Reproductive, Maternal, Newborn, and Child HealthNCT03371186
Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
A study testing Community Health Worker, Continuous Surveillance and CB-Integrated Management of Newborn and Childhood Illness in people with Reproductive, Maternal, Newborn, and Child Health and Integrated, Community-Health Systems, run by Possible at 2 sites in Nepal.
Trial summary
The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive, Maternal, Newborn, and Child Health, Integrated, Community-Health Systems
- What is being tested?
- Community Health Worker, Continuous Surveillance and CB-Integrated Management of Newborn and Childhood Illness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 2 sitesNepal
- Study dates
- Feb 2016to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Reproductive aged women 15-49;
- Reproductive aged women 15-49; recently delivered in past two years;
- Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
- Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
- Healthcare staff; CHWs serving village clusters, CHW Leaders serving one of the village clusters, Nyaya Health Nepal and Government of Nepal employees involved in study design, program implementation, data collection, or data analysis processes; and
- Must reside in either Achham or Dolakha District, Nepal.
Who cannot join
- Patients meeting inclusion criteria and consenting to study enrollment, as stated above, will be included in the study unless 1) patients migrate from the study are before completion of any of the bundled interventions; 2) patients request exclusion from the study at any point during the bundled intervention.
Trial locations and contacts
2 sites in 1 country.
Duncan Maru, MD, PhD contact
Scott Halliday, MS contact
Nepal2 sites, 2 recruiting
- Recruiting
Charikot Primary Health Center
Bhimeshwor, Dolakha
Aradhana Thapa, MPH, aradhana@possiblehealth.org
Binod Dangal, MD-GP, binod@possiblehealth.org
- Recruiting
Bayalpata Hospital
Sanfebagar, Achham
Aradhana Thapa, MPH, aradhana@possiblehealth.org
Santosh Dhungana, MD-GP, santosh@possiblehealth.org
About this study
The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.
- Being tested
- Community Health Worker, Continuous Surveillance, CB-Integrated Management of Newborn and Childhood Illness, Group Antenatal and Postnatal Care, Balanced Post-Partum Contraceptive Counseling
- Keywords
- Implementation Research, Maternal Mortality and Morbidity, Neonatal Mortality and Morbidity, Infant Mortality and Morbidity, Child Mortality and Morbidity, Community Health Workers, Health Systems Strengthening
- Medical subject headings
- Maternal Death, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerOther
The intervention is designed to address these primary drivers of underutilization of reproductive, maternal, newborn, and child health services in rural Nepal, namely: poverty, lack of social support, and poor birth planning. The investigators have worked with a cadre of Community Healthcare Workers who, in addition to the responsibilities of local community health volunteers, have added responsibilities, training, and managerial support. These women support their community members in their homes to identify and overcome social barriers and plan for emergency healthcare needs. The goals are to increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers
Continuous SurveillanceOther
Each patient identified by a Community Health Worker will undergo a complete diagnostic evaluation by the hospital-based clinicians and will be enrolled in the study only if they are identified as currently pregnant, have recently given birth, or have a child under the age of 24 months. Continuous surveillance systems ensure that the entire population is surveyed every three months and has a three month touchpoint with a Community Health Worker.
CB-Integrated Management of Newborn and Childhood IllnessOther
Safe delivery care; effective neonatal resuscitation; management of childhood diarrhea, malnutrition, and pneumonia; and treatment of traumatic and congenital surgical conditions can reduce child mortality. Community Based Integrated Management of Newborn and Child Illness (CB-IMNCI) has shown substantial reductions in neonatal and early child mortality. Community Health Workers will use CB-IMNCI as the clinical protocol for ongoing care to the community.
Group Antenatal and Postnatal CareOther
The proposed model will change antenatal and pediatric care in three major ways: 1) conduct care in a group setting, 2) provide expert and facilitated peer counseling, and 3) incorporate emergency planning. The group setting is designed to create a supportive social network among women facing similar challenges. The opportunity for counseling beyond the current standard will promote detailed emergency planning and the sharing of context-specific advice from peers to overcome barriers to access care. This intervention draws on the strength within communities of women to change health-seeking behaviors.
