Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Oxytocin

• Registration Number: NCT01914419
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4983

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV infusion	Oxytocin	Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.
IV bolus	Oxytocin	Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.
IM injection	Oxytocin	Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.

Primary Outcome Measures

Name	Time	Method
Proportion of women with postpartum blood loss equal to or greater than 500 mL	1 hour after delivery of baby	Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

Secondary Outcome Measures

Name	Time	Method
Mean postpartum blood loss	1 hour after delivery of the baby	Mean blood loss as measured in a plastic, calibrated container.
Proportion of women with postpartum blood loss equal to or greater than 350 mL	1 hour after delivery of the baby	Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Time to delivery of placenta	Within 1 hour of delivery of the baby	Time interval in minutes between delivery of the baby and delivery of the placenta
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy	Within 1 hour of delivery of the baby
Proportion of women with postpartum blood loss equal to or greater than 1000 mL	1 hour after delivery	Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.
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	Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.

Trial Locations

Locations (2)

Shatby Maternity Hospital, Alexandria University; 🇪🇬 Alexandria, Egypt

El Galaa Teaching Hospital; 🇪🇬 Cairo, Egypt