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A clinical trial to study the effectiveness of a care bundle to prevent bleeding after a woman has given birth (E-MOTIVE).

Early detection of postpartum haemorrhage and treatment using the World Health Organization MOTIVE ‘first response’ bundle: a cluster randomised trial with health economic analysis and mixed-methods evaluation (E-MOTIVE trial).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202002791391791
Enrollment
80
Registered
2020-02-10
Start date
2020-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Usual care with dissemination of the current guidelines
E MOTIVE care bundle

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Health facilities with pre-existing implementation of early detection or bundled approach are exclusion criteria

Design outcomes

Primary

MeasureTime frame
The primary outcome is a composite of the following three clinical outcomes: 1) Number of women with primary severe PPH defined as blood loss =1000 ml following a vaginal birth in the facility; 2) Number of postpartum laparotomies for bleeding until discharge from the healthcare facility; 3) Number of postpartum maternal deaths from bleeding until discharge from the healthcare facility.

Secondary

MeasureTime frame
Number of women with laparotomy postpartum until discharge from the health facility;Number of women with laparotomy with compression sutures postpartum until discharge from the health facility;Number of women with laparotomy with arterial ligation postpartum until discharge from the health facility;Number of women with hysterectomy postpartum until discharge from the health facility;Number of women with hysterectomy for bleeding postpartum until discharge from the health facility;Rate of all cause maternal mortality postpartum until discharge from the health facility;Rate of all cause neonatal mortality postpartum until discharge from the healthcare facility;Blood loss (reported in ml, as a continuous variable);Number of women with primary PPH defined as blood loss =500 ml;Duration of hospitalisation postpartum;Duration of ICU hospitalisation postpartum;Number of women transferred to a higher-level facility postpartum until discharge from the health facility;Number of women receiving Non-pneumatic anti-shock garment (NASG) postpartum until discharge from the health facility;Number of women receiving uterine balloon tamponade postpartum until discharge from the health facility;Number of women receiving a blood transfusion postpartum until discharge from the health facility;Number of women receiving blood transfusion for postpartum haemorrhage until discharge from the health facility;Number of women admitted to Intensive Care Unit (ICU) until discharge from the health facility;PPH detection (with the following numerator and denominator: women who objectively had PPH (source-verified blood loss = 500 mL after weighing 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);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 P

Countries

Kenya, Nigeria, South Africa, Tanzania

Contacts

Public ContactAdam Devall

Associate Professor

emotive@trials.bham.ac.uk+447971823452

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026