Oxytocin in Uniject™ trial aims to cut postpartum hemorrhage by 44% in Indian home births

Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality globally, particularly in low-resource settings where facility births are less common. Timely administration of uterotonic agents like oxytocin is crucial for preventing PPH by promoting uterine contraction, but access and proper administration can be challenging in home birth settings. The Uniject™ pre-filled syringe system offers a simplified, single-dose delivery method, potentially improving the feasibility and safety of oxytocin administration by community health workers. This trial addresses the critical gap in evidence for its effectiveness and programmatic feasibility when administered by Auxiliary Nurse Midwives (ANMs) in India.

This cluster randomized community-based trial in Bagalkot, India, is designed to evaluate the impact of 10 IU of oxytocin in Uniject™ administered intramuscularly by Auxiliary Nurse Midwives (ANMs) during the third stage of labor. The study targets births occurring in homes, Sub-Centers, and Primary Health Centers. The intervention arm involves ANMs providing the prophylactic oxytocin, while the control arm consists of home births attended by ANMs who do not provide the intervention drug. The primary endpoint is the reduction in the risk of postpartum hemorrhage. Secondary objectives include documenting correct use of oxytocin in Uniject™, adverse maternal and fetal events associated with inappropriate use, and various indicators reflecting programmatic feasibility.

The trial is specifically designed to test the hypothesis that prophylactic intramuscular administration of 10 IU of oxytocin in Uniject™ by ANMs will significantly reduce the incidence of postpartum hemorrhage (PPH). The study's power calculation is based on an expected reduction of PPH by 44%, specifically from a baseline risk of 9% in the control group to 5% in the intervention group. This anticipated reduction is the core outcome the trial aims to validate. Beyond efficacy, the study is also designed to systematically document the correct usage patterns of oxytocin in Uniject™ by ANMs, providing crucial data on adherence to protocol. Furthermore, it will meticulously record any adverse maternal and fetal events that might be associated with inappropriate administration of the drug, ensuring a comprehensive safety profile assessment. The trial will also gather extensive data on programmatic feasibility indicators, which are essential for understanding the practical challenges and successes of implementing such an intervention at scale within the Indian healthcare system. This includes aspects like supply chain, training effectiveness, and community acceptance. The abstract describes the design to measure these outcomes, not the actual results of the completed trial. The most important hypothesized finding is:

The trial hypothesizes that intramuscular 10 IU of oxytocin in Uniject™ will reduce postpartum hemorrhage risk by 44% (from 9% to 5%).