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IV Versus IM Administration of Oxytocin for Postpartum Bleeding

NCT ID: NCT02954068

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-10-01

Brief Summary

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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

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Conditions

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Postpartum Hemorrhage

Keywords

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Oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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IV Infusion

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

Group Type ACTIVE_COMPARATOR

IV Oxytocin + IM placebo

Intervention Type DRUG

IM administration

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

Group Type ACTIVE_COMPARATOR

IM Oxytocin + IV placebo

Intervention Type DRUG

Interventions

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IV Oxytocin + IM placebo

Intervention Type DRUG

IM Oxytocin + IV placebo

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Rosarino de Estudios Perinatales (CREP)

UNKNOWN

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Ilana Dzuba, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Guillermo Carroli, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Rosarino de Estudios Perinatales (CREP)

Locations

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Hospital J.R. Vidal

Corrientes, , Argentina

Site Status

Countries

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Argentina

References

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Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.

Reference Type DERIVED
PMID: 33169839 (View on PubMed)

Other Identifiers

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3008

Identifier Type: -

Identifier Source: org_study_id