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: March 8, 2016
Last verified: March 2016

November 12, 2008
March 8, 2016
November 2008
June 2010   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    the number of subjects with any treatment of uterineatony or hemorrhage.
  • Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
    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.
  • Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors [ Time Frame: baseline to discharge (2-3 days) ] [ Designated as safety issue: No ]
    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.
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 ]
Complete list of historical versions of study NCT00790062 on ClinicalTrials.gov Archive Site
  • Change in Pre- to Post-delivery Hematocrit (%) [ Time Frame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit ] [ Designated as safety issue: No ]
    change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
  • Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome [ Time Frame: prior to discharge ] [ Designated as safety issue: No ]
    the number of individuals with each of the component treatments or individual outcomes in the primary composite.
  • Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc) [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
    the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
  • Number of Subjects With Hospital Stays Greater Than 4 Days [ Time Frame: Initial hospital discharge (2 days or more) ] [ Designated as safety issue: No ]
    Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
  • Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus [ Time Frame: Initial hospital discharge (2-3 days or more) ] [ Designated as safety issue: Yes ]
    number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)
  • 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 ]
Not Provided
Not Provided
 
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Uterine Atony
  • Postpartum Hemorrhage
Drug: Oxytocin
See arms
Other Name: Pitocin
  • Active Comparator: Oxytocin 10 units/500cc
    1 dose only for prophylaxis given over 1 hour
    Intervention: Drug: Oxytocin
  • Experimental: Oxytocin 40 units/500cc
    One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
    Intervention: Drug: Oxytocin
  • Experimental: Oxytocin 80U/500cc
    1 dose only given over 1 hour
    Intervention: Drug: Oxytocin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1798
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00790062
F070910007, 5K12HD001258-09
Yes
Not Provided
Not Provided
Alan Tita, University of Alabama at Birmingham
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Alan T Tita, MD, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
March 2016

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