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E-MOTIVE trial (early detection and bundled treatment of postpartum haemorrhage)

A large trial in 80 hospitals in four African countries that tested a package for heavy bleeding after vaginal birth: a blood-collection drape to measure bleeding early, a bundle of first treatments given together when bleeding passes a set point, and training to make staff use them. Fewer women in the package hospitals had the combined outcome of severe bleeding, surgery for bleeding or death from bleeding (1.6% against 4.3%) than in hospitals giving usual care. The trial tested the whole package, not one part.

Also called E-MOTIVE · Early Detection of Postpartum Haemorrhage and Treatment Using the World Health Organisation MOTIVE First Response Bundle

  • Study
  • In this atlas

Overview

Design
International cluster-randomised trial; the hospital was the unit of randomisation. Registry values: allocation randomised, parallel model, no masking listed.
Phase
Not applicable
Enrolled
  • 99,659 participants (registry enrollment, type ACTUAL; the registry describes participants as health care providers attending vaginal births) (enrolled count) (A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth, retrieved )
  • 80 hospitals (secondary-level hospitals randomised as clusters) (randomized count) (Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage, retrieved )
  • 210,132 patients who underwent vaginal delivery in the randomised hospitals (the hospitals, not the patients, were randomised) (unknown count) (Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage, retrieved )
Sponsor
Not recorded
Funder
Registry
  • NCT NCT04341662
Started
(actual) (A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth, retrieved )
Primary completion
(actual) (A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth, retrieved )
Completion
(actual) (A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth, retrieved )
Results first posted
(actual) (A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth, retrieved )
Countries
Kenya, Nigeria, South Africa, Tanzania, Pakistan (Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage, retrieved ) (A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (ClinicalTrials.gov, retrieved )

Technical summary

International cluster-randomised trial (2023; PMID 37158447; NCT04341662). 80 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania, 210,132 patients who underwent vaginal delivery, randomised by hospital to the intervention or to usual care. The intervention was a calibrated blood-collection drape for early detection, a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation) and an implementation strategy. The primary composite outcome and the results are on the existing claim for the bundle (claim-emotive-detection); no finding is repeated here. Registry: lead sponsor University of Birmingham (no organisation record in this atlas yet); enrolment 99,659 (actual), a different basis from the paper, with research participants described as health care providers attending vaginal births; the registry also lists Pakistan, which the paper does not name among its four countries; the study record lists all five, each with the snapshot that names it, and the two sources are not reconciled. The abstract says the trial was funded by the Bill and Melinda Gates Foundation.

Arms

  • E-MOTIVE intervention

    Intervention PPH detection and first-response treatment bundle

    Early detection of postpartum haemorrhage with a calibrated drape, a first-response bundle called MOTIVE (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation) and an implementation strategy.

  • Usual care

    Intervention None named

    Usual care with dissemination of the current guidelines (registry arm description).

Findings

No findings are published for this study.

Record details

Record id
maternal:e-motive-trial
Content hash
7b2a6da37f98700d6f4b56369bd38f246daad299289f37e2046ca414bb656295