Mario Festin

Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial

BACKGROUND Active management of the third stage of labour reduces the risk of post-partum haemorrhage. We aimed to assess whether controlled cord traction can be omitted from active management of this stage without increasing the risk of severe haemorrhage. METHODS We did a multicentre, non-inferiority, randomised controlled trial in 16 hospitals and two primary health-care centres in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Women expecting to deliver singleton babies vaginally (ie, not planned caesarean section) were randomly assigned (in a 1:1 ratio) with a centrally generated allocation sequence, stratified by country, to placental delivery with gravity and maternal effort (simplified package) or controlled cord traction applied immediately after uterine contraction and cord clamping (full package). After randomisation, allocation could not be concealed from investigators, participants, or assessors. Oxytocin 10 IU was administered immediately after birth with cord clamping after 1-3 min. Uterine massage was done after placental delivery according to local policy. The primary (non-inferiority) outcome was blood loss of 1000 mL or more (severe haemorrhage). The non-inferiority margin for the risk ratio was 1·3. Analysis was by modified intention-to-treat, excluding women who had emergency caesarean sections. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN 12608000434392. FINDINGS Between June 1, 2009, and Oct 30, 2010, 12,227 women were randomly assigned to the simplified package group and 12,163 to the full package group. After exclusion of women who had emergency caesarean sections, 11,861 were in the simplified package group and 11,820 were in the full package group. The primary outcome of blood loss of 1000 mL or more had a risk ratio of 1·09 (95% CI 0·91-1·31) and the upper 95% CI limit crossed the pre-stated non-inferiority margin. One case of uterine inversion occurred in the full package group. Other adverse events were haemorrhage-related. INTERPRETATION Although the hypothesis of non-inferiority was not met, omission of controlled cord traction has very little effect on the risk of severe haemorrhage. Scaling up of haemorrhage prevention programmes for non-hospital settings can safely focus on use of oxytocin. FUNDING United States Agency for International Development and UN Development Programme/UN Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research.

International survey on variations in practice of the management of the third stage of labour.

OBJECTIVE To determine the use of the active management of the third stage of labour in 15 university-based obstetric centres in ten developing and developed countries and to determine whether evidence-based practices were being used. METHODS From March 1999 to December 1999, the Global Network for Perinatal and Reproductive Health (GNPRH) conducted an observational, cross-sectional survey to assess the use of the practice and its components. Prospective data on patient characteristics and the interventions used in the management of the third stage of labour were collected using standardized methods. Data on approximately 30 consecutive vaginal deliveries in each centre (452 in total) were included. FINDINGS Significant intracountry and intercountry variation in the practice of the active management of the third stage of labour was found (111/452 deliveries used active management), which confirmed the existence of a large gap between knowledge and practice. CONCLUSION Areas identified for improvement are the urgent implementation of the evidence-based clinical management practice defined as the active management of the third stage of labour; increased accessibility to systematic reviews in developing countries; and the conduction of clinical trials that assess the impact of this intervention in other settings.

Validation study of women's reporting and recall of major obstetric complications treated at the Philippine General Hospital

In settings where most births occur at home, collection of data on complications experienced around the time of delivery is often dependent on self‐reported data, collected through individual interviews. This paper describes a study designed to validate interview data on obstetric complications by comparing womens responses with data extracted from their medical records. The major complications of hemorrhage, dystocia, sepsis, and eclampsia were the main focus of the study. The sample was drawn from women hospitalized for delivery in a Manila hospital within the past 4 years. The main goal of the study was to assist in development of a survey instrument to be used in a national sample survey of women in the Philippines. The best sensitivity and specificity, respectively, for combinations of questions on these four conditions were: for hemorrhage, 0.70 and 0.78; for dystocia, 0.69 and 0.97; for sepsis, 0.89 and 0.83; and for eclampsia, 0.44 and 0.96. There were no significant differences in the duration of the recall periods according to diagnosis.

Caesarean section in four South East Asian countries: reasons for, rates, associated care practices and health outcomes

BackgroundCaesarean 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.MethodsData 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.ResultsOverall 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.ConclusionRates and reasons for caesarean section and associated clinical care practices and health outcomes varied widely between the four South East Asian countries.

An international survey of practice variation in the use of antibiotic prophylaxis in cesarean section.

Objective: To examine the use of antibiotic prophylaxis in cesarean section in different countries and in relation to a reference regimen. Method: Fifty consecutive cesarean sections performed in eight centers in five countries were surveyed. Data from each center were compared to a regimen recommended by the Cochrane Collaboration (one dose of ampicillin or cefazolin administered to all women shortly before the procedure or immediately after cord clamping) using logistic regression with adjustment for procedure type. Result: Prophylaxis was used widely, but only four centers administered prophylaxis to all women. Ampicillin and cefazolin were the principal antibiotics used, but broad‐spectrum agents and multidrug regimens were also used commonly. Only two centers reliably administered the antibiotic at the appropriate time. The majority of women received only one dose of antibiotic in only three centers. Conclusion: The use of antibiotic prophylaxis in cesarean section was variable and often at odds with published recommendations.

One-day compared with 7-day nitrofurantoin for asymptomatic bacteriuria in pregnancy: a randomized controlled trial.

OBJECTIVE: To evaluate whether a 1-day nitrofurantoin regimen is as effective as a 7-day regimen in eradicating asymptomatic bacteriuria during pregnancy. METHODS: A multicenter, double-blind, randomized, placebo controlled noninferiority trial was conducted in antenatal clinics in Thailand, the Philippines, Vietnam, and Argentina. Pregnant women seeking antenatal care between March 2004 and March 2007 who met the inclusion and exclusion criteria were invited to participate in the study. Those who consented were randomly allocated to receive either a 1-day or a 7-day course of 100 mg capsules of nitrofurantoin, which was taken twice daily. The primary outcome was bacteriologic cure on day 14 of treatment. RESULTS: A total of 1,248 of 24,430 eligible women had asymptomatic bacteriuria, making the overall prevalence of 5.1%. Of these 1,248 women, 778 women were successfully recruited, and 386 and 392 women were randomly allocated to 1-day and 7-day regimens, respectively. Escherichia coli was the most common potentially pathogenic bacteria detected, its prevalence approaching 50%. Bacteriologic cure rates at treatment day 14 were 75.7% and 86.2% for 1-day and 7-day regimens, respectively. The cure rate difference was –10.5% (95% confidence interval −16.1% to −4.9%). Mean birth weight and mean gestational age at delivery were significantly lower in the 1-day regimen group. There were fewer adverse effects in the 1-day regimen group, but the differences were not statistically significant. CONCLUSION: A 1-day regimen of nitrofurantoin is significantly less effective than a 7-day regimen. Women with asymptomatic bacteriuria in pregnancy should receive the standard 7-day regimen. CLINICAL TRIAL REGISTRATION: ISRCTN, isrctn.org, ISRCTN11966080 LEVEL OF EVIDENCE: I

Optimising reproductive and child health outcomes by building evidence-based research and practice in South East Asia (SEA-ORCHID): study protocol

