IV Versus IM Administration of Oxytocin for Postpartum Bleeding

April 27, 2018 updated by: Gynuity Health Projects

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

543

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Corrientes, Argentina
        • Hospital J.R. Vidal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IV Infusion
Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
Drug: IV Oxytocin + IM placebo
Active Comparator: IM administration
Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml
Drug: IM Oxytocin + IV placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of blood loss (mL)
Time Frame: 1 hour postpartum
1 hour postpartum
Proportion of women who had postpartum blood loss ≥500 ml
Time Frame: 1 hour postpartum
1 hour postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Centro Rosarino de Estudios Perinatales (CREP)

Investigators

  • Principal Investigator: Ilana Dzuba, MPH, Gynuity Health Projects
  • Principal Investigator: Guillermo Carroli, MD, Centro Rosarino de Estudios Perinatales (CREP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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