Introduction of UBT for PPH Management in Three Countries

Study Overview
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Brief Summary
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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.

Detailed Description
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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: UBT group: All women diagnosed with PPH following a vaginal delivery and who have an attempted UBT placement (including successful or unsuccessful placements). No-UBT group: All women diagnosed with PPH following a vaginal delivery that do not have an attempted UBT placement.

Official Title
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Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Other: Uterine balloon tamponade


Participation Criteria
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Eligibility Criteria
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Eligibility for stepped wedge trial: Inclusion Criteria: Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere 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 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline period<br>The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites. | |
| Experimental: Uterine balloon tamponade<br>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. | Other: Uterine balloon tamponade<br>* An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal death due to PPH or invasive procedures due to PPH | 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. | After delivery and before discharge from facility (usually within 48 hours after delivery) | 
| Treatment of postpartum infection among women diagnosed with PPH | 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. | Within 4 weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women who receive blood transfusion for PPH management | Proportion of women who receive blood transfusion for PPH management. This outcome will be assessed for the stepped wedge trial. | After delivery and before discharge from facility (usually within 48 hours after delivery) | 
| Transfer to next level care | Proportion of women transferred to the next level referral facility due to PPH. This outcome will be assessed for the stepped wedge trial. | After delivery and before discharge from facility (usually within 48 hours after delivery) | 
| Treatment for severe postpartum infection | Proportion of women diagnosed with PPH who are hospitalized due to postpartum infection and/or receive intravenous antibiotics to treat postpartum infection after hospital discharge and within 4 weeks postpartum. This outcome will be assessed in the nested cohort analysis. | Within 4 weeks after delivery | 
| Level of pain experienced by women postpartum | Level of pain experienced after delivery as reported by women diagnosed with PPH. Pain will be assessed using a 10-point scale. This outcome will be assessed in the nested cohort analysis. | After delivery and before discharge from facility (usually within 48 hours after delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Balloon Tamponade