Balanced Post-Partum Contraceptive CounselingOther
Research on interventions to improve postpartum contraception suggest strategies that bridge the continuum of reproductive health care-antenatal care, labor and delivery, postnatal care, and infant care-are more effective than short term, stand-alone counseling sessions. The structured counseling module incorporated in the intervention will be partially adapted from the Balanced Counseling Strategy, an interactive contraceptive counseling method developed by the Population Council in accordance with the World Health Organization's tiered effectiveness guidelines. Prior studies in clinical settings in Nepal have demonstrated increased uptake of modern contraceptive methods, especially of long-acting reversible contraceptives with use of balanced counseling.
| Study group | Role | What they receive |
|---|---|---|
| Bundled RMNCH Intervention | Experimental | Stepped wedge, cluster-controlled implementation science trial of 5 bundled intervention components (1. Community Health Worker, 2, Continuous Surveillance, 3. CB-Integrated Management of Newborn and Childhood Illness, 4. Group Antenatal and Postnatal Care, and 5. Balanced Post-Partum Contraceptive Counseling) implemented across 40 village clusters in Achham District, Nepal and 40 village clusters in Dolakha District, Nepal (covering a total population of approximately 300,000) in coordination with district authorities and study staff. The investigators anticipate the experimental arm will enroll approximately 12,000 women and their children over the 18mo enrollment period. Receives: Other: Community Health Worker; Other: Continuous Surveillance; Other: CB-Integrated Management of Newborn and Childhood Illness; Other: Group Antenatal and Postnatal Care; Other: Balanced Post-Partum Contraceptive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Institutional Birth Rate
The percentage of births in a healthcare facility with a healthcare professional present.
Measured: 3 years
Under-Two Mortality Rate
The under-2 mortality rate is the probability (expressed as a rate per 1,000 live births) of a child born in a specified year dying before reaching the age of two if subject to current age-specific mortality rates.
Measured: 3 years
Post-Partum Contraceptive Prevalence Rate
The post-partum contraceptive prevalence rate is number of married reproductive aged women (15-49) in the study population who delivered in the past two years who are using a modern contraceptive method out of the total number of married reproductive aged women (15-49) in the study population who delivered in the past two years.
Measured: 3 years
Secondary outcomes (14)
Home Visit Coverage
The percentage of children under 2 receiving monthly home based care by a CHW out of total number of children under 2 (aggregated by the percentage of pregnant women and reproductive-aged women).
Measured: 3 months
Group Care Content Fidelity
The percentage of topics covered and completed out of total planned topics
Measured: 3 months
Group Participation
The percentage of participants completing group sessions out of total scheduled participants
Measured: 3 months
Session Completion
The percentage of group sessions completed out of total appropriate number of group sessions
Measured: 3 months
First-Trimester Pregnancies Identified
The percentage of pregnancies identified at less than 12 weeks
Measured: 3 months
Antenatal Care Completion
The percentage of women who have had 4 or more antenatal care visits and are eligible for the government financial incentive out of total number of women delivered
Measured: 3 months
Pediatric Pneumonia Incidence
The number of new cases of pneumonia in catchment area in children under age of two/month
Measured: 1 month
Pediatric Diarrhea Incidence
The number of new cases of diarrhea in catchment area in children under age of two/month
Measured: 1 month
Pediatric Stunting Prevalence
The number of cases children in catchment area under age of two whose length-for height or height-for-age is two SDs below WHO Child Growth Standards median/total number of children in catchment area under age of two
Measured: 1 month
Exclusive Breastfeeding Prevalence
The number of infants in catchment area age zero-five months who are exclusively breastfed/total infants in catchment area age zero-five months
Measured: 1 month
Percent of postpartum women with unmet need for contraception
The number of reproductive age women within the first year following the birth of their most recent child who desire to either stop or postpone childbearing for the next 2 years who are not currently using a contraceptive method or have a repeat unintended pregnancy while not using contraception/Total number of women who are up to one year postpartum, excluding women who declare that they are infecund, have had a hysterectomy, or are in menopause
Measured: 3 years
Contraceptive Method Mix
The percentage of women using each method of modern contraception out of total number of women using modern contraception
Measured: 3 months
Total Intervention Cost
The total sum costs of each intervention component
Measured: 3 years
Cost-Effectiveness of Bundled Intervention
The total sum costs of each intervention component over under-2 deaths averted by intervention
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startFeb 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reproductive, Maternal, Newborn, and Child HealthStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Stepped wedge, cluster-controlled implementation science trial
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Possible
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), National Institutes of Health (NIH), Ministry of Health and Population, Nepal, Planned Parenthood League of Massachusetts
- Responsible party
- Sponsor
- Investigators
- Sheela Maru, MD, MPH, Principal investigator, PossiblePushpa Chaudhari, MD, Principal investigator, Ministry of Health and Population, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371186
- Sponsor's protocol ID
- RMNCHnyaya
- Other IDs
- 1DP5OD019894-01, AID-OAA-A-11-0001
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2017
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choudhury N, Wu WJ, Khatri R, Tiwari A, Thapa A, Adhikari S, Basnett I, Bhandari V, Bhatta A, Bogati B, Bhatt LD, Citrin D, Halliday S, Khadka S, Ksetri YKB, Kunwar LB, Magar KR, Marasini N, Maru D, Nirola I, Paudel R, Rai B, Schwarz R, Saud S, Sharma D, Niraula GD, Shrestha R, Thapa P, Rayamazi HJ, Maru S, Sapkota S. "Now that they come to our doorsteps to teach us these things..." - Postpartum contraception outcomes from a pre-post effectiveness-implementation study of an integrated community health worker intervention in rural Nepal. Reprod Health. 2025 Dec 22;22(1):258. doi: 10.1186/s12978-025-02225-5.
