Open Access Study protocol

Making birthing safe for Pakistan women: a cluster randomized trial

Muhammad Amir Khan1, Shirin Mirza1*, Maqsood Ahmed1, Akhtar Rasheed2, Amanullah Khan3, John Walley4 and Nailah Nisar5

Author Affiliations

1 Association for Social Development, Islamabad, Pakistan

2 Provincial Programme for Family planning and Primary health care (Lady Health workers programme) for Punjab, Lahore, Pakistan

3 Save the Children, Islamabad, Pakistan

4 Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK

5 The Royal Surrey County Hospital NHS Foundation Trust, Surrey, UK

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BMC Pregnancy and Childbirth 2012, 12:67  doi:10.1186/1471-2393-12-67

Published: 15 July 2012



Two 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.


A 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.


A 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 registration

Current Controlled Trials ISRCTN86264432