Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India

Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India

This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.

Inclusion Criteria:

• gestational age >=28 wks at enrollment
• anticipate spontaneous vaginal delivery
• hemoglobin >=8 gm/dl
• delivery at home, sub-center, or primary health center
• delivery attended by Auxilliary Nurse Midwife

Exclusion Criteria:

• previous caesarean-section
• scheduled for caesarean-section
• antepartum bleeding during current pregnancy
• blood pressure >140mm of Hg systolic and >90mm of Hg diastolic
• in active labor at time of recruitment
• high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery