Post-Partum Haemorrhage Clinical Trial
— E-MOTIVEOfficial title:
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)
| Verified date | March 2023 |
| Source | University of Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 210132 |
| Est. completion date | March 24, 2023 |
| Est. primary completion date | March 24, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Kenya | University of Nairobi | Nairobi | |
| Nigeria | Bayero University | Kano | |
| South Africa | University of Cape Town | Cape Town | |
| South Africa | University of the Witwatersrand | Johannesburg | |
| Tanzania | Muhimbili University of Health and Allied Sciences | Dar Es Salaam |
| Lead Sponsor | Collaborator |
|---|---|
| University of Birmingham | Ammalife, Bayero University Kano, Nigeria, Concept Foundation, Jhpiego, King's College London, Muhimbili University of Health and Allied Sciences, The Aga Khan University, University College, London, University of California, University of Cape Town, University of Liverpool, University of Melbourne, University of Nairobi, University of Witwatersrand, South Africa, World Health Organization |
Kenya, Nigeria, South Africa, Tanzania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of vaginal births per week | Throughout the trial (up to 3 years). | ||
| Other | Number of caesarean sections per week | Throughout the trial (up to 3 years). | ||
| Other | Availability of bundle components on a monthly basis | Through completion of monthly facility form (assessing stock levels). | Throughout the trial (up to 3 years). | |
| Other | Availability of non-pneumatic anti-shock garment (NASG) on a monthly basis | Through completion of monthly facility form (assessing stock levels). | Throughout the trial (up to 3 years). | |
| Other | Availability of uterine balloon tamponade on a monthly basis | Through completion of monthly facility form (assessing stock levels). | Throughout the trial (up to 3 years). | |
| Other | Availability of blood transfusion on a monthly basis | Through completion of monthly facility form (assessing stock levels). | Throughout the trial (up to 3 years). | |
| Other | Availability of surgical theatre for obstetrics on a monthly basis | Through completion of monthly facility form (assessing availability). | Throughout the trial (up to 3 years). | |
| Other | Availability of intensive care unit on a monthly basis | Through completion of monthly facility form (assessing availability). | Throughout the trial (up to 3 years). | |
| Other | Availability of skilled birth attendants on a monthly basis | Through completion of monthly facility form (assessing availability). | Throughout the trial (up to 3 years). | |
| 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. | 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
Number of women with postpartum laparotomy for bleeding until discharge from the health facility 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 |
Postpartum until discharge from the health facility (up to 42 days) | |
| Secondary | 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) | Up to 24 hours postpartum | |
| Secondary | 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 | Up to 24 hours postpartum | |
| Secondary | Number of women with laparotomy postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days) | ||
| Secondary | Number of women with laparotomy with compression sutures postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women with laparotomy with arterial ligation postpartum until discharge from the health facility | Postpartum until discharge from the healthcare facility (up to 42 days). | ||
| Secondary | Number of women with hysterectomy postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women with hysterectomy for bleeding postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Rate of all cause maternal mortality postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Amount of blood loss (as a continuous variable) | Reported in millilitres | Up to 24 hours postpartum | |
| Secondary | Number of women with primary PPH defined as blood loss =500 ml | Measured in mililitres | Up to 24 hours postpartum | |
| Secondary | Duration of hospitalisation postpartum | Measured in days | Postpartum until discharge from the health facility (up to 42 days). | |
| Secondary | Duration of ICU hospitalisation postpartum | Measured in days | Postpartum until discharge from the health facility (up to 42 days). | |
| Secondary | Number of women transferred to a higher-level facility postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Rate of all cause neonatal mortality postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women receiving Non-pneumatic anti-shock garment (NASG) postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women receiving uterine balloon tamponade postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women receiving a blood transfusion postpartum until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women receiving blood transfusion for postpartum haemorrhage until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Number of women admitted to Intensive Care Unit (ICU) until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| 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 | Up to 2 hours postpartum | ||
| Secondary | Postpartum laparotomy for bleeding until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | Postpartum maternal death from bleeding until discharge from the health facility | Postpartum until discharge from the health facility (up to 42 days). | ||
| Secondary | 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 | Up to 2 hours postpartum (or up to 24 hours if bleeding continues) | |
| Secondary | 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 | Up to 2 hours postpartum (or up to 24 hours if bleeding continues) | |
| Secondary | 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 | Up to 2 hours postpartum (or up to 24 hours if bleeding continues) | |
| Secondary | Number of women receiving uterine massage for PPH | Up to 24 hours postpartum | ||
| Secondary | Number of women receiving Oxytocin for PPH | Up to 24 hours postpartum | ||
| Secondary | Number of women receiving Misoprostol for PPH | Up to 24 hours postpartum | ||
| Secondary | Number of women receiving TXA for PPH | Up to 24 hours postpartum | ||
| Secondary | Number of women receiving Intravenous fluids (IV) for PPH | Up to 24 hours postpartum | ||
| Secondary | Number of women receiving examination of the genital tract | Physical observation (no specific tool used). | Up to 24 hours postpartum | |
| Secondary | Number of women receiving any treatment uterotonic for PPH | Up to 24 hours postpartum | ||
| Secondary | Number of women requiring additional treatment interventions (not responding to the MOTIVE bundle). | Up to 24 hours postpartum |