Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via UnijectTM by peripheral health care providers at home births: design of a community-based cluster-randomized trial Full Text
BMC Pregnancy and Childbirth, 06/08/2012
Stanton CK et al. – Complementary data on safety and logistical issues related to this intervention will assist policymakers in low–income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid–2013.Methods
- This study is designed as a community–based cluster–randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the UnijectTM injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor.
- The primary aim is to determine if administration of prophylactic oxytocin via UnijectTM by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention.
- Postpartum hemorrhage is examined under three sequential definitions: blood loss [greater than or equal to]500 ml (BL); treatment for bleeding (TX) and/or BL; hospital referral for bleeding and/or TX and/or BL.
- Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively.
- Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings.