Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-06-30

Brief Summary

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This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.

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Detailed Description

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Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.

Conditions

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Uterine Atony Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxytocin 10 units/500cc

1 dose only for prophylaxis given over 1 hour

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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Oxytocin 40 units/500cc

One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

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Oxytocin 80U/500cc

1 dose only given over 1 hour

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

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Interventions

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Oxytocin

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Intervention Type DRUG

Other Intervention Names

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Pitocin

Eligibility Criteria

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Inclusion Criteria

* \> 24 weeks, viable pregnancy, singleton or twins

Exclusion Criteria

* No consent
* Contraindication to oxytocin
* Antepartum fetal demise
* Intrapartum use of concentrated oxytocin
* Planned cesarean
* DIC or coagulopathy

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No