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

This study has been completed.

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Alan Tita, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00790062

First received: November 12, 2008

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2008

Last Updated Date

May 4, 2012

Start Date ^ICMJE

November 2008

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Uterine atony or postpartum hemorrhage requiring medical (medication or blood transfusion), surgical or other interventional treatment [ Time Frame: Prior to initial discharge from hospital ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00790062 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The primary outcome in a subgroup of women with risk factors for atony or postpartum hemorrhage [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
Change in pre- to post-delivery hematocrit [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
Each individual treatment or intervention in the primary outcome [ Time Frame: prior to discharge ] [ Designated as safety issue: No ]
Postpartum hemorrhage (clinical estimate greater than 500cc) [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
Hospital stay [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
Hypotension warranting pressor agent or fluid bolus unrelated to epidural [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery

Brief Summary

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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Uterine Atony
Postpartum Hemorrhage

Intervention ^ICMJE

Drug: Oxytocin

See arms

Other Name: Pitocin

Study Arm (s)

Active Comparator: Oxytocin 10 units/500cc
Intervention: Drug: Oxytocin
Experimental: Oxytocin 40 units/500cc
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

Intervention: Drug: Oxytocin
Experimental: Oxytocin 80U/500cc
Intervention: Drug: Oxytocin

Publications *

Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1798

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00790062

Other Study ID Numbers ^ICMJE

F070910007, 5K12HD001258-09

Has Data Monitoring Committee

Yes

Responsible Party

Alan Tita, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators ^ICMJE

Principal Investigator:

Alan T Tita, MD, PhD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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