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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Uterine Atony; Postpartum Hemorrhage

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00790062

5K12HD001258-09 (U.S. NIH Grant/Contract)

F070910007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,798 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,798 participants in 3 patient groups

Oxytocin 10 units/500cc

Active Comparator group

Description:

1 dose only for prophylaxis given over 1 hour

Treatment:

Drug: Oxytocin

Oxytocin 40 units/500cc

Experimental group

Description:

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

Treatment:

Drug: Oxytocin

Oxytocin 80U/500cc

Experimental group

Description:

1 dose only given over 1 hour

Treatment:

Drug: Oxytocin