Introduction of UBT for PPH Management in Three Countries

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Other: Uterine balloon tamponade

Study type: Interventional

Funder types: Other

Identifiers

NCT02910310

3005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60,105 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60,105 participants in 2 patient groups

Baseline period

No Intervention group

Description:

The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites.

Uterine balloon tamponade

Experimental group

Description:

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.

Treatment:

Other: Uterine balloon tamponade