Accelerating Maternal and Newborn Survival: The AMANI Study (NCT07560839) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Accelerating Maternal and Newborn Survival: The AMANI Study
260 participantsStarted 2026-07
Plain-language summary
The goal of this cluster randomized controlled trial is to learn if a practice facilitation package (including both audit and feedback and enhanced mentorship) can increase the use of maternal and perinatal death surveillance and response (MPDSR) in Kenyan health facilities and reduce maternal and perinatal deaths. Twenty facilities will be enrolled (10 intervention; 10 control) and the intervention will be tested with facility staff including the MPDSR committee members and facility administrators. The main questions this study aims to answer are:
* Does the practice facilitation package improve the reach, effectiveness, adoption, implementation, and maintenance of MPDSR in Kenyan health facilities?
* What is the primary pathway through which the practice facilitation package influences MPDSR implementation with fidelity?
Researchers will compare outcomes between the intervention and control facilities to see if the practice facilitation package influences the degree to which facility MPDSR committees can complete all of the steps of the MPDSR process.
Participants in both intervention and control facilities will be asked to respond to short surveys and engage in focus group discussions. Participants in the intervention facilities will be asked to engage regularly with the practice facilitators in enhanced mentorship and audit and feedback.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Member of the MPDSR committee
* ≥18 years of age
Exclusion Criteria:
* None
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on improving how hospitals review and respond to maternal and newborn deaths — since it's not yet recruiting and has no assigned treatment phase, can you help me understand whether this is a systems-improvement study rather than a treatment trial, and what that would mean for my direct care?
2The AMANI study is measuring something called 'MPDSR Fidelity,' which seems to be about how consistently a hospital follows a death review process — would participating in this study change any of the actual treatments or interventions I or my baby would receive?
3Since this trial isn't yet recruiting, are there other currently active studies or standard-of-care improvements at this facility related to reducing maternal or newborn complications that might be more immediately relevant to my situation?
4Given that this study is focused on institutional processes in maternal and perinatal care, does the hospital or clinic where I plan to deliver already participate in any maternal death surveillance programs, and how might that affect the quality of oversight during my care?
5Because this trial targets maternal and neonatal mortality outcomes at a systems level, can you help me understand what it would actually mean for me as a patient to be part of this study — would I be asked to do anything differently, or is the focus mainly on how the care team reviews cases?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MPDSR Fidelity (Implementation)
Timeframe: From enrollment to study endline at 3 years