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

Background Disorders 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/Design The 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. Discussion The 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.David J Henderson-Smart, Pisake Lumbiganon, Mario R Festin, Jacqueline J Ho, Hakimi Mohammad, Steve J McDonald, Sally Green and Caroline A Crowther for the SEA-ORCHID Study Grou

Building capacity for evidence generation, synthesis and implementation to improve the care of mothers and babies in South East Asia: methods and design of the SEA-ORCHID Project using a logical framework approach

Background: Rates of maternal and perinatal mortality remain high in developing countries despite the existence of effective interventions. Efforts to strengthen evidence-based approaches to improve health in these settings are partly hindered by restricted access to the best available evidence, limited training in evidence-based practice and concerns about the relevance of existing evidence. South East Asia - Optimising Reproductive and Child Health in Developing Countries (SEA-ORCHID) was a five-year project that aimed to determine whether a multifaceted intervention designed to strengthen the capacity for research synthesis, evidence-based care and knowledge implementation improved clinical practice and led to better health outcomes for mothers and babies. This paper describes the development and design of the SEA-ORCHID intervention plan using a logical framework approach. Methods: SEA-ORCHID used a before-and-after design to evaluate the impact of a multifaceted tailored intervention at nine sites across Thailand, Malaysia, Philippines and Indonesia, supported by three centres in Australia. We used a logical framework approach to systematically prepare and summarise the project plan in a clear and logical way. The development and design of the SEA-ORCHID project was based around the three components of a logical framework (problem analysis, project plan and evaluation strategy). Results: The SEA-ORCHID logical framework defined the project's goal and purpose (To improve the health of mothers and babies in South East Asia and To improve clinical practice in reproductive health in South East Asia), and outlined a series of project objectives and activities designed to achieve these. The logical framework also established outcome and process measures appropriate to each level of the project plan, and guided project work in each of the participating countries and hospitals. Conclusions: Development of a logical framework in the SEA-ORCHID project enabled a reasoned, logical approach to the project design that ensured the project activities would achieve the desired outcomes and that the evaluation plan would assess both the process and outcome of the project. The logical framework was also valuable over the course of the project to facilitate communication, assess progress and build a shared understanding of the project activities, purpose and goal.Steve McDonald, Tari Turner, Catherine Chamberlain, Pisake Lumbiganon, Jadsada Thinkhamrop, Mario R Festin, Jacqueline J Ho, Hakimi Mohammad, David J Henderson-Smart, Jacki Short, Caroline A Crowther, Ruth Martis, Sally Green for the SEA-ORCHID Study Grou

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.Mario R Festin, Malinee Laopaiboon, Porjai Pattanittum, Melissa R Ewens, David J Henderson-Smart and Caroline A Crowther for The SEA-ORCHID Study Grou

Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men

CONTEXT: The development of a safe and effective reversible method of male contraception is still an unmet need. OBJECTIVE: Evaluation of suppression of spermatogenesis and contraceptive protection by coadministered im injections of progestogen and testosterone. DESIGN: Prospective multicentre study. SETTING: Ten study centers. PARTICIPANTS: Healthy men, aged 18-45 years, and their 18- to 38-year-old female partners, both without known fertility problems. INTERVENTION: Intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, administered every 8 weeks. MAIN OUTCOMES MEASURES: Suppression of spermatogenesis by ejaculate analysis, contraceptive protection by pregnancy rate. RESULTS: Of the 320 participants, 95.9 of 100 continuing users (95% confidence interval [CI], 92.8-97.9) suppressed to a sperm concentration less than or equal to 1 million/mL within 24 weeks (Kaplan-Meier method). During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59-4.14). The cumulative reversibility of suppression of spermatogenesis after 52 weeks of recovery was 94.8 per 100 continuing users (95% CI, 91.5-97.1). The most common adverse events were acne, injection site pain, increased libido, and mood disorders. Following the recommendation of an external safety review committee the recruitment and hormone injections were terminated early. CONCLUSIONS: The study regimen led to near-complete and reversible suppression of spermatogenesis. The contraceptive efficacy was relatively good compared with other reversible methods available for men. The frequencies of mild to moderate mood disorders were relatively high

Effect of BMI and body weight on pregnancy rates with LNG as emergency contraception: analysis of four WHO HRP studies

Objective: To estimate the effect of increased body weight and body mass index (BMI) on pregnancy rates with levonorgestrel (LNG) 1.5mg used as emergency contraception (EC). Methods: The study reviewed data from 6873 women in four WHO-HRP randomized trials on EC conducted between 1993 and 2010. Participants took either 1.5mg of LNG as a single dose or in two doses 12h apart, up to 120h of unprotected intercourse. Contraceptive efficacy (pregnancy rates) at different weight and BMI categories was evaluated. Results: Overall pregnancy rate was low at 1.2%. Pregnancy rates were also low in women weighing over 80kg (0.7%) and who were obese (BMI over 30kg/m2) (2.0%). The pooled analyses for pregnancy demonstrated that BMI over 30kg/m2 decreased efficacy significantly (odds ratio 8.27, 95% confidence interval = 2.70-25.37) when compared to women in lower BMI categories, mainly influenced by pregnancies in obese women from one study site. Sensitivity analyses excluding that site showed that obesity was no longer a risk factor; however, the other studies included too few obese women in the sample to exclude a substantial decrease in efficacy. Conclusions: Pregnancy rates with use of LNG 1.5mg for EC were low at less than 3% across different weight and BMI categories. Pooled analyses showed an increase in pregnancy rates among obese women (BMI more than 30kg/m2) compared to women with normal BMI levels, influenced by pregnancies all coming from one study site. Implications: Access to LNG as EC should still be promoted to women who need them, and not be restricted in any weight or BMI category, with additional attention for counselling and advice for obese women

Assessment of country policies affecting reproductive health for adolescents in the Philippines

Abstract Background Adolescents in the Philippines face many legal, social and political barriers to access sexual and reproductive health (SRH) services, putting them at higher risk of unplanned pregnancy, abortion, sexually transmitted infections and HIV, and other health and development problems. Objective This study aims to evaluate whether current normative documents on SRH in the Philippines are in concurrence with adolescents’ human rights principles using the World Health Organization (WHO) Guidance and Recommendations on ensuring human rights in the provision of contraceptive information and services. Methods The review focused on policies and normative guidance documents which included the national reproductive health law, its implementing rules and regulations, and the Supreme Court decisions on the law, and documents cited in the government’s Adolescent and Youth Health Programme. Also included were documents identified through keyword searches in an online database of the health department. We assessed these documents on their agreement or non-agreement with WHO recommendations, and the presence or absence of adolescent-specific content. Results Of nine WHO summary recommendations, Philippine normative documents are in agreement with four, namely on acceptability, participation, accountability, and quality, and have adolescent-specific provisions in three. Philippine normative documents are partly in agreement with the remaining five WHO summary recommendations—nondiscrimination, availability, accessibility, informed decision-making, and privacy. Of twenty-four WHO sub-recommendations, Philippine normative documents are in agreement with fifteen, not in agreement with five, and partly in agreement with four. Two possible factors may explain the many documents with conflicting contents: devolution of the Philippine health system, and the deep social and policy divide on sexual and reproductive health. Conclusion Many Philippine-governmental norms and standards are in agreement with adolescents’ human rights to contraceptive information and services as recommended by the WHO. However, a significant number are restrictive, reflecting the strong influence of conservative religious beliefs. Recommendations We recommend: 1) further elaboration of the laws and policies that are fully in agreement with WHO recommendations; 2) a more liberal interpretation of the law to ensure the provision, delivery and access to reproductive health care services, and to promote, protect and fulfill women’s reproductive health and rights; and 3) popularization of ethical and human rights norms