A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth

Summary

Every six minutes a mother dies from postpartum haemorrhage (PPH) in low-resource countries, in the prime of her life and often leaving behind a young family. In many settings, when a mother dies in childbirth, her infant has less than a 20% chance of surviving past the first month. PPH, defined as a blood loss of more than 500 ml, is the leading cause of maternal death worldwide, accounting for 27% of maternal deaths. The WHO published "Recommendations for the Prevention and Treatment of Postpartum Hemorrhage" in 2012 to provide evidence-informed recommendations for managing PPH. However, adherence to these recommendations is currently limited by a number of challenges.

This primary aim of this multi-country, parallel cluster randomised trial with a baseline control phase, along with mixed-methods and health economic evaluations, is to evaluate the implementation of early detection and the use of the World Health Organisation (WHO) MOTIVE 'first response' treatment bundle for postpartum haemorrhage (PPH) on clinical, implementation and resource use outcomes. The investigators will evaluate the implementation through mixed-methods and carry out a health economic evaluation from the public healthcare system perspective.

Conditions

• Post-Partum Haemorrhage

Interventions

BEHAVIORAL

E-MOTIVE intervention

The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.

BEHAVIORAL

Usual care

Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• University of California

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Jhpiego

  collaborator OTHER

• Concept Foundation

  collaborator OTHER

• University of Nairobi

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• Bayero University Kano, Nigeria

  collaborator OTHER

• Muhimbili University of Health and Allied Sciences

  collaborator OTHER

• University of Witwatersrand, South Africa

  collaborator OTHER

• Ammalife

  collaborator INDUSTRY

• Aga Khan University

  collaborator OTHER

• University of Birmingham

  lead OTHER

Principal Investigators

• Arri Coomarasamy, MD · University of Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-13

Primary Completion

2023-03-24

Completion

2023-03-24

Countries

• Kenya
• Nigeria
• Pakistan
• South Africa
• Tanzania

Study Locations