CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99,659 enrolled
Drug / intervention
E-MOTIVE intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04341662
NCT04341662N/ACompleted

Early Detection of Postpartum Haemorrhage and Treatment Using the World Health Organisation MOTIVE 'First Response' Bundle: a Cluster Randomised Trial With Health Economic Analysis and Mixed-methods Evaluation (E-MOTIVE Trial)

University of Birmingham·interventional·Posted Apr 10, 2020·Updated Apr 18, 2025

In Brief

A clinical study evaluating E-MOTIVE intervention and Usual care for Post-Partum Haemorrhage. Completed, enrolled 99,659 participants across 6 sites in 5 countries.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 10, 2020
Enrollment StartOct 13, 2020
Primary CompletionMar 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.2 years ago

Interventions

E-MOTIVE interventionbehavioral

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 carebehavioral

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