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

• ClinicalTrials.gov Identifier: NCT00790062
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Results First Posted: January 30, 2014
• Last Update Posted: April 8, 2016
• Sponsor: University of Alabama at Birmingham
• 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Uterine Atony; Postpartum Hemorrhage	Drug: Oxytocin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1798 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
• Study Start Date: November 2008
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Oxytocin 10 units/500cc; 1 dose only for prophylaxis given over 1 hour	Drug: Oxytocin; See arms; Other Name: Pitocin
Experimental: Oxytocin 40 units/500cc; One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.	Drug: Oxytocin; See arms; Other Name: Pitocin
Experimental: Oxytocin 80U/500cc; 1 dose only given over 1 hour	Drug: Oxytocin; See arms; Other Name: Pitocin

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment [ Time Frame: baseline to discharge (2 - 3 days) ]
   the number of subjects with any treatment of uterineatony or hemorrhage.
2. Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage [ Time Frame: Initial hospital discharge (2-3 days) ]
   In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.
3. Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors [ Time Frame: baseline to discharge (2-3 days) ]
   The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.

Secondary Outcome Measures :

1. Change in Pre- to Post-delivery Hematocrit (%) [ Time Frame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit ]
   change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
2. Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome [ Time Frame: prior to discharge ]
   the number of individuals with each of the component treatments or individual outcomes in the primary composite.
3. Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc) [ Time Frame: Initial hospital discharge (2-3 days) ]
   the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
4. Number of Subjects With Hospital Stays Greater Than 4 Days [ Time Frame: Initial hospital discharge (2 days or more) ]
   Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
5. Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus [ Time Frame: Initial hospital discharge (2-3 days or more) ]
   number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes 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

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

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

Investigators

• Principal Investigator: Alan T Tita, MD, PhD; University of Alabama at Birmingham

More Information

Additional Information:

PUBMED Abstract of Results 

Publications of Results:

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. doi: 10.1097/AOG.0b013e318242da74.

• Responsible Party: Alan Tita, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00790062
• Other Study ID Numbers: F070910007; 5K12HD001258-09 ( U.S. NIH Grant/Contract )
• First Posted: November 13, 2008
• Results First Posted: January 30, 2014
• Last Update Posted: April 8, 2016
• Last Verified: March 2016

Keywords provided by Alan Tita, University of Alabama at Birmingham:

Uterine atony; Postpartum hemorrhage; clinical trial; Prophylactic oxytocin

Additional relevant MeSH terms:

Postpartum Hemorrhage; Uterine Inertia; Hemorrhage; Pathologic Processes; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Dystocia; Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs