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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

Short name E-MOTIVE

NCTNCT04341662 (opens ClinicalTrials.gov in a new tab)Other idRG_19-231Other idPACTR202002791391791
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Oxytocin, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
99,659 participants (actual)
Sponsor
University of Birmingham · Other
Design
Randomized · Open label (no masking)
Countries
5 countries

Kenya, Nigeria, Pakistan, South Africa, Tanzania

Start
13 Oct 2020
Primary completion
24 Mar 2023
Completion
24 Mar 2023
First posted
10 Apr 2020
Last update posted
18 Apr 2025
Conditions
Post-Partum Haemorrhage

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202021202220232024
  1. N/A

    E-MOTIVE

    NCT04341662

    13 Oct 2020 to 24 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • E-MOTIVE interventionBehavioral
  • Usual careBehavioral

Arms2

  • Experimental

    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.

  • Active comparator

    Usual care

    Usual care with dissemination of the current guidelines

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

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

    Registry description

    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

Secondary outcomes(20)

  1. PPH Detection

    Time frame · Up to 24 hours postpartum

    Registry description

    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)

  2. Compliance With MOTIVE Bundle

    Time frame · Up to 24 hours postpartum

    Registry description

    Defined as adherence with three core elements of the bundle: administration of oxytocic drugs, TXA and IV fluids. If all three core elements are administered when a PPH is diagnosed, this will be deemed positive for bundle compliance

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

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

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

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

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

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

  6. Number of Women With Hysterectomy Postpartum Until Discharge From the Health Facility

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

  7. Number of Women With Hysterectomy for Bleeding Postpartum Until Discharge From the Health Facility

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

  8. Rate of All Cause Maternal Mortality Postpartum Until Discharge From the Health Facility

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

  9. Amount of Blood Loss (as a Continuous Variable)

    Time frame · Up to 24 hours postpartum

    Registry description

    Reported in millilitres

  10. Number of Women With Primary PPH Defined as Blood Loss ≥500 ml

    Time frame · Up to 24 hours postpartum

    Registry description

    Measured in mililitres

  11. Duration of Hospitalisation Postpartum

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

    Registry description

    Measured in days

  12. Duration of ICU Hospitalisation Postpartum

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

    Registry description

    Measured in days

  13. Number of Women Transferred to a Higher-level Facility Postpartum Until Discharge From the Health Facility

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

  14. Rate of All Cause Neonatal Mortality Postpartum Until Discharge From the Health Facility

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

  15. Number of Women Receiving Non-pneumatic Anti-shock Garment (NASG) Postpartum Until Discharge From the Health Facility

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

  16. Number of Women Receiving Uterine Balloon Tamponade Postpartum Until Discharge From the Health Facility

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

  17. Number of Women Receiving a Blood Transfusion Postpartum Until Discharge From the Health Facility

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

  18. Number of Women Receiving Blood Transfusion for Postpartum Haemorrhage Until Discharge From the Health Facility

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

  19. Number of Women Admitted to Intensive Care Unit (ICU) Until Discharge From the Health Facility

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

  20. Number of Women With Primary Severe PPH (Defined as Blood Loss ≥1000 ml) Following a Vaginal Birth in the Facility Measured up to 2 Hours Postpartum

    Time frame · Up to 2 hours postpartum

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Postpartum until discharge from the health facility (up to 42 days)

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.

GroupValue (Participants)
E-MOTIVE Intervention794
Usual Care2139
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Up to 24 hours postpartum

PPH Detection

GroupValue (Participants)
E-MOTIVE Intervention3,870
Usual Care4,244
Secondary outcomeCount of participants· Up to 24 hours postpartum

Compliance With MOTIVE Bundle

GroupValue (Participants)
E-MOTIVE Intervention3791
Usual Care1623
Secondary outcomeCount of participants· Postpartum until discharge from the health facility (up to 42 days)

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

GroupValue (Participants)
E-MOTIVE Intervention13
Usual Care9
Secondary outcomeCount of participants· 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

GroupValue (Participants)
E-MOTIVE Intervention1
Usual Care1
Secondary outcomeCount of participants· Postpartum until discharge from the healthcare facility (up to 42 days).

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

GroupValue (Participants)
E-MOTIVE Intervention0
Usual Care2
Secondary outcomeCount of participants· Postpartum until discharge from the health facility (up to 42 days).

Number of Women With Hysterectomy Postpartum Until Discharge From the Health Facility

GroupValue (Participants)
E-MOTIVE Intervention11
Usual Care6
Secondary outcomeCount of participants· Postpartum until discharge from the health facility (up to 42 days).

Number of Women With Hysterectomy for Bleeding Postpartum Until Discharge From the Health Facility

GroupValue (Participants)
E-MOTIVE Intervention9
Usual Care6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
E-MOTIVE InterventionThe 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.17 / 49,1017 / 49,1010 / 49,101
Usual CareUsual 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.28 / 50,55832 / 50,5580 / 50,558

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultGallos 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
  • DerivedWilliams 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
  • DerivedForbes 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
  • DerivedAkter 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
  • DerivedBohren 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

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Cluster: Health facility is the randomisation unit. Health facilities are eligible for inclusion if they have 1000 to 5000 births a year and provide comprehensive obstetric care with ability to perform surgery for PPH. Health facilities are selected based on being administratively and geographically distinct from each other. Pre-existing implementation of early detection or bundled approach are exclusion criteria Research participants: All healthcare providers attending vaginal births at the study facilities. Patients: All verified vaginal births in the study facilities

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