Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002791391791 Date of Approval: 10/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A clinical trial to study the effectiveness of a care bundle to prevent bleeding after a woman has given birth (E-MOTIVE).
Official scientific title 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).
Brief summary describing the background and objectives of the trial 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 WHO MOTIVE ‘first response’ treatment bundle for PPH on clinical, implementation and resource use outcomes. We will evaluate the implementation through mixed-methods and carry out a health economic evaluation from the public healthcare system perspective. After regulatory approvals, all 80 health facilities will enter a 7-month baseline period in which they will be following usual care with dissemination of the current guidelines. After this 7-month baseline period, we will randomise in a staggered fashion 40 of the 80 health facilities (1:1 ratio) to the E-MOTIVE intervention for 7 months, allowing two months for full implementation and embedding of the intervention. The other 40 health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase. To allow us to perform the randomisation sequentially, if necessary, a minimisation algorithm will ensure a balance of the intervention and control facilities.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) E MOTIVE
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2020
Actual trial start date 13/10/2020
Anticipated date of last follow up 15/06/2023
Actual Last follow-up date 24/03/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 78
Recruitment status Completed
Publication URL www.birmingham.ac.uk/emotive
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care with dissemination of the current guidelines 7 months Control healthcare facilities will receive no specific training, and will continue to monitor blood loss using the non-calibrated blood collection drape as used in the baseline phase and treat PPH under their current guidelines. 40 Active-Treatment of Control Group
Experimental Group E MOTIVE care bundle 7 months 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. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 with pre-existing implementation of early detection or bundled approach are exclusion criteria Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 54 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/03/2020 University of Birmingham Science Technology Engineering and Mathematics committee
Ethics Committee Address
Street address City Postal code Country
Research Support Group, Room 119, Aston Webb Building, University of Birmingham, Edgbaston Birmingham B152TT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2020 KNH UoN Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 19676-00202 Kenyatta National Hospital Nairobi 00202 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2020 National Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki Abuja 0830 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/12/2020 ERB 2 HREC University of Cape Town
Ethics Committee Address
Street address City Postal code Country
G50, Old Main Building, Groote Schuur Hospital Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/03/2020 MUHAS University IRB
Ethics Committee Address
Street address City Postal code Country
Upanga Road Dar es Salaam 65001 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/09/2020 National Health Research Ethics Committee National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive, PO Box 9653 Dar es Salaam 11101 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/03/2021 Tanzania Commission for Science and Technology COSTECH
Ethics Committee Address
Street address City Postal code Country
PO Box 4302, Ali Hassan Mwinyi Road, Kijitonyama Sayansi, COSTECH Building Dar es Salaam 4302 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/06/2020 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Ave, Johannesburg, 2000, South Africa Johannesburg 2000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/10/2020 Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board P.O. Box 27663 Lenana Road Opp. DOD Nairobi 00506 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/02/2021 National Commission for Science Technology and Innovation NACOSTI
Ethics Committee Address
Street address City Postal code Country
off Waiyaki Way, Upper Kabete, P. O. Box 30623, 00100 Nairobi, KENYA Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/02/2022 National Agency for Food and Drug Administration and Control
Ethics Committee Address
Street address City Postal code Country
NAFDAC Corporate Headquarters, Plot 2032, Olusegun, Obasanjo Way, Zone 7, Wuse, Abuja, Nigeria Abuja 2032 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/08/2020 Eastern Cape Department of Health
Ethics Committee Address
Street address City Postal code Country
Department of Health, Bisho, 5605, South Africa Bisho 5605 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/09/2020 KwaZulu Natal Department of Health
Ethics Committee Address
Street address City Postal code Country
Natalia 330 Langalibalele Longmarket Street Pietermaritzburg 3201 Pietermaritzburg 3201 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2022 The Aga Khan University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
National Stadium Rd, Aga Khan University Hospital, Karachi, Karachi City, Sindh, Pakistan Karachi 0000 Pakistan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women with laparotomy postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women with laparotomy with compression sutures postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days.
