Maternal and Perinatal Death Surveillance and Response (MPDSR) ImplementationAMANINCT07560839
Accelerating Maternal and Newborn Survival: The AMANI Study
A study testing Audit and Feedback and Enhanced Mentorship in people with Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation and Maternal Mortality, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality, Neonatal Mortality
- What is being tested?
- Audit and Feedback and Enhanced Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Member of the MPDSR committee
- ≥18 years of age
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Arianna Means, PhD, MPH contact
About this study
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?
Read more
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.
Read the detailed description
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:
- What is the number, proportion, and representativeness of health workers who participate in the practice facilitation package? (Reach)
- What is the effect of the practice facilitation package on maternal, neonatal, and perinatal mortality and MPDSR technical knowledge among facility staff? (Effectiveness)
- What is the number and proportion of deaths for which the MPDSR process is started? (Adoption)
- What is the effect of the practice facilitation intervention on MPDSR implementation with fidelity? What organizational, individual, and intervention characteristics influence the use of MPDSR in facilities? What changes do the facility MPDSR committees make to MPDSR processes? (Implementation)
- What is the proportion of facilities implementing MPDSR with fidelity and the proportion of intervention facilities sustaining each component of the practice facilitation package at 6 and 12 months after withdrawing practice facilitator support? (Maintenance)
- Conditions
- Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality, Neonatal Mortality, Perinatal Mortality
- Being tested
- Audit and Feedback, Enhanced Mentorship
- Keywords
- practice facilitation, RE-AIM, audit and feedback, enhanced mentorship
- Medical subject headings
- Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and FeedbackBehavioural
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.
Enhanced MentorshipBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | The control arm will not receive any interventions. MPDSR committees will continue holding MPDSR meetings as usual for that facility. |
| AMANI Intervention Arm | Experimental | In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package. Receives: Behavioral: Audit and Feedback; Behavioral: Enhanced Mentorship |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to study endline at 3 years
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to study endline (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Maternal and Perinatal Death Surveillance and Response (MPDSR) ImplementationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenyatta National Hospital
- Responsible party
- Principal investigator, Arianna Means, University of Washington
- Investigators
- Arianna Means, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560839
- Sponsor's protocol ID
- STUDY00023958
- Other IDs
- R01HD116777-01
- Acronym
- AMANI
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Abstracted, de-identified patient record data and survey data.
Publications
National Guidelines for Maternal and Perinatal Death Surveillance and Response. Nairobi, Kenya: Kenyan Ministry of Health; 2024.
Baskerville NB, Liddy C, Hogg W. Systematic review and meta-analysis of practice facilitation within primary care settings. Ann Fam Med. 2012 Jan-Feb;10(1):63-74. doi: 10.1370/afm.1312.
PubMed 22230833Willcox ML, Price J, Scott S, Nicholson BD, Stuart B, Roberts NW, Allott H, Mubangizi V, Dumont A, Harnden A. Death audits and reviews for reducing maternal, perinatal and child mortality. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD012982. doi: 10.1002/14651858.CD012982.pub2.
PubMed 32212268Smith H, Ameh C, Godia P, Maua J, Bartilol K, Amoth P, Mathai M, van den Broek N. Implementing Maternal Death Surveillance and Response in Kenya: Incremental Progress and Lessons Learned. Glob Health Sci Pract. 2017 Sep 28;5(3):345-354. doi: 10.9745/GHSP-D-17-00130. Print 2017 Sep 27.
PubMed 28963171Confidentiality Enquiry into Maternal Deaths in Kenya. Ministry of Health Kenya; 2017.
Maputo Plan of Action 2016-2030: Universal Access to Comprehensive Sexual and Reproductive Health Services in Africa. Addis Ababa, Ethiopia: The African Union Commission; 2015.
Kuruvilla S, Bustreo F, Kuo T, Mishra CK, Taylor K, Fogstad H, Gupta GR, Gilmore K, Temmerman M, Thomas J, Rasanathan K, Chaiban T, Mohan A, Gruending A, Schweitzer J, Dini HS, Borrazzo J, Fassil H, Gronseth L, Khosla R, Cheeseman R, Gorna R, McDougall L, Toure K, Rogers K, Dodson K, Sharma A, Seoane M, Costello A. The Global strategy for women's, children's and adolescents' health (2016-2030): a roadmap based on evidence and country experience. Bull World Health Organ. 2016 May 1;94(5):398-400. doi: 10.2471/BLT.16.170431. Epub 2016 May 2. No abstract available.
PubMed 27147772Sharrow D, Hug L, You D, Alkema L, Black R, Cousens S, Croft T, Gaigbe-Togbe V, Gerland P, Guillot M, Hill K, Masquelier B, Mathers C, Pedersen J, Strong KL, Suzuki E, Wakefield J, Walker N; UN Inter-agency Group for Child Mortality Estimation and its Technical Advisory Group. Global, regional, and national trends in under-5 mortality between 1990 and 2019 with scenario-based projections until 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation. Lancet Glob Health. 2022 Feb;10(2):e195-e206. doi: 10.1016/S2214-109X(21)00515-5.
PubMed 35063111
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Maternal and Newborn Survival: The AMANI Study
- ClinicalTrials.gov ID
- NCT07560839
- Acronym / sponsor ID
- AMANI / STUDY00023958
- Conditions
- Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality, Neonatal Mortality, Perinatal Mortality
- Keywords
- practice facilitation, RE-AIM, audit and feedback, enhanced mentorship
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenyatta National Hospital
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- What is the number, proportion, and representativeness of health workers who participate in the practice facilitation package? (Reach)
- What is the effect of the practice facilitation package on maternal, neonatal, and perinatal mortality and MPDSR technical knowledge among facility staff? (Effectiveness)
- What is the number and proportion of deaths for which the MPDSR process is started? (Adoption)
- What is the effect of the practice facilitation intervention on MPDSR implementation with fidelity? What organizational, individual, and intervention characteristics influence the use of MPDSR in facilities? What changes do the facility MPDSR committees make to MPDSR processes? (Implementation)
- What is the proportion of facilities implementing MPDSR with fidelity and the proportion of intervention facilities sustaining each component of the practice facilitation package at 6 and 12 months after withdrawing practice facilitator support? (Maintenance)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –The control arm will not receive any interventions. MPDSR committees will continue holding MPDSR meetings as usual for that facility. |
| AMANI Intervention Arm | Experimental | Behavioral: Audit and Feedback, Behavioral: Enhanced MentorshipIn the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Member of the MPDSR committee
- ≥18 years of age
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit and FeedbackFor 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. | Behavioural | AMANI Intervention Arm |
| Enhanced MentorshipFor 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. | Behavioural | AMANI Intervention Arm |
Primary outcome
MPDSR Fidelity (Implementation)
Time frame: From enrollment to study endline at 3 years
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.
15 secondary outcomes
Reach of the practice facilitation package
Time frame: From enrollment to end of the active intervention phase (2 years)
Institutional Maternal Mortality Ratio (IMMR)
Time frame: From enrollment to study endline (3 years)
Perinatal mortality rate
Time frame: From enrollment to study endline (3 years)
Neonatal mortality rate
Time frame: From enrollment to study endline (3 years)
Adoption
Time frame: From enrollment to study endline (3 years)
Partial MPDSR fidelity
Time frame: From enrollment to study endline (3 years)
Adaptations
Time frame: From enrollment to study endline (3 years)
Maintenance of practice facilitation package
Time frame: From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)
Maintenance of MPDSR
Time frame: From enrollment to study endline (3 years)
Provider technical MPDSR knowledge
Time frame: From enrollment to study endline (3 years)
Attitude towards MPDSR use (Personal motivation)
Time frame: From enrollment to study endline (3 years)
Perceived MPDSR social support (Social motivation)
Time frame: From enrollment to study endline (3 years)
Perceived self-efficacy to perform MPDSR steps (Behavioral skills/fatalism)
Time frame: From enrollment to study endline (3 years)
Psychological safety
Time frame: From enrollment to study endline (3 years)
Provider Burnout
Time frame: From enrollment to study endline (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- BackgroundNational Guidelines for Maternal and Perinatal Death Surveillance and Response. Nairobi, Kenya: Kenyan Ministry of Health; 2024.
- Background: PubMed 22230833Baskerville NB, Liddy C, Hogg W. Systematic review and meta-analysis of practice facilitation within primary care settings. Ann Fam Med. 2012 Jan-Feb;10(1):63-74. doi: 10.1370/afm.1312.
- Background: PubMed 32212268Willcox ML, Price J, Scott S, Nicholson BD, Stuart B, Roberts NW, Allott H, Mubangizi V, Dumont A, Harnden A. Death audits and reviews for reducing maternal, perinatal and child mortality. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD012982. doi: 10.1002/14651858.CD012982.pub2.
- Background: PubMed 28963171Smith H, Ameh C, Godia P, Maua J, Bartilol K, Amoth P, Mathai M, van den Broek N. Implementing Maternal Death Surveillance and Response in Kenya: Incremental Progress and Lessons Learned. Glob Health Sci Pract. 2017 Sep 28;5(3):345-354. doi: 10.9745/GHSP-D-17-00130. Print 2017 Sep 27.
- BackgroundConfidentiality Enquiry into Maternal Deaths in Kenya. Ministry of Health Kenya; 2017.
- BackgroundMaputo Plan of Action 2016-2030: Universal Access to Comprehensive Sexual and Reproductive Health Services in Africa. Addis Ababa, Ethiopia: The African Union Commission; 2015.
- Background: PubMed 27147772Kuruvilla S, Bustreo F, Kuo T, Mishra CK, Taylor K, Fogstad H, Gupta GR, Gilmore K, Temmerman M, Thomas J, Rasanathan K, Chaiban T, Mohan A, Gruending A, Schweitzer J, Dini HS, Borrazzo J, Fassil H, Gronseth L, Khosla R, Cheeseman R, Gorna R, McDougall L, Toure K, Rogers K, Dodson K, Sharma A, Seoane M, Costello A. The Global strategy for women's, children's and adolescents' health (2016-2030): a roadmap based on evidence and country experience. Bull World Health Organ. 2016 May 1;94(5):398-400. doi: 10.2471/BLT.16.170431. Epub 2016 May 2. No abstract available.
- Background: PubMed 35063111Sharrow D, Hug L, You D, Alkema L, Black R, Cousens S, Croft T, Gaigbe-Togbe V, Gerland P, Guillot M, Hill K, Masquelier B, Mathers C, Pedersen J, Strong KL, Suzuki E, Wakefield J, Walker N; UN Inter-agency Group for Child Mortality Estimation and its Technical Advisory Group. Global, regional, and national trends in under-5 mortality between 1990 and 2019 with scenario-based projections until 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation. Lancet Glob Health. 2022 Feb;10(2):e195-e206. doi: 10.1016/S2214-109X(21)00515-5.
- Individual participant dataSharing planned: Yes. Abstracted, de-identified patient record data and survey data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arianna Means, PhD, MPH contact
Arianna Means, PhD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback and Enhanced Mentorship in people with Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation and Maternal Mortality, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Unger, MD, MPH (2066859713, junger@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPDSR Fidelity (Implementation) (time frame: From enrollment to study endline at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07560839, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.