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Completed

NCT Number: NCT00790062

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

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.

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Key information

Conditions

Uterine Atony Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Uterine Inertia

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

See arms

Other names: Pitocin

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2008
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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