Secondary Outcome 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 Outcome Number of women with hysterectomy postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women with hysterectomy for bleeding postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Rate of all cause maternal mortality postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Rate of all cause neonatal mortality postpartum until discharge from the healthcare facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Blood loss (reported in ml, as a continuous variable) Up to 2 hours postpartum or up to 24 hours if bleeding continues
Secondary Outcome Number of women with primary PPH defined as blood loss ≥500 ml Up to 2 hours postpartum or up to 24 hours if bleeding continues
Secondary Outcome Duration of hospitalisation postpartum Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Duration of ICU hospitalisation postpartum Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women transferred to a higher-level facility postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women receiving Non-pneumatic anti-shock garment (NASG) postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women receiving uterine balloon tamponade postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women receiving a blood transfusion postpartum until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women receiving blood transfusion for postpartum haemorrhage until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome Number of women admitted to Intensive Care Unit (ICU) until discharge from the health facility Postpartum until discharge from the healthcare facility - up to 42 days
Secondary Outcome 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) Up to 2 hours postpartum
Secondary Outcome 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 PPH by the birth attendants divided by the total number of women who objectively had PPH (blood loss ≥ 500 mL after weighing of the drape) Up to 2 hours postpartum
Secondary Outcome Number of women receiving uterine massage for PPH Up to 24 hours postpartum
Secondary Outcome Number of women receiving Oxytocin for PPH Up to 24 hours postpartum
Secondary Outcome Number of women receiving Misoprostol for PPH Up to 24 hours postpartum
Secondary Outcome Number of women receiving TXA for PPH Up to 24 hours postpartum
Secondary Outcome Number of women receiving Intravenous fluids (IV) for PPH Up to 24 hours postpartum
Secondary Outcome Number of women receiving examination of the genital tract Up to 24 hours postpartum
Secondary Outcome Number of women receiving any treatment uterotonic for PPH Up to 24 hours postpartum
Secondary Outcome Number of vaginal births per week Throughout the trial - up to 3 years
Secondary Outcome Number of caesarean sections per week Throughout the trial - up to 3 years
Secondary Outcome Availability of bundle components on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Availability of non-pneumatic anti-shock garment on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Availability of uterine balloon tamponade on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Availability of blood transfusion on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Availability of surgical theatre for obstetrics on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Availability of intensive care unit on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Availability of skilled birth attendants on a monthly basis Throughout the trial - up to 3 years
Secondary Outcome Number of women requiring additional treatment interventions (not responding to the MOTIVE bundle) Up to 24 hours postpartum
Secondary Outcome PPH treatment (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 24 hours postpartum
Secondary Outcome Bundle usage (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 24 hours postpartum
Secondary Outcome Bundle usage for PPH (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 24 hours postpartum
Secondary Outcome 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 Outcome Postpartum laparotomy for bleeding until discharge from the health facility Until discharge from the health facility - up to 42 days
Secondary Outcome Postpartum maternal death from bleeding until discharge from the health facility Until discharge from the health facility - up to 42 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Cape Town University of Cape Town Cape Town South Africa
Bayero University Bayero University Kano Nigeria
Muhimbili University of Health and Allied Sciences United Nations Rd Dar es Salaaam Tanzania
University of Nairobi University of Nairobi Nairobi Kenya
University of the Witwatersrand 1 Jan Smuts Ave Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Birmingham Research Support Group, Room 119, Aston Webb Building, University of Birmingham, Edgbaston Birmingham 1520 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr Fabiana Lorencatto UCL Centre for Behaviour Change Room 504, Alexandra House, 17-19 Queen Square, WC1N 3AZ London United Kingdom
Dr Meghan Bohren School of Population and Global Health, University of Melbourne Melbourne Australia
Prof Suellen Miller Dept Obstetrics Gynecology and Reproductive Sciences, Bixby Center for Global Reproductive Health and Policy, University of California San Francisco United States of America
Dr Fernando Althabe Department of Reproductive Health and Research, World Health Organization Geneva Switzerland
Dr Ilias Goranitis Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne Australia
Prof Andrew Shennan Womens Academic Health Centre, Kings College London London United Kingdom
Prof Andrew Weeks Womens and Childrens Health, University of Liverpool Liverpool United Kingdom
Dr Cherrie Evans Helping Mothers Survive, Jhpiego, John Hopkins University Baltimore United States of America
Dr Metin Gulmezoglu Concept Foundation, Batiment F2F3, Avenue de Secheron 15 Geneva Switzerland
Prof Zahida Qureshi Department of Obstetrics and Gynaecology, University of Nairobi Nairobi Kenya
Prof Sue Fawcus Department of Obstetrics and Gynaecology, University of Cape Town Cape Town South Africa
Prof Justus Hofmeyr University of the Witwatersrand East London South Africa
Prof Hadiza Galadanci Bayero University Kano Nigeria
Dr Fadhlun Alwy Al Beity Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences Dar es Salaam Tanzania
Prof Tracy Roberts Health Economics Unit, Institute of Applied Health Research, University of Birmingham Birmingham United Kingdom
Dr Lumaan Sheikh The Aga Khan University Karachi Pakistan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Arri Coomarasamy a.coomarasamy@bham.ac.uk +441213718202 Institute of Metabolism and Systems Research, University of Birmingham, B15 2TT
City Postal code Country Position/Affiliation
Birmingham United Kingdom Professor of Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Ioannis Gallos gallosi@who.int +41795408368 Av. Appia 20
City Postal code Country Position/Affiliation
Geneva Switzerland Medical Officer
Role Name Email Phone Street address
Public Enquiries Adam Devall emotive@trials.bham.ac.uk +447971823452 Institute of Metabolism and Systems Research, University of Birmingham, B15 2TT
City Postal code Country Position/Affiliation
Birmingham United Kingdom Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All collected data fields will be made available for any IPD analyses. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be made available after the primary publication of the data The access will be controlled and permission granted by the Trial Management Group. All reasonable requests for use of the data will be permitted.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.birmingham.ac.uk/emotive Yes 05/06/2023 09/05/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/06/2023 Result - 05/06/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.birmingham.ac.uk/documents/college-mds/trials/bctu/e-motive/e-motive-protocol-v6.0-clean.pdf
Changes to trial information