Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study

Gynuity Health Projects1 site in 1 country543 target enrollmentDecember 1, 2016

ConditionsPostpartum Hemorrhage

InterventionsIV Oxytocin + IM placebo IM Oxytocin + IV placebo

DrugsIV Oxytocin + IM placebo IM Oxytocin + IV placebo

Overview

Phase: Phase 4
Intervention: IV Oxytocin + IM placebo
Conditions: Postpartum Hemorrhage
Sponsor: Gynuity Health Projects
Enrollment: 543
Locations: 1
Primary Endpoint: Amount of blood loss (mL)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 1, 2016

End Date

October 1, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Gynuity Health Projects

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

IV Infusion

Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU

Intervention: IV Oxytocin + IM placebo

IM administration

Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml

Intervention: IM Oxytocin + IV placebo

Outcomes

Primary Outcomes

Amount of blood loss (mL)

Time Frame: 1 hour postpartum

Proportion of women who had postpartum blood loss ≥500 ml

Time Frame: 1 hour postpartum

Secondary Outcomes

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)
Side effects(1 hour 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)