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CompletedNCT04341662E-MOTIVEUpdated Apr 18, 2025Results posted

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

An interventional study of E-MOTIVE intervention and Usual care in Post-Partum Haemorrhage, sponsored by University of Birmingham. Completed at 6 sites in 5 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by University of Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
99,659
Allocation
Randomized
Sex
Female
01

Study 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.

Read the detailed description

The aim of this trial is evaluate the implementation of early detection and the use of the WHO MOTIVE 'first response' treatment bundle for 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. The investigators will use a multi-country, parallel cluster randomised trial design with a baseline control phase, along with mixed-methods and health economic evaluations. The trial is conducted in secondary level health facilities in four low- and middle- income countries. For this trial, the 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. Pre-existing implementation of early detection or bundled approach are exclusion criteria. The research participants are all healthcare providers attending vaginal births in the study facilities. 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. The control health facilities will deliver usual care with dissemination of the current guidelines.

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.

02

Conditions studied

  • Post-Partum Haemorrhage

Keywords

  • post-partum haemorrhage
  • early detection
  • blood loss measurement
  • oxytocin
  • tranexamic acid
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 99,659 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

University of Birmingham is the lead sponsor of 179 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99,659 participants (actual)

Study arms

  • 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.

    Behavioral: E-MOTIVE intervention

  • Active comparator
    Usual care

    Usual care with dissemination of the current guidelines

    Behavioral: Usual care

Interventions

  • BehavioralE-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.

  • BehavioralUsual care

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

06

What researchers measure

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

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

Secondary outcomes

  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)

    Time frame: Up to 24 hours postpartum

  2. Compliance With MOTIVE Bundle

    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

    Time frame: Up to 24 hours postpartum

  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)

    Reported in millilitres

    Time frame: Up to 24 hours postpartum

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

    Measured in mililitres

    Time frame: Up to 24 hours postpartum

  11. Duration of Hospitalisation Postpartum

    Measured in days

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

  12. Duration of ICU Hospitalisation Postpartum

    Measured in days

    Time frame: Postpartum until discharge from the health facility (up to 42 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

  21. Postpartum Laparotomy for Bleeding Until Discharge From the Health Facility

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

  22. Postpartum Maternal Death From Bleeding Until Discharge From the Health Facility

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

  23. PPH Treatment by Healthcare Provider up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)

    With the following numerator and denominator: women diagnosed with PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility

    Time frame: Up to 2 hours postpartum (or up to 24 hours if bleeding continues)

  24. Bundle Usage up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)

    With the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility

    Time frame: Up to 2 hours postpartum (or up to 24 hours if bleeding continues)

  25. Bundle Usage for PPH up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)

    With the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendant divided by the total of women diagnosed with PPH by the birth attendants

    Time frame: Up to 2 hours postpartum (or up to 24 hours if bleeding continues)

  26. Number of Women Receiving Uterine Massage for PPH

    Time frame: Up to 24 hours postpartum

  27. Number of Women Receiving Oxytocin for PPH

    Time frame: Up to 24 hours postpartum

  28. Number of Women Receiving Misoprostol for PPH

    Time frame: Up to 24 hours postpartum

  29. Number of Women Receiving TXA for PPH

    Time frame: Up to 24 hours postpartum

  30. Number of Women Receiving Intravenous Fluids (IV) for PPH

    Time frame: Up to 24 hours postpartum

  31. Number of Women Receiving Examination of the Genital Tract

    Physical observation (no specific tool used).

    Time frame: Up to 24 hours postpartum

  32. Number of Women Receiving Any Treatment Uterotonic for PPH

    Time frame: Up to 24 hours postpartum

  33. Number of Women Requiring Additional Treatment Interventions (Not Responding to the MOTIVE Bundle).

    Time frame: Up to 24 hours postpartum

07

Results

Posted Aug 6, 2024
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.

Participant flow

Participant flow — Overall Study
MilestoneE-MOTIVE InterventionUsual Care
Started4910150558
Completed4867850044
Not completed423514
Withdrew: Did not have source-verified blood loss data423514

Outcome measures

PrimaryThe 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

Time frame:
Postpartum until discharge from the health facility (up to 42 days)
Reported as:
Count of participants · Participants
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.
ParticipantsE-MOTIVE InterventionUsual Care
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.7942139
SecondaryPPH 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)

Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
PPH Detection
ParticipantsE-MOTIVE InterventionUsual Care
PPH Detection3,8704,244
SecondaryCompliance With MOTIVE Bundle

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

Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Compliance With MOTIVE Bundle
ParticipantsE-MOTIVE InterventionUsual Care
Compliance With MOTIVE Bundle37911623
SecondaryNumber of Women With Laparotomy Postpartum Until Discharge From the Health Facility
Time frame:
Postpartum until discharge from the health facility (up to 42 days)
Reported as:
Count of participants · Participants
Number of Women With Laparotomy Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women With Laparotomy Postpartum Until Discharge From the Health Facility139
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women With Laparotomy With Compression Sutures Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women With Laparotomy With Compression Sutures Postpartum Until Discharge From the Health Facility11
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women With Laparotomy With Arterial Ligation Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women With Laparotomy With Arterial Ligation Postpartum Until Discharge From the Health Facility02
SecondaryNumber of Women With Hysterectomy Postpartum Until Discharge From the Health Facility
Time frame:
Postpartum until discharge from the health facility (up to 42 days).
Reported as:
Count of participants · Participants
Number of Women With Hysterectomy Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women With Hysterectomy Postpartum Until Discharge From the Health Facility116
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women With Hysterectomy for Bleeding Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women With Hysterectomy for Bleeding Postpartum Until Discharge From the Health Facility96
SecondaryRate 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).
Reported as:
Count of participants · Participants
Rate of All Cause Maternal Mortality Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Rate of All Cause Maternal Mortality Postpartum Until Discharge From the Health Facility1728
SecondaryAmount of Blood Loss (as a Continuous Variable)

Reported in millilitres

Time frame:
Up to 24 hours postpartum
Reported as:
Median · Millilitres
Amount of Blood Loss (as a Continuous Variable)
MillilitresE-MOTIVE InterventionUsual Care
Amount of Blood Loss (as a Continuous Variable)160 (100 to 280)220 (120 to 380)
SecondaryNumber of Women With Primary PPH Defined as Blood Loss ≥500 ml

Measured in mililitres

Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women With Primary PPH Defined as Blood Loss ≥500 ml
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women With Primary PPH Defined as Blood Loss ≥500 ml4,1588,351
SecondaryDuration of Hospitalisation Postpartum

Measured in days

Time frame:
Postpartum until discharge from the health facility (up to 42 days).
Reported as:
Median · Days
Duration of Hospitalisation Postpartum
DaysE-MOTIVE InterventionUsual Care
Duration of Hospitalisation Postpartum1 (0 to 1)1 (0 to 1)
SecondaryDuration of ICU Hospitalisation Postpartum

Measured in days

Time frame:
Postpartum until discharge from the health facility (up to 42 days).
Reported as:
Median · Days
Duration of ICU Hospitalisation Postpartum
DaysE-MOTIVE InterventionUsual Care
Duration of ICU Hospitalisation Postpartum1 (0 to 3)1 (1 to 2)
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women Transferred to a Higher-level Facility Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Transferred to a Higher-level Facility Postpartum Until Discharge From the Health Facility8518
SecondaryRate 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).
Reported as:
Count of participants · Participants
Rate of All Cause Neonatal Mortality Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Rate of All Cause Neonatal Mortality Postpartum Until Discharge From the Health Facility22592233
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women Receiving Non-pneumatic Anti-shock Garment (NASG) Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Non-pneumatic Anti-shock Garment (NASG) Postpartum Until Discharge From the Health Facility9038
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women Receiving Uterine Balloon Tamponade Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Uterine Balloon Tamponade Postpartum Until Discharge From the Health Facility4457
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women Receiving a Blood Transfusion Postpartum Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving a Blood Transfusion Postpartum Until Discharge From the Health Facility10741296
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women Receiving Blood Transfusion for Postpartum Haemorrhage Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Blood Transfusion for Postpartum Haemorrhage Until Discharge From the Health Facility580944
SecondaryNumber 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).
Reported as:
Count of participants · Participants
Number of Women Admitted to Intensive Care Unit (ICU) Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Admitted to Intensive Care Unit (ICU) Until Discharge From the Health Facility732
SecondaryNumber 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
Reported as:
Count of participants · Participants
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
ParticipantsE-MOTIVE InterventionUsual Care
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 Postpartum7862,129
SecondaryPostpartum Laparotomy for Bleeding Until Discharge From the Health Facility
Time frame:
Postpartum until discharge from the health facility (up to 42 days).
Reported as:
Count of participants · Participants
Postpartum Laparotomy for Bleeding Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Postpartum Laparotomy for Bleeding Until Discharge From the Health Facility127
SecondaryPostpartum Maternal Death From Bleeding Until Discharge From the Health Facility
Time frame:
Postpartum until discharge from the health facility (up to 42 days).
Reported as:
Count of participants · Participants
Postpartum Maternal Death From Bleeding Until Discharge From the Health Facility
ParticipantsE-MOTIVE InterventionUsual Care
Postpartum Maternal Death From Bleeding Until Discharge From the Health Facility1218
SecondaryPPH Treatment by Healthcare Provider up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)

With the following numerator and denominator: women diagnosed with PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility

