Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60,105
- 试验地点
- 18
- 主要终点
- Maternal death due to PPH or invasive procedures due to PPH
研究概览
简要总结
This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.
详细描述
To assess the effectiveness of introduction of the UBT, a stepped wedge cluster randomized design will be employed to monitor maternal health outcomes among vaginal deliveries occurring at all participating facilities during the study phases described below:
Baseline phase: A baseline phase will be conducted in all participating sites before training and introduction of the UBT for PPH management. This phase will consist of prospective data collection to establish the baseline rates of key study outcomes.
Step 1 intervention phase: In this phase, participating sites will be randomized such that half will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice and half will continue data collection without UBT introduction.
Step 2 intervention phase: In this phase, the remaining sites will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice. During this phase, all participating sites will continue data collection to document study outcomes and all will be using UBT in their standard practice.
To assess the safety and acceptability of the use of UBT for PPH management, a nested cohort analysis will be done among women diagnosed with PPH during the stepped wedge trial. The investigators will assess the rates of treatment of postpartum infection and examine acceptability of care provided among the following two cohorts of women:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligibility for stepped wedge trial:
- •Inclusion Criteria:
- •Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
排除标准
- •Delivery via Cesarean section
- •Transferred to another facility before delivery
- •Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
- •Eligibility for nested cohort analysis:
- •Inclusion criteria
- •Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
- •Diagnosed and treated for PPH during the stepped wedge trial
- •Willing and able to give informed consent
- •Agree to participate in a postpartum interview before hospital discharge
- •Agree to brief follow-up interview 4 weeks after delivery
- •Exclusion criteria
- •Delivery via Cesarean section
- •Transferred to another facility before delivery
- •Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
研究组 & 干预措施
Baseline period
The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites.
Uterine balloon tamponade
The UBT period will involve data collection on study outcomes after providers at sites are trained on UBT use and UBT is introduced into PPH management practice at study sites.
干预措施: Uterine balloon tamponade (Other)
结局指标
主要结局
Maternal death due to PPH or invasive procedures due to PPH
时间窗: After delivery and before discharge from facility (usually within 48 hours after delivery)
Proportion of women who experience maternal death due to PPH or who receive invasive procedures (including compression/B Lynch sutures, uterine artery ligation, uterine artery embolization, and hysterectomy) for PPH management. This is the primary outcome for the stepped wedge trial.
Treatment of postpartum infection among women diagnosed with PPH
时间窗: Within 4 weeks after delivery
Proportion of women diagnosed with PPH who receive antibiotics for presumptive or confirmed postpartum infection after hospital discharge and within 4 weeks postpartum. This is the primary outcome for the nested cohort analysis.
次要结局
- Transfer to next level care(After delivery and before discharge from facility (usually within 48 hours after delivery))
- Proportion of women who receive blood transfusion for PPH management(After delivery and before discharge from facility (usually within 48 hours after delivery))
- Treatment for severe postpartum infection(Within 4 weeks after delivery)
- Level of pain experienced by women postpartum(After delivery and before discharge from facility (usually within 48 hours after delivery))