Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,798
- 试验地点
- 1
- 主要终点
- Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •> 24 weeks, viable pregnancy, singleton or twins
排除标准
- •No consent
- •Contraindication to oxytocin
- •Antepartum fetal demise
- •Intrapartum use of concentrated oxytocin
- •Planned cesarean
- •DIC or coagulopathy
研究组 & 干预措施
Oxytocin 10 units/500cc
1 dose only for prophylaxis given over 1 hour
干预措施: Oxytocin (Drug)
Oxytocin 40 units/500cc
One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
干预措施: Oxytocin (Drug)
Oxytocin 80U/500cc
1 dose only given over 1 hour
干预措施: Oxytocin (Drug)
结局指标
主要结局
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
时间窗: 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.
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
时间窗: baseline to discharge (2 - 3 days)
the number of subjects with any treatment of uterineatony or hemorrhage.
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
时间窗: 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.
次要结局
- Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome(prior to discharge)
- Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus(Initial hospital discharge (2-3 days or more))
- Change in Pre- to Post-delivery Hematocrit (%)(During delivery hospitalization: Admission hematocrit - post-delivery hematocrit)
- Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)(Initial hospital discharge (2-3 days))
- Number of Subjects With Hospital Stays Greater Than 4 Days(Initial hospital discharge (2 days or more))
研究者
Alan Tita
Associate Professor
University of Alabama at Birmingham