Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-Arm RCT - Full Text View

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00790062

Purpose

This is a double-blind randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduces 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.

Condition	Intervention	Phase
Uterine Atony Postpartum Hemorrhage	Drug: Oxytocin	Phase IV

Drug Information available for: Oxytocin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1800
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxytocin 10 units/500cc: Active Comparator	Drug: Oxytocin See arms
Oxytocin 40 units/500cc: Experimental	Drug: Oxytocin See arms
Oxytocin 80U/500cc: Experimental	Drug: Oxytocin See arms

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790062

Contacts

Contact: Alan TN Tita, MD, PhD

205-934-9616

atita@uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

Responsible Party:	UAB ( Alan T. N. Tita, MD, PhD )
Study ID Numbers:	F070910007
Study First Received:	November 12, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00790062
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Uterine atony
Postpartum hemorrhage
clinical trial
Prophylactic oxytocin

Study placed in the following topic categories:

Dystocia
Postpartum Hemorrhage
Uterine Inertia
Pregnancy Complications
Uterine Hemorrhage

Puerperal Disorders
Obstetric Labor Complications
Hemorrhage
Oxytocin

Additional relevant MeSH terms:

Pathologic Processes
Oxytocics
Therapeutic Uses

Physiological Effects of Drugs
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009