IV Versus IM Administration of Oxytocin for Postpartum Bleeding

Phase 4

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: IV Oxytocin + IM placebo; Drug: IM Oxytocin + IV placebo

• Registration Number: NCT02954068
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2016-12-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-10-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 543

Inclusion Criteria

• She is present to give birth to a live fetus
• Vaginal delivery
• Willing to participate in the study
• Able to give informed consent

Exclusion Criteria

• Scheduled for a cesarean
• Reject the placement of an IV during labor (for intravenous infusion)
• Cannot give informed consent for any reason
• Not willing and / or cannot answer questions about background

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Infusion	IV Oxytocin + IM placebo	Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
IM administration	IM Oxytocin + IV placebo	Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml

Primary Outcome Measures

Name	Time	Method
Amount of blood loss (mL)	1 hour postpartum
Proportion of women who had postpartum blood loss ≥500 ml	1 hour postpartum

Secondary Outcome Measures

Name	Time	Method
Side effects	1 hour postpartum
Average time required until expulsion of the placenta	1 hour postpartum
Heart rate	15, 30, 45 and 60 minutes postpartum
Proportion of women who had postpartum blood loss ≥1000 ml	1 hour postpartum
Average change in hemoglobin level	pre-delivery and at least 24 hours postpartum
Proportion who needed additional Interventions	Through study completion, an average of 24-48 hours postpartum
Blood pressure	15, 30, 45 and 60 minutes postpartum

Trial Locations

Locations (1)

Hospital J.R. Vidal; 🇦🇷 Corrientes, Argentina