An interventional study of Audit and Feedback and Enhanced Mentorship in Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality and Neonatal Mortality, sponsored by University of Washington. Enrolling by invitation at 1 site in Kenya. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
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:
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.
The AMANI study will take place over three years. During the first two years, practice facilitators will deliver the practice facilitation package with intervention facilities. During the third year, practice facilitators will withdraw from intervention facilities, and both intervention and control facilities will be monitored to understand what elements of practice facilitation and MPDSR are maintained without external support.
Prior to beginning the practice facilitation intervention, a baseline service readiness assessment and data quality audit will be conducted in all enrolled facilities to understand the context of maternal and child healthcare provision at baseline. During the data quality audit, the previous year of facility death and MPDSR documentation will be abstracted from all facilities. During the three years of the AMANI study, facility records will be abstracted from all facilities on a monthly basis.
Within the first question that this study aims to answer, we have several sub-questions:
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 260 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The control arm will not receive any interventions. MPDSR committees will continue holding MPDSR meetings as usual for that facility.
In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.
Behavioral: Audit and Feedback · Behavioral: Enhanced Mentorship
For audit and feedback (component 1), practice facilitators will hold regular meetings with MPDSR committees and facility administrators to present data on facility mortality and MPDSR implementation. Practice facilitators will discuss challenges in MPDSR implementation and help committees engage in quality improvement, including tracking adaptations to the MPDSR process.
For enhanced mentorship (component 2), practice facilitators will attend regular MPDSR committee meetings and provide coaching on navigating data sources and provide information about MPDSR, how to complete quality improvement cycles, and how to problem solve. Practice facilitatorswill also be available for individual mentorship in person or via Zoom/phone call. During meetings, practice facilitators will support the committee to co-develop a tracking system for recommendations made during MPDSR meetings.
MPDSR Fidelity (Implementation)
The number and proportion of maternal and perinatal deaths for which all six MPDSR steps (identify deaths, report deaths, review deaths, recommend solutions, implement recommendations, evaluate recommendations) are implemented in full. Proportions of fully completed MPDSR cycles will be compared between intervention and control arms.
Time frame: From enrollment to study endline at 3 years
Reach of the practice facilitation package
Reach is defined as the proportion of MPDSR committee members who participate in each component of the strategy package (audit and feedback and enhanced mentorship) out of the number of MPDSR committee members in each facility. We will determine if there is a significant difference in participation in each practice facilitation component over time across intervention facilities.
Time frame: From enrollment to end of the active intervention phase (2 years)
Institutional Maternal Mortality Ratio (IMMR)
Number of deaths of pregnant women within 42 days of the termination of pregnancy (from any cause related to or aggravated by the pregnancy or its management), divided by the total of deliveries in the facility over the same period of time. IMMR will be compared between intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Perinatal mortality rate
Number of stillbirths (fetal deaths at least 28 weeks of gestation) and newborn deaths (up to and including the first seven days after birth), divided by the total births in the facility over the same time. Perinatal mortality rate will be compared between intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Neonatal mortality rate
Number of deaths that occur in the first 28 days of life, divided by total live births in the facility over the same period of time. Neonatal mortality rate will be compared between intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Adoption
Adoption is defined as the proportion of deaths at each facility for which the first two steps of the MPDSR cycle are initiated (death was identified). The first two steps include deaths 1) identified and 2) reported with full documentation in maternal death review (MDR), perinatal death review (PDR), and neonatal death review (NDR) data forms within 7 days. Adoption will be considered a binary outcome (yes/no), and adoption will be compared between intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Partial MPDSR fidelity
Proportion of maternal, perinatal, and neonatal deaths for which less than six of the MPDSR steps are implemented, and average number of steps completed, to identify most challenging MPDSR step. Partial fidelity will be compared between intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Adaptations
We will use the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME) to track monthly facility specific adaptations to MPDSR implementation in intervention facilities only and to identify how facilities incorporate MPDSR steps into their practice context and facility infrastructure. Of note, intervention facilities will not be adapting the implementation strategy (AMANI practice facilitation package) and will only be adapting how the MPDSR process is integrated into facility operations. Specifically, we will track the number of modifications made per month to MPDSR implementation, including documentation of the nature of the modification, goal/rationale for modification, timing, and other features.
Time frame: From enrollment to study endline (3 years)
Maintenance of practice facilitation package
Proportion of intervention facilities sustaining audit and feedback and/or enhanced mentorship 6 and 12 months after external PF support is withdrawn. We will determine if there is a significant difference in the prevalence ratio comparing participation in strategy components during the maintenance phase among intervention facilities.
Time frame: From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)
Maintenance of MPDSR
The proportion of maternal and perinatal deaths for which all six MPDSR steps are implemented in full within 3 months, measured 6 and 12 months after external PF support is withdrawn. We will test the effect size of the immediate post-intervention change in fidelity and the overall slope to determine if moving from phase 1 (intervention phase) to phase 2 (maintenance phase) had a meaningful impact on fidelity, comparing intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Provider technical MPDSR knowledge
MPDSR technical knowledge will be measured at baseline, and months 12, 24, 30, and 36 across intervention and control facilities using a brief survey tool. The survey includes 38 questions in 3 domains (MPDSR knowledge, Data sources/forms/processes, and clinical competency), with three to four answer options per question. The total score and domain scores will be compared between intervention and control facilities.
Time frame: From enrollment to study endline (3 years)
Attitude towards MPDSR use (Personal motivation)
Mean responses to four questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Personal motivation will be assessed at baseline, and at months 12, 24, 30, and 36.
Time frame: From enrollment to study endline (3 years)
Perceived MPDSR social support (Social motivation)
Mean responses to five questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Social motivation will be assessed at baseline, and at months 12, 24, 30, and 36.
Time frame: From enrollment to study endline (3 years)
Perceived self-efficacy to perform MPDSR steps (Behavioral skills/fatalism)
Mean responses to six questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Behavioral skills will be assessed at baseline, and at months 12, 24, 30, and 36.
Time frame: From enrollment to study endline (3 years)
Psychological safety
Mean responses to nineteen questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Psychological safety will be assessed at baseline, and at months 12, 24, 30, and 36.
Time frame: From enrollment to study endline (3 years)
Provider Burnout
Provider burnout is assessed with 23 questions using a 5-point Likert scale (never to always). these 23 questions capture four domains: 1) exhaustion (8 questions); 2) mental distance (5 questions); 3) cognitive impairment (5 questions); and 4) emotional impairment (5 questions). Mean domain-specific scores will be calculated and compared between intervention and control facilities. Provider burnout will be assessed at baseline, and at months 12, 24, 30, and 36.
Time frame: From enrollment to study endline (3 years)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Abstracted, de-identified patient record data and survey data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The final versions of any de-identified data collected and/or generated will be made publicly available within 12 months of publication. Data deposited in Dryad is intended to remain permanently archived and available.
Access criteria: Final data gathered from this project will be archived for data sharing purposes in Dryad, NIH's recommended open-access generalist data repository.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2029, 36 months after the start.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's planned 36 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Jul 2026 → Oct 2026, primary completion Jun 2029 → Oct 2029 and completion Jun 2029 → Oct 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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