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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
Belagavi, Karnataka, India
postpartum hemorrhage
blood loss \>=500 ml after delivery of the baby, as measured through a plastic calibrated drape.
Time frame: after delivery of baby
Oxytocin use before delivery
the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
Time frame: labor and delivery
stillbirth
stillbirth is defined as death of a fetus after 28 weeks of gestation and before birth of the baby
Time frame: pregnancy
neonatal death
neonatal death is defined as death of a live born infant prior to completion of 28 days
Time frame: first month of life
need for neonatal resuscitation
Time frame: 0-6 hours after birth
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