Abstract
BackgroundTwo out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care.MethodsA pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1) structured birth planning and travel facilitation, 2) structured birth planning, and 3) control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat.DiscussionA nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required). The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national technical working group process, and then test a set of arrangements for achieving the enhanced utilization of safe birthing services.Trial registrationCurrent Controlled Trials ISRCTN86264432
Highlights
MethodsA pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013
Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among these countries [1]
Study Design A pragmatic parallel arms cluster randomized controlled trial (c RCT) with three arms will be conducted from February 2011 to May 2013
Summary
Study Design A pragmatic parallel arms cluster randomized controlled trial (c RCT) with three arms will be conducted from February 2011 to May 2013. Well as cross-verifying a sample of these measurements by the respective lady health supervisor ( research staff, where possible) This is possible, we believe this is unlikely that pregnant woman in the control arm would somehow get “structured birth planning” and/or “travel facilitation” from lady health worker in an intervention arm (i.e. LHW associated with another facility and serving some other population) leading to misinterpretation of results. The possible poor quality of EmONC services available at the facilities could lead to an under-estimation of the potential gain from the trial interventions to address the decision and access delays. Efforts will be made, mainly through programme but supplemented with minimal project inputs (if required), to make acceptable quality EmONC services available at the twenty one selected facilities This facility support (if made available) will be same for all the facilities, not introducing any bias in the measurement of association. The potential journals to target includes: BMC Women Health, Lancet, British Medical Journal, WHO Bulletin, International Journal of Gynecology and Obstetrics - overall results of the trial; BMC Implementation Science - process evaluation study (s); Health Policy and Planning, Reproductive Health Matters - social science (qualitative studies)
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