N/A
N=99,659
A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth
Post-Partum Haemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT04341662 ↗Enrolled (actual)
99,659
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: 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. — 794; 2139 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- E-MOTIVE intervention (Behavioral); Usual care (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Birmingham
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
794; 2139 | — |
| SECONDARY PPH Detection |
3,870; 4,244 | — |
| SECONDARY Compliance With MOTIVE Bundle |
3791; 1623 | — |
| SECONDARY Number of Women With Laparotomy Postpartum Until Discharge From the Health Facility |
13; 9 | — |
| SECONDARY Number of Women With Laparotomy With Compression Sutures Postpartum Until Discharge From the Health Facility |
1; 1 | — |
| SECONDARY Number of Women With Laparotomy With Arterial Ligation Postpartum Until Discharge From the Health Facility |
0; 2 | — |
| SECONDARY Number of Women With Hysterectomy Postpartum Until Discharge From the Health Facility |
11; 6 | — |
| SECONDARY Number of Women With Hysterectomy for Bleeding Postpartum Until Discharge From the Health Facility |
9; 6 | — |
| SECONDARY Rate of All Cause Maternal Mortality Postpartum Until Discharge From the Health Facility |
17; 28 | — |
| SECONDARY Amount of Blood Loss (as a Continuous Variable) |
160; 220 | — |
| SECONDARY Number of Women With Primary PPH Defined as Blood Loss ≥500 ml |
4,158; 8,351 | — |
| SECONDARY Duration of Hospitalisation Postpartum |
1; 1 | — |
| SECONDARY Duration of ICU Hospitalisation Postpartum |
1; 1 | — |
| SECONDARY Number of Women Transferred to a Higher-level Facility Postpartum Until Discharge From the Health Facility |
85; 18 | — |
| SECONDARY Rate of All Cause Neonatal Mortality Postpartum Until Discharge From the Health Facility |
2259; 2233 | — |
| SECONDARY Number of Women Receiving Non-pneumatic Anti-shock Garment (NASG) Postpartum Until Discharge From the Health Facility |
90; 38 | — |
| SECONDARY Number of Women Receiving Uterine Balloon Tamponade Postpartum Until Discharge From the Health Facility |
44; 57 | — |
| SECONDARY Number of Women Receiving a Blood Transfusion Postpartum Until Discharge From the Health Facility |
1074; 1296 | — |
| SECONDARY Number of Women Receiving Blood Transfusion for Postpartum Haemorrhage Until Discharge From the Health Facility |
580; 944 | — |
| SECONDARY Number of Women Admitted to Intensive Care Unit (ICU) Until Discharge From the Health Facility |
7; 32 | — |
| SECONDARY 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 |
786; 2,129 | — |
| SECONDARY Postpartum Laparotomy for Bleeding Until Discharge From the Health Facility |
12; 7 | — |
| SECONDARY Postpartum Maternal Death From Bleeding Until Discharge From the Health Facility |
12; 18 | — |
| SECONDARY PPH Treatment by Healthcare Provider up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues) |
5921; 4899 | — |
| SECONDARY Bundle Usage up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues) |
5,783; 1,725 | — |
| SECONDARY Bundle Usage for PPH up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues) |
5783; 1725 | — |
| SECONDARY Number of Women Receiving Uterine Massage for PPH |
5794; 4119 | — |
| SECONDARY Number of Women Receiving Oxytocin for PPH |
5897; 4321 | — |
| SECONDARY Number of Women Receiving Misoprostol for PPH |
2601; 2732 | — |
| SECONDARY Number of Women Receiving TXA for PPH |
5829; 1983 | — |
| SECONDARY Number of Women Receiving Intravenous Fluids (IV) for PPH |
5884; 4199 | — |
| SECONDARY Number of Women Receiving Examination of the Genital Tract |
5506; 3608 | — |
| SECONDARY Number of Women Receiving Any Treatment Uterotonic for PPH |
5909; 4541 | — |
| SECONDARY Number of Women Requiring Additional Treatment Interventions (Not Responding to the MOTIVE Bundle). |
219; 637 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04341662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.