Time frame:
Up to 2 hours postpartum (or up to 24 hours if bleeding continues)
Reported as:
Count of participants · Participants
PPH Treatment by Healthcare Provider up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)
ParticipantsE-MOTIVE InterventionUsual Care
PPH Treatment by Healthcare Provider up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)59214899
SecondaryBundle Usage up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)

With the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility

Time frame:
Up to 2 hours postpartum (or up to 24 hours if bleeding continues)
Reported as:
Count of participants · Participants
Bundle Usage up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)
ParticipantsE-MOTIVE InterventionUsual Care
Bundle Usage up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)5,7831,725
SecondaryBundle Usage for PPH up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)

With the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendant divided by the total of women diagnosed with PPH by the birth attendants

Time frame:
Up to 2 hours postpartum (or up to 24 hours if bleeding continues)
Reported as:
Count of participants · Participants
Bundle Usage for PPH up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)
ParticipantsE-MOTIVE InterventionUsual Care
Bundle Usage for PPH up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)57831725
SecondaryNumber of Women Receiving Uterine Massage for PPH
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving Uterine Massage for PPH
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Uterine Massage for PPH57944119
SecondaryNumber of Women Receiving Oxytocin for PPH
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving Oxytocin for PPH
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Oxytocin for PPH58974321
SecondaryNumber of Women Receiving Misoprostol for PPH
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving Misoprostol for PPH
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Misoprostol for PPH26012732
SecondaryNumber of Women Receiving TXA for PPH
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving TXA for PPH
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving TXA for PPH58291983
SecondaryNumber of Women Receiving Intravenous Fluids (IV) for PPH
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving Intravenous Fluids (IV) for PPH
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Intravenous Fluids (IV) for PPH58844199
SecondaryNumber of Women Receiving Examination of the Genital Tract

Physical observation (no specific tool used).

Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving Examination of the Genital Tract
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Examination of the Genital Tract55063608
SecondaryNumber of Women Receiving Any Treatment Uterotonic for PPH
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Receiving Any Treatment Uterotonic for PPH
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Receiving Any Treatment Uterotonic for PPH59094541
SecondaryNumber of Women Requiring Additional Treatment Interventions (Not Responding to the MOTIVE Bundle).
Time frame:
Up to 24 hours postpartum
Reported as:
Count of participants · Participants
Number of Women Requiring Additional Treatment Interventions (Not Responding to the MOTIVE Bundle).
ParticipantsE-MOTIVE InterventionUsual Care
Number of Women Requiring Additional Treatment Interventions (Not Responding to the MOTIVE Bundle).219637

Adverse events

Collected over As the interventions being tested as a bundle in this trial are recommended and used throughout the world, there are no adverse events which would be anticipated as a unique consequence of participation in the trial. No expedited reporting of adverse events is proposed. Maternal deaths and ICU admissions were collected until discharge from the health facility (up to 42 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
E-MOTIVE Intervention17/49,101 (0%)7/49,101 (0%)0/49,101 (0%)
Usual Care28/50,558 (0.1%)32/50,558 (0.1%)0/50,558 (0%)
Most frequent serious events
Most frequent serious events
EventE-MOTIVE InterventionUsual Care
Admission to ICUPregnancy, puerperium and perinatal conditions7/4910132/50558

Baseline characteristics

The numbers provided are for patients however the participant flow refers to clusters (hospitals)

Age, Continuous
Age, Continuous(years)E-MOTIVE InterventionUsual CareTotal
Median26 (21 to 31)26 (21 to 30)26 (21 to 31)
Sex: Female, Male
Sex: Female, Male(Participants)E-MOTIVE InterventionUsual CareTotal
Female491015055899659
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)E-MOTIVE InterventionUsual CareTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)E-MOTIVE InterventionUsual CareTotal
Tanzania106581062721285
South Africa9668903018698
Kenya11475999221467
Nigeria173002090938209
08

Study locations

6 sites
  • 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
09

References and documents

Publications

  • 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. PubMed 37158447 ↗
  • 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. PubMed 34261508 ↗

Related links

Study documents

  • Study protocol · Jul 24, 2023
  • Statistical analysis plan · Mar 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All collected IPD

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04341662
Lead sponsor
University of Birmingham
Collaborators
University College, London, University of Melbourne, University of California, World Health Organization, King's College London, University of Liverpool, Jhpiego, Concept Foundation, University of Nairobi, University of Cape Town, Bayero University Kano, Nigeria, Muhimbili University of Health and Allied Sciences, University of Witwatersrand, South Africa, Ammalife, Aga Khan University
Responsible party
Sponsor
First posted
Apr 10, 2020
Start date
Oct 13, 2020
Primary completion
Mar 24, 2023
Completion
Mar 24, 2023
Results posted
Aug 6, 2024
Last update
Apr 18, 2025

Study contacts

Arri Coomarasamy, MD
principal investigator · University of Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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