BackgroundDisorders related to pregnancy and childbirth are a major health issue in South East Asia. They represent one of the biggest health risk differentials between the developed and developing world. Our broad research question is: Can the health of mothers and babies in Thailand, Indonesia, the Philippines and Malaysia be improved by increasing the local capacity for the synthesis of research, implementation of effective interventions, and identification of gaps in knowledge needing further research?Methods/DesignThe project is a before-after study which planned to benefit from and extend existing regional and international networks. Over five years the project was designed to comprise five phases; pre-study, pre-intervention, intervention, outcome assessment and reporting/dissemination. The study was proposed to be conducted across seven project nodes: four in South East Asia and three in Australia. Each South East Asian study node was planned to be established within an existing department of obstetrics and gynaecology or neonatology and was intended to form the project coordinating centre and focus for evidence-based practice activities within that region. Nine hospitals in South East Asia planned to participate, representing a range of clinical settings. The three project nodes in Australia were intended to provide project support.The intervention was planned to consist of capacity-strengthening activities targeted at three groups: generators of evidence, users of evidence and teachers of evidence. The primary outcome was established as changes in adherence to recommended clinical practices from baseline to completion of the project and impact on health outcomes.DiscussionThe SEA-ORCHID project was intended to improve care during pregnancy and the perinatal period of mothers and their babies in South East Asia. The possible benefits extend beyond this however, as at the end of this project there is hoped to be an existing network of South East Asian researchers and health care providers with the capacity to generalise this model to other health priority areas. It is anticipated that this project facilitate ongoing development of evidence-based practice and policy in South East Asia through attracting long-term funding, expansion into other hospitals and community-based care and the establishment of nodes in other countries.

Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial

BackgroundThe third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60–70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care.ObjectiveThe primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package.MethodsA hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour.The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000 ml or more at one hour and up to two hours for women who continue to bleed after one hour. The secondary outcomes are blood transfusion, the use of additional uterotonics and measure of severe morbidity and maternal death.We aim to recruit 25,000 women delivering vaginally in health facilities in eight countries within a 12 month recruitment period.ManagementOverall trial management will be from HRP/RHR in Geneva. There will be eight centres located in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda. There will be an online data entry system managed from HRP/RHR. The trial protocol was developed following a technical consultation with international organizations and leading researchers in the field.Expected outcomesThe main objective of this trial is to investigate whether a simplified package of third stage management can be recommended without increasing the risk of PPH. By avoiding the need for a manual procedure that requires training, the third stage management can be implemented in a more widespread and cost-effective way around the world even at the most peripheral levels of the health care system. This trial forms part of the programme of work to reduce maternal deaths due to postpartum haemorrhage within the RHR department in collaboration with other research groups and organizations active in the field.Trial RegistrationACTRN12608000434392

Infections in International Pregnancy Study: Performance of the Optical Immunoassay Test for Detection of Group B Streptococcus

ABSTRACT We evaluated the Strep B optical immunoassay (OIA; ThermoBiostar, Inc.) for detecting light and heavy group B streptococcus colonization in 1,306 pregnant women. The women were examined at 20 to 32 weeks gestation and were from six countries. Compared to culture, the sensitivity and specificity of OIA were 13.3 and 98.4%, respectively, for light colonization and 41.5 and 97.7%, respectively, for heavy colonization.

A global research agenda for family planning: results of an exercise for setting research priorities

OBJECTIVE To develop a global research agenda that will guide investment in effective interventions to satisfy the large unmet need for modern methods of family planning. METHODS In a global survey, experts on contraception were invited to identify and rank the types of research that would be needed--and the knowledge gaps that would have to be filled--to reduce the unmet need for family planning in the next decade. The experts were then asked to score the research on a given topic in terms of the likelihood of its leading to an intervention that would: (i) be deliverable, affordable and sustainable; (ii) substantially reduce the unmet need for contraceptives; (iii) be effective and efficient in improving health systems; (iv) be ethically implemented; and (v) improve equity in the target population. The overall scores were then ranked. FINDINGS Most of the topics that received the 15 highest scores fell into three categories: implementation of policies in family planning; the integration of services to address barriers to contraceptive use; and interventions targeted at underserved groups, such as adolescents. CONCLUSION Experts on contraception gave top priority ranking to research on improving the implementation and integration of health services and on strengthening the health systems supporting family planning services. The results of the exercise may help decision-makers, researchers and funding agencies to develop a clear and focused approach to satisfying the global need for family planning and reach the target set by the Family Planning 2020 initiative.