Introduction of UBT for PPH Management in Three Countries (UBT)

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Other: Uterine balloon tamponade

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abu Hummus, Egypt
    • Abu Hummus Hospital
  • Fayoum, Egypt
    • Fayoum General Hospital
  • Ismailia, Egypt
    • Ismailia General Hospital
  • Itay al Barud, Egypt
    • Etay el Barood Hospital
  • Itsa, Egypt
    • Itsa Hospital
  • Kafr El Dawar, Egypt
    • Kafr el Dawar Hospital
• Senegal
  • Dakar, Senegal
    • Centre de Santé Gaspard Camara
  • Dakar, Senegal
    • Centre de Santé Nabil Choucair
  • Dakar, Senegal
    • Centre de Santé Philip Maguilene Senghor
  • Dakar, Senegal
    • Hôpital Roi Boudoin
  • Mbour, Senegal
    • Centre de Santé Tefess Mbour
  • Mbour, Senegal
    • Hôpital Régional de Mbour
• Uganda
  • Gombe, Uganda
    • Gombe Hospital
  • Itojo, Uganda
    • Itojo Hospital
  • Kiryandongo, Uganda
    • Kiryandongo Hospital
  • Kitagata, Uganda
    • Kitagata Hospital
  • Lyantonde, Uganda
    • Lyantonde Hospital
  • Masindi, Uganda
    • Masindi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Alexandria University; Makerere University; Ministry of Health, Uganda; Ministry of Health and Population, Egypt; Ministere de la Sante et des Services Sociaux; Global Health Uganda LTD; El Galaa Teaching Hospital
• Investigators: Principal Investigator: Ayisha Diop, MPH, Gynuity Health Projects; Principal Investigator: Emad Darwish, MD, Alexandria University; Principal Investigator: Holly Anger, MPH, Gynuity Health Projects; Principal Investigator: Laura Frye, MPH, Gynuity Health Projects; Principal Investigator: Sam Ononge, MD, Makerere University; Principal Investigator: Nevine Hassanien, MD, Consultant; Principal Investigator: Bocar Daff, MD, Ministry of Health, Senegal

Publications and helpful links

General Publications

• Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 15, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Uterine Balloon Tamponade
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 3005