Clinical trial NCT00790062: Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Official title: Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Atony
Postpartum Hemorrhage
Keywords: Uterine atony
Postpartum hemorrhage
clinical trial
Prophylactic oxytocin
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-11-13
Enrollment: 1798
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
timeFrame: baseline to discharge (2 - 3 days)
measure: Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
timeFrame: Initial hospital discharge (2-3 days)
measure: Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
timeFrame: baseline to discharge (2-3 days)
Secondary outcomes:
measure: Change in Pre- to Post-delivery Hematocrit (%)
timeFrame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit
measure: Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
timeFrame: prior to discharge
measure: Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
timeFrame: Initial hospital discharge (2-3 days)
measure: Number of Subjects With Hospital Stays Greater Than 4 Days
timeFrame: Initial hospital discharge (2 days or more)
measure: Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
timeFrame: Initial hospital discharge (2-3 days or more)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Alan T Tita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.