Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
Overview
- Phase
- Not Applicable
- Intervention
- Oxytocin
- Conditions
- Postpartum Hemorrhage
- Sponsor
- Gynuity Health Projects
- Enrollment
- 4983
- Locations
- 2
- Primary Endpoint
- Proportion of women with postpartum blood loss equal to or greater than 500 mL
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.
Detailed Description
The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All women who present in active labor for a live birth at the study hospital will be considered for participation in the study
Exclusion Criteria
- •Planned or transferred for delivery via Cesarean section
- •Administration of a pre-delivery uterotonic to induce or augment labor
- •Unable to provide informed consent due to mental impairment, distress during labor or other reason
Arms & Interventions
IV infusion
Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.
Intervention: Oxytocin
IV bolus
Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.
Intervention: Oxytocin
IM injection
Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.
Intervention: Oxytocin
Outcomes
Primary Outcomes
Proportion of women with postpartum blood loss equal to or greater than 500 mL
Time Frame: 1 hour after delivery of baby
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Secondary Outcomes
- Proportion of women with postpartum blood loss equal to or greater than 350 mL(1 hour after delivery of the baby)
- Time to delivery of placenta(Within 1 hour of delivery of the baby)
- Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy(Within 1 hour of delivery of the baby)
- Mean postpartum blood loss(1 hour after delivery of the baby)
- Proportion of women with postpartum blood loss equal to or greater than 1000 mL(1 hour after delivery)
- Side effects 1 hour postpartum(1 hour after delivery of the baby)
- Mean change in hemoglobin pre-delivery to postpartum(At least 12 hours after removal of IV and within 48 hours of delivery of the baby)