnancy at 36(+6) weeks of gestation, with no contraindication to continuing their pregnancy. METHODS: Using a computer-generated, central telephone randomisation service, 235 women were randomised to Elective Birth (birth at 37 weeks; n=116) or Standard Care (continued expectant management, with birth planned from 38 weeks; n=119). Outcome assessors were masked to treatment allocation. MAIN OUTCOME MEASURE: A composite of serious adverse outcome for the infant. RESULTS: For women with an uncomplicated twin pregnancy, elective birth at 37 weeks of gestation was associated with a significant reduction in risk of serious adverse outcome for the infant (Elective Birth 11/232 [4.7%] versus Standard Care 29/238 [12.2%]; risk ratio [RR] 0.39; 95% CI 0.20-0.75; P=0.005), reflecting a reduction in birthweight less than the third centile using singleton gestational age-specific charts (Elective Birth 7/232 [3.0%] versus Standard Care 24/238 [10.1%]; RR 0.30; 95% CI 0.13-0.67; P=0.004). In a post hoc analysis using twin gestational age-specific charts, there was evidence of a trend towards a reduction in the primary composite of serious adverse infant outcome (Elective Birth Group 4/232 [1.7%] versus Standard Care Group 12/238 [5.0%]; RR 0.34; 95% CI 0.11 to 1.05; P=0.06). CONCLUSION: The findings of our study support recommendations for women with an uncomplicated twin pregnancy to birth at 37 weeks of gestation.

Impact of increasing capacity for generating and using research on maternal and perinatal health practices in South East Asia (SEA-ORCHID Project).

BACKGROUND: Maternal and neonatal mortality and morbidity remain unacceptably high in many low and middle income countries. SEA-ORCHID was a five year international collaborative project in South East Asia which aimed to determine whether health care and health outcomes for mothers and babies could be improved by developing capacity for research generation, synthesis and use. METHODS: Nine hospitals in Indonesia, Malaysia, the Philippines and Thailand participated in SEA-ORCHID. These hospitals were supported by researchers from three Australian centres. Health care practices and outcomes were assessed for 1000 women at each hospital both before and after the intervention. The capacity development intervention was tailored to the needs and context of each hospital and delivered over an 18 month period. Main outcomes included adherence to forms of care likely to be beneficial and avoidance of forms of care likely to be ineffective or harmful. RESULTS: We observed substantial variation in clinical practice change between sites. The capacity development intervention had a positive impact on some care practices across all countries, including increased family support during labour and decreased perineal shaving before birth, but in some areas there was no significant change in practice and a few beneficial practices were followed less often. CONCLUSION: The results of SEA-ORCHID demonstrate that investing in developing capacity for research use, synthesis and generation can lead to improvements in maternal and neonatal health practice and highlight the difficulty of implementing evidence-based practice change.

Antenatal interventions for overweight or obese pregnant women: a systematic review of randomised trials.

BACKGROUND: Overweight and obesity during pregnancy is an increasing health problem. OBJECTIVE: A systematic review to assess the benefits and harms of antenatal dietary or lifestyle interventions for pregnant women who are overweight or obese. SEARCH STRATEGY: The Cochrane Controlled Trials Register(CENTRAL) was searched (last search January 2010). Reference lists of retrieved studies were searched by hand. No date or language restrictions were used. SELECTION CRITERIA: Randomised controlled trials comparing antenatal dietary and/or lifestyle or other interventions with no treatment for overweight or obese women were considered.Studies were evaluated independently for appropriateness for inclusion and methodological quality. The primary outcome was large-for-gestational-age infants. DATA COLLECTION AND ANALYSIS: Nine randomised controlled trials were included involving 743 women who were overweight or obese during pregnancy. Seven trials compared a dietary intervention with standard antenatal care. MAIN RESULTS: There were no statistically significant differences identified between women who received an antenatal intervention and those who did not for the large-for-gestational-age infant outcome (three studies; 366 women; risk ratio 2.02; 95% CI 0.84,4.86) or mean gestational weight gain [four studies; 416 women;weighted mean difference )3.10 kg; 95% CI )8.32, 2.13 (random effects model)]. There were no statistically significant differences identified for other reported outcomes. AUTHOR'S CONCLUSIONS: The effect of providing an antenatal dietary intervention for overweight or obese pregnant women on maternal and infant health outcomes remains unclear.

Should we lower the dose of iron when treating anaemia in pregnancy? A randomized dose-response trial.

BACKGROUND/OBJECTIVES: To compare the efficacy and side effects of low-dose vs high-dose iron supplements to correct anaemia in pregnancy. SUBJECTS/METHODS: One hundred and eighty women with anaemia (haemoglobin <110 g l(-1)) in mid-pregnancy. The women were randomly allocated to 20; 40 or 80 mg of iron daily for 8 weeks from mid-pregnancy. RESULTS: One hundred and seventy-nine (99%) women completed the trial. At the end of treatment, there was a clear dose-response of increasing mean haemoglobin concentration with iron dose (111+/-13 g l(-1) at 20 mg per day, 114+/-11 g l(-1) at 40 mg per day and 119+/-12 g l(-1) at 80 mg per day, P=0.006). However, the incidence of anaemia did not differ statistically between groups. Compared with women in the 80 mg iron group, the odds ratio of anaemia was 1.9 (95% CI: 0.8, 4.3, P=0.130) and 1.1 (95% CI: 0.5, 2.6, P=0.827), respectively, for women in the 20 mg iron group and the 40 mg iron group. The incidence of gastrointestinal side effects was significantly lower for women in the 20 mg iron group compared with women in the 80 mg iron group; the odds ratio was 0.4 (95% CI: 0.2, 0.8, P=0.014) for nausea, 0.3 (95% CI: 0.2, 0.7, P=0.005) for stomach pain and 0.4 (95% CI: 0.2, 0.9, P=0.023) for vomiting. CONCLUSIONS: Low-dose iron supplements may be effective at treating anaemia in pregnancy with less gastrointestinal side effects compared with high-dose supplements.

Use of evidence-based practices in pregnancy and childbirth: South East Asia Optimising Reproductive and Child Health in Developing Countries project.

BACKGROUND: The burden of mortality and morbidity related to pregnancy and childbirth remains concentrated in developing countries. SEA-ORCHID (South East Asia Optimising Reproductive and Child Health In Developing countries) is evaluating whether a multifaceted intervention to strengthen capacity for research synthesis, evidence-based care and knowledge implementation improves adoption of best clinical practice recommendations leading to better health for mothers and babies. In this study we assessed current practices in perinatal health care in four South East Asian countries and determined whether they were aligned with best practice recommendations. METHODOLOGY/PRINCIPAL FINDINGS: We completed an audit of 9550 medical records of women and their 9665 infants at nine hospitals; two in each of Indonesia, Malaysia and The Philippines, and three in Thailand between January-December 2005. We compared actual clinical practices with best practice recommendations selected from the Cochrane Library and the World Health Organization Reproductive Health Library. Evidence-based components of the active management of the third stage of labour and appropriately treating eclampsia with magnesium sulphate were universally practiced in all hospitals. Appropriate antibiotic prophylaxis for caesarean section, a beneficial form of care, was practiced in less than 5% of cases in most hospitals. Use of the unnecessary practices of enema in labour ranged from 1% to 61% and rates of episiotomy for vaginal birth ranged from 31% to 95%. Other appropriate practices were commonly performed to varying degrees between countries and also between hospitals within the same country. CONCLUSIONS/SIGNIFICANCE: Whilst some perinatal health care practices audited were consistent with best available evidence, several were not. We conclude that recording of clinical practices should be an essential step to improve quality of care. Based on these findings, the SEA-ORCHID project team has been developing and implementing interventions aimed at increasing compliance with evidence-based clinical practice recommendations to improve perinatal practice in South East Asia.

Antioxidants for preventing pre-eclampsia.

BACKGROUND: Oxidative stress has been proposed as a key factor involved in the development of pre-eclampsia. Supplementing women with antioxidants during pregnancy may help to counteract oxidative stress and thereby prevent or delay the onset of pre-eclampsia. OBJECTIVES: To determine the effectiveness and safety of any antioxidant supplementation during pregnancy and the risk of developing pre-eclampsia and its related complications. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 3), MEDLINE (1950 to October 2007) and Current Contents (1998 to August 2004). SELECTION CRITERIA: All randomised trials comparing one or more antioxidants with either placebo or no antioxidants during pregnancy for the prevention of pre-eclampsia, and trials comparing one or more antioxidants with another, or with other interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and trial quality and extracted data. MAIN RESULTS: Ten trials, involving 6533 women, were included in this review, five trials were rated high quality. For the majority of trials, the antioxidant assessed was combined vitamin C and E therapy. There was no significant difference between antioxidant and control groups for the relative risk (RR) of pre-eclampsia (RR 0.73, 95% confidence intervals (CI) 0.51 to 1.06; nine trials, 5446 women) or any other primary outcome: severe pre-eclampsia (RR 1.25, 95% CI 0.89 to 1.76; two trials, 2495 women), preterm birth (before 37 weeks) (RR 1.10, 95% CI 0.99 to 1.22; five trials, 5198 women), small-for-gestational-age infants (RR 0.83, 95% CI 0.62 to 1.11; five trials, 5271 babies) or any baby death (RR 1.12, 95% CI 0.81 to 1.53; four trials, 5144 babies). Women allocated antioxidants were more likely to self-report abdominal pain late in pregnancy (RR 1.61, 95% CI 1.11 to 2.34; one trial, 1745 women), require antihypertensive therapy (RR 1.77, 95% CI 1.22 to 2.57; two trials, 4272 women) and require an antenatal hospital admission for hypertension (RR 1.54, 95% CI 1.00 to 2.39; one trial, 1877 women). However, for the latter two outcomes, this was not clearly reflected in an increase in any other hypertensive complications. AUTHORS' CONCLUSIONS: Evidence from this review does not support routine antioxidant supplementation during pregnancy to reduce the risk of pre-eclampsia and other serious complications in pregnancy.

Repeat doses of prenatal corticosteroids for women at risk of preterm birth for preventing neonatal respiratory disease.

BACKGROUND: It is not clear whether there is benefit in repeating the dose of prenatal corticosteroids for women who remain at risk of preterm birth after an initial course. OBJECTIVES: To assess the effectiveness and safety of a repeat dose(s) of prenatal corticosteroids. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 4), MEDLINE (1965 to November 2006), EMBASE (1988 to November 2006) and Current Contents (1997 to November 2006). SELECTION CRITERIA: Randomised controlled trials of women who have already received a single course of corticosteroids seven or more days previously and are still considered to be at risk of preterm birth; outcomes compared for women randomised to receive a repeat dose(s) of prenatal corticosteroids, with women given no further prenatal corticosteroids. DATA COLLECTION AND ANALYSIS: We assessed trial quality and extracted the data independently. MAIN RESULTS: Five trials, involving over 2000 women between 23 and 33 weeks' gestation, are included. Treatment with repeat dose(s) of corticosteroid was associated with a reduction in occurrence (relative risk (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.93, four trials, 2155 infants) and severity of any neonatal lung disease (RR 0.60, 95% CI 0.48 to 0.75, three trials, 2139 infants) and serious infant morbidity (RR 0.79, 95% CI 0.67 to 0.93, four trials, 2157 infants).Mean birthweight was not significantly different between treatment groups (weighted mean difference (WMD) -62.07 g, 95% CI -129.10 to 4.96, four trials, 2273 infants), although in one trial, treatment with repeat dose(s) of corticosteroid was associated with a reduction in birthweight Z score (WMD) -0.13, 95% CI -26 to 0.00, 1 trial, 1144 infants), and in two trials, with an increased risk of being small for gestational age at birth (RR 1.63, 95% CI 1.12 to 2.37, two trials, 602 infants). No statistically significant differences were seen for any of the other primary outcomes that included other measures of respiratory morbidity, fetal and neonatal mortality, periventricular haemorrhage, periventricular leukomalacia and maternal infectious morbidity. Treatment with repeat dose(s) of corticosteroid was associated with a significantly increased risk of caesarean section (RR 1.11, 95% CI 1.01 to 1.22, four trials, 1523 women). AUTHORS' CONCLUSIONS: Repeat dose(s) of prenatal corticosteroids reduce the occurrence and severity of neonatal lung disease and the risk of serious health problems in the first few weeks of life. These short-term benefits for babies support the use of repeat dose(s) of prenatal corticosteroids for women at risk of preterm birth. However, these benefits are associated with a reduction in some measures of weight, and head circumference at birth, and there is still insufficient evidence on the longer-term benefits and risks.

Magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus.

BACKGROUND: Epidemiological and basic science evidence suggests that magnesium sulphate before birth may be neuroprotective for the fetus. OBJECTIVES: To assess the effectiveness and safety of magnesium sulphate as a neuroprotective agent when given to women considered at risk of preterm birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (October 2006), CENTRAL (The Cochrane Library 2006, Issue 3), MEDLINE (1966 to October 2006), EMBASE (1980 to October 2006), Current Contents (1992 to October 2006), references of retrieved articles, and abstracts submitted to the Society for Pediatric Research (1996 to 2006). SELECTION CRITERIA: Randomised controlled trials of antenatal magnesium sulphate therapy given to women threatening or likely to give birth at less than 37 weeks' gestational age. DATA COLLECTION AND ANALYSIS: We independently extracted data regarding clinical outcomes including paediatric mortality, neurologic outcome of survivors (including blindness, deafness, cerebral palsy and major neurosensory disability), and maternal complications and side-effects. At least two authors assessed trial eligibility and quality, and extracted data. MAIN RESULTS: Four trials (3701 babies) were eligible for this review. No statistically significant effect of antenatal magnesium sulphate therapy was detected on any major paediatric outcome, including mortality (e.g., paediatric mortality relative risk (RR) 0.97; 95% confidence interval (CI) 0.74 to 1.28; four trials; 3701 infants), and neurological outcomes in the first few years of life, including cerebral palsy (RR 0.77; 95% CI 0.56 to 1.06; four trials; 3701 infants), neurological impairments or disabilities. There were also no significant effects of antenatal magnesium therapy on combined rates of mortality with neurologic outcomes. There was a significant reduction in the rate of substantial gross motor dysfunction (RR 0.56; 95% CI 0.33 to 0.97; two trials; 2848 infants). There were higher rates of minor maternal side-effects in the magnesium groups, but no significant effects on major maternal complications. AUTHORS' CONCLUSIONS: The role for antenatal magnesium sulphate therapy as a neuroprotective agent for the preterm fetus is not yet established. Given the possible beneficial effects of magnesium sulphate on gross motor function in early childhood, outcomes later in childhood should be evaluated to determine the presence or absence of later potentially important neurologic effects, particularly on motor or cognitive function. Further information will be available from one of the studies where outcomes are being evaluated again at eight to nine years of age, and from another trial currently in progress.