E-MOTIVE Intervention vs Usual 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.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0162 | 0.0151 | 0.0173 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0423 | 0.0406 | 0.0441 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0261 | -0.0282 | -0.0241 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.382 | 0.353 | 0.414 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.372 | 0.343 | 0.404 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on E-MOTIVE Intervention than on Usual Care | 38.3 | 35.4 | 41.6 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 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. | 794 | 49,101 | OG000 | ClinicalTrials.gov |
| Group 2 | Usual Care | Usual 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. | 2,139 | 50,558 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | 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. | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
| Time frame | Postpartum until discharge from the health facility (up to 42 days) | ClinicalTrials.gov |
| Population | Number of women | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth | ClinicalTrials.gov |
| NCT number | NCT04341662 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Post-Partum Haemorrhage | ClinicalTrials.gov |
| Interventions | E-MOTIVE intervention, Usual care | ClinicalTrials.gov |
| Lead sponsor | University of Birmingham | ClinicalTrials.gov |
| Results first posted | 2024-08-06 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04341662?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.