A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth
NCT ID: NCT04341662
Last Updated: 2025-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
99659 participants
INTERVENTIONAL
2020-10-13
2023-03-24
Brief Summary
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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.
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Detailed Description
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The primary outcome is a composite of the following three clinical outcomes: 1) primary severe PPH defined as blood loss ≥1000 ml following a vaginal birth in the facility measured up to 2 hours postpartum; 2) postpartum laparotomy for bleeding until discharge from the health facility; and 3) postpartum maternal death from bleeding until discharge from the health facility. If any of the components occur, this will be deemed as positive for the primary outcome.
The key secondary implementation outcomes of special interest are 1) PPH detection (with the following numerator and denominator: women who objectively had PPH (source-verified blood loss ≥ 500 mL after weighing of the drape) and were diagnosed with PPH by the birth attendants divided by the total number of women who objectively had PPH (source verified blood loss ≥ 500 mL after weighing the drape), and 2) compliance with MOTIVE bundle (with the following numerator and denominator: women who objectively had PPH and were treated with the PPH bundle following a diagnosis of PPH by the birth attendants divided by the total number of women who objectively had PPH (blood loss ≥ 500 mL after weighing of the drape).
Secondary outcomes: blood transfusion, uterine tamponade, Intensive Care Unit admissions or higher-level facility transfers, and new-born deaths along with implementation and resource use outcomes.
Eighty health facilities will take part in the study. Initially, all health facilities will enter a 7-month baseline period in which they will be following usual care. After this, we will randomise 40 of the 80 health facilities to the E-MOTIVE intervention for 7 months, allowing two months for transition. The other 40 health facilities will continue to follow usual care as per the baseline period for the entire trial duration (16 months). The anticipated sample size for the study will be 215,040 women. This sample size is expected to have over 90% power to detect a 25% relative reduction in the primary outcome from 4% to 3% after allowing for clustering. The number of clusters has been inflated by 10% to allow for drop out of health facilities and for varying cluster sizes. Randomisation will use a minimisation algorithm to balance the intervention and control facilities by the number of vaginal births per health facility, the health facility rate of the composite primary outcome during the baseline phase, the quality of oxytocin used per health facility, and the number of facilities in each arm.
During the 7-month baseline phase, the investigators will refine and optimise the E-MOTIVE implementation strategy by piloting it in two to three facilities per country over up to two adaptive cycles for addressing barriers and enablers to delivery and implementation, ahead of the intervention phase.
The investigators will also conduct a mixed-methods process evaluation to assess the extent to which the E-MOTIVE intervention has been implemented as intended. The implementation outcomes of interest are fidelity, adoption, adaptation, acceptability, and sustainability, as well as contextual influences and barriers and enablers to implementation.
The investigators plan to assess the cost-effectiveness of the E-MOTIVE intervention compared with usual care from a public healthcare system perspective for each country, as measured by incremental cost-effectiveness ratios for a) severe PPH prevented, b) laparotomy for PPH prevented, c) death from PPH avoided, and (d) quality-adjusted life-years prevented.
Following the publication of the E-MOTIVE trial findings, a prospective pre-post intervention study of the E-MOTIVE intervention was planned in eight secondary-level care District Head Quarter (DHQ) hospitals in the Sindh and Punjab provinces of Pakistan. Pakistan was originally scheduled to be part of the multi-country, cluster-randomised E-MOTIVE trial. However, the catastrophic floods in Pakistan in 2022 delayed the start of recruitment, whilst the other participating countries progressed to complete the trial. At this stage, as the required sample size for the trial had been achieved, the Independent Data Monitoring Committee advised completing and analysing the trial without the participation of Pakistan. The definitive effects found by the E-MOTIVE trial made it unethical to conduct further randomised trials of the intervention. As all countries that contributed to the E-MOTIVE trial were from Africa, an outstanding question on generalisability of the findings outside of Africa remained. The E-MOTIVE study in Pakistan was, therefore, planned as a pre-post study to assess the implementation and generalisability of E-MOTIVE in a South Asian healthcare setting. The amended protocol was approved by the University of Birmingham, UK and the Pakistan ethics and regulatory review committee. The study retained the same primary clinical and implementation outcomes as the main trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Usual care
Usual care with dissemination of the current guidelines
Usual care
Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Interventions
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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.
Usual care
Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Eligibility Criteria
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Exclusion Criteria
Patients: All verified vaginal births in the study facilities
FEMALE
Yes
Sponsors
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University College, London
OTHER
University of Melbourne
OTHER
University of California
OTHER
World Health Organization
OTHER
King's College London
OTHER
University of Liverpool
OTHER
Jhpiego
OTHER
Concept Foundation
OTHER
University of Nairobi
OTHER
University of Cape Town
OTHER
Bayero University Kano, Nigeria
OTHER
Muhimbili University of Health and Allied Sciences
OTHER
University of Witwatersrand, South Africa
OTHER
Ammalife
INDUSTRY
Aga Khan University
OTHER
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Arri Coomarasamy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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University of Nairobi
Nairobi, , Kenya
Bayero University
Kano, , Nigeria
Aga Khan University
Karachi, , Pakistan
University of Cape Town
Cape Town, , South Africa
University of the Witwatersrand
Johannesburg, , South Africa
Muhimbili University of Health and Allied Sciences
Dar es Salaam, , Tanzania
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial website
Other Identifiers
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PACTR202002791391791
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG_19-231
Identifier Type: -
Identifier Source: org_study_id
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