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

NCT04341662 | Completed Results DMC

• 2 other identifiers: RG_19-231PACTR202002791391791
• Study Type: interventional
• Target: 99,659
• Locations: 5 countries
• Sites: 6

Brief 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

Keywords

post-partum haemorrhage; early detection; blood loss measurement; oxytocin; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or; 3) Postpartum Maternal Death From Bleeding. Please See Below for Further Details.

  1. Number of women with primary severe PPH defined as blood loss ≥1000 ml following a vaginal birth in the facility up to 2 hours postpartum 2. Number of women with postpartum laparotomy for bleeding until discharge from the health facility 3. Number of postpartum maternal deaths from bleeding until discharge from the health facility. A Blinded Endpoint Review Committee (BERC) will assess incoming data relevant to the primary outcome in order to confirm if any postpartum laparotomy was performed for bleeding and if any maternal death was due to bleeding

  Postpartum until discharge from the health facility (up to 42 days)

Secondary Outcomes (33)

• PPH Detection

  Up to 24 hours postpartum

• Compliance With MOTIVE Bundle

  Up to 24 hours postpartum

• Number of Women With Laparotomy Postpartum Until Discharge From the Health Facility

  Postpartum until discharge from the health facility (up to 42 days)

• Number of Women With Laparotomy With Compression Sutures Postpartum Until Discharge From the Health Facility

  Postpartum until discharge from the health facility (up to 42 days).

• Number of Women With Laparotomy With Arterial Ligation Postpartum Until Discharge From the Health Facility

  Postpartum until discharge from the healthcare facility (up to 42 days).

Study Arms (2)

E-MOTIVE intervention

EXPERIMENTAL

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: E-MOTIVE intervention

Usual care

ACTIVE COMPARATOR

Usual care with dissemination of the current guidelines

Behavioral: Usual care

Interventions

E-MOTIVE intervention BEHAVIORAL

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.

E-MOTIVE intervention

Usual care BEHAVIORAL

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

Usual care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Research participants: All healthcare providers attending vaginal births at the study facilities.
• Patients: All verified vaginal births in the study facilities

Sponsors & Collaborators

• University of Birmingham: lead
• University College, London: collaborator
• University of Melbourne: collaborator
• University of California: collaborator
• World Health Organization: collaborator
• King's College London: collaborator
• University of Liverpool: collaborator
• Jhpiego: collaborator
• Concept Foundation: collaborator
• University of Nairobi: collaborator
• University of Cape Town: collaborator
• Bayero University Kano, Nigeria: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator
• University of Witwatersrand, South Africa: collaborator
• Ammalife: collaborator
• Aga Khan University: collaborator

Study Sites (6)

University of Nairobi

Nairobi, Kenya

Location

Bayero University

Kano, Nigeria

Location

Aga Khan University

Karachi, Pakistan

Location

University of Cape Town

Cape Town, South Africa

Location

University of the Witwatersrand

Johannesburg, South Africa

Location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (5)

• Gallos I, Devall A, Martin J, Middleton L, Beeson L, Galadanci H, Alwy Al-Beity F, Qureshi Z, Hofmeyr GJ, Moran N, Fawcus S, Sheikh L, Gwako G, Osoti A, Aswat A, Mammoliti KM, Sindhu KN, Podesek M, Horne I, Timms R, Yunas I, Okore J, Singata-Madliki M, Arends E, Wakili AA, Mwampashi A, Nausheen S, Muhammad S, Latthe P, Evans C, Akter S, Forbes G, Lissauer D, Meher S, Weeks A, Shennan A, Ammerdorffer A, Williams E, Roberts T, Widmer M, Oladapo OT, Lorencatto F, Bohren MA, Miller S, Althabe F, Gulmezoglu M, Smith JM, Hemming K, Coomarasamy A. Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage. N Engl J Med. 2023 Jul 6;389(1):11-21. doi: 10.1056/NEJMoa2303966. Epub 2023 May 9.

  PMID: 37158447 RESULT

• Williams EV, Goranitis I, Oppong R, Perry SJ, Devall AJ, Martin JT, Mammoliti KM, Beeson LE, Sindhu KN, Galadanci H, Alwy Al-Beity F, Qureshi Z, Hofmeyr GJ, Moran N, Fawcus S, Mandondo S, Middleton L, Hemming K, Oladapo OT, Gallos ID, Coomarasamy A, Roberts TE. A cost-effectiveness analysis of early detection and bundled treatment of postpartum hemorrhage alongside the E-MOTIVE trial. Nat Med. 2024 Aug;30(8):2343-2348. doi: 10.1038/s41591-024-03069-5. Epub 2024 Jun 6.

  PMID: 38844798 DERIVED

• Forbes G, Akter S, Miller S, Galadanci H, Qureshi Z, Fawcus S, Hofmeyr GJ, Moran N, Singata-Madliki M, Dankishiya F, Gwako G, Osoti A, Thomas E, Gallos I, Mammoliti KM, Devall A, Coomarasamy A, Althabe F, Atkins L, Bohren MA, Lorencatto F. Factors influencing postpartum haemorrhage detection and management and the implementation of a new postpartum haemorrhage care bundle (E-MOTIVE) in Kenya, Nigeria, and South Africa. Implement Sci. 2023 Jan 11;18(1):1. doi: 10.1186/s13012-022-01253-0.

  PMID: 36631821 DERIVED

• Akter S, Forbes G, Miller S, Galadanci H, Qureshi Z, Fawcus S, Justus Hofmeyr G, Moran N, Singata-Madliki M, Amole TG, Gwako G, Osoti A, Thomas E, Gallos I, Mammoliti KM, Coomarasamy A, Althabe F, Lorencatto F, Bohren MA. Detection and management of postpartum haemorrhage: Qualitative evidence on healthcare providers' knowledge and practices in Kenya, Nigeria, and South Africa. Front Glob Womens Health. 2022 Nov 18;3:1020163. doi: 10.3389/fgwh.2022.1020163. eCollection 2022.

  PMID: 36467287 DERIVED

• Bohren MA, Lorencatto F, Coomarasamy A, Althabe F, Devall AJ, Evans C, Oladapo OT, Lissauer D, Akter S, Forbes G, Thomas E, Galadanci H, Qureshi Z, Fawcus S, Hofmeyr GJ, Al-Beity FA, Kasturiratne A, Kumarendran B, Mammoliti KM, Vogel JP, Gallos I, Miller S. Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol. Reprod Health. 2021 Jul 14;18(1):149. doi: 10.1186/s12978-021-01162-3.

  PMID: 34261508 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study limitations include the lack of certain secondary outcomes such as post-natal hemoglobin level and anemia rates, and women's experience of care.

Results Point of Contact

• Title: Dr Adam Devall
• Organization: University of Birmingham

a.j.devall@bham.ac.uk

+447971823452

Study Officials

• Arri Coomarasamy, MD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel cluster randomised trial with a baseline control phase, along with mixed-methods and health economic evaluations

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: April 10, 2020
• Study Start: October 13, 2020
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: April 18, 2025
• Results First Posted: August 6, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after primary publication
• Access Criteria: Data sharing will be subject to agreement by the Trial Management Group

Locations

PA (1); TA (1); NG (1); KE (1); ZA (2)