Introduction of UBT for PPH Management in Three Countries

Summary

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.

Conditions

• Postpartum Hemorrhage

Interventions

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

Sponsors & Collaborators

• Ministry of Health and Population, Egypt

  collaborator OTHER_GOV

• Alexandria University

  collaborator OTHER

• El Galaa Teaching Hospital

  collaborator OTHER

• Global Health Uganda LTD

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Ministry of Health, Uganda

  collaborator OTHER_GOV

• Ministere de la Sante et des Services Sociaux

  collaborator OTHER

• Gynuity Health Projects

  lead OTHER

Principal Investigators

• Holly Anger, MPH · Gynuity Health Projects

• Rasha Dabash, MPH · Gynuity Health Projects

• Laura Frye, MPH · Gynuity Health Projects

• Ayisha Diop, MPH · Gynuity Health Projects

• Sam Ononge, MD · Makerere University

• Nevine Hassanien, MD · Consultant

• Mohamed Cherine Ramadan, MD · El Galaa Teaching Hospital

• Emad Darwish, MD · Alexandria University

• Bocar Daff, MD · Ministry of Health, Senegal

• Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2018-02-28

Completion

2018-03-31

Countries

• Egypt
• Senegal
• Uganda

Study Locations