PubMed 41430260Maru S, Nirola I, Thapa A, Thapa P, Kunwar L, Wu WJ, Halliday S, Citrin D, Schwarz R, Basnett I, Kc N, Karki K, Chaudhari P, Maru D. An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol. Implement Sci. 2018 Mar 29;13(1):53. doi: 10.1186/s13012-018-0741-x.
PubMed 29598824
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
- ClinicalTrials.gov ID
- NCT03371186
- Acronym / sponsor ID
- RMNCHnyaya
- Keywords
- Implementation Research, Maternal Mortality and Morbidity, Neonatal Mortality and Morbidity, Infant Mortality and Morbidity, Child Mortality and Morbidity, Community Health Workers, Health Systems Strengthening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- PossibleUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), National Institutes of Health (NIH), Ministry of Health and Population, Nepal, Planned Parenthood League of Massachusetts
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 13 Dec 2017 (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 investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge, cluster-controlled implementation science trial
| Arm | Type | Receives |
|---|---|---|
| Bundled RMNCH Intervention | Experimental | Other: Community Health Worker, Other: Continuous Surveillance, Other: CB-Integrated Management of Newborn and Childhood Illness, Other: Group Antenatal and Postnatal Care, Other: Balanced Post-Partum Contraceptive CounselingStepped wedge, cluster-controlled implementation science trial of 5 bundled intervention components (1. Community Health Worker, 2, Continuous Surveillance, 3. CB-Integrated Management of Newborn and Childhood Illness, 4. Group Antenatal and Postnatal Care, and 5. Balanced Post-Partum Contraceptive Counseling) implemented across 40 village clusters in Achham District, Nepal and 40 village clusters in Dolakha District, Nepal (covering a total population of approximately 300,000) in coordination with district authorities and study staff. The investigators anticipate the experimental arm will enroll approximately 12,000 women and their children over the 18mo enrollment period. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Reproductive aged women 15-49;
- Reproductive aged women 15-49; recently delivered in past two years;
- Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
- Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
- Healthcare staff; CHWs serving village clusters, CHW Leaders serving one of the village clusters, Nyaya Health Nepal and Government of Nepal employees involved in study design, program implementation, data collection, or data analysis processes; and
Key exclusion criteria (1 listed)
- Patients meeting inclusion criteria and consenting to study enrollment, as stated above, will be included in the study unless 1) patients migrate from the study are before completion of any of the bundled interventions; 2) patients request exclusion from the study at any point during the bundled intervention.
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 |
|---|---|---|
| Community Health WorkerThe intervention is designed to address these primary drivers of underutilization of reproductive, maternal, newborn, and child health services in rural Nepal, namely: poverty, lack of social support, and poor birth planning. The investigators have worked with a cadre of Community Healthcare Workers who, in addition to the responsibilities of local community health volunteers, have added responsibilities, training, and managerial support. These women support their community members in their homes to identify and overcome social barriers and plan for emergency healthcare needs. The goals are to increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers | Other | Bundled RMNCH Intervention |
| Continuous SurveillanceEach patient identified by a Community Health Worker will undergo a complete diagnostic evaluation by the hospital-based clinicians and will be enrolled in the study only if they are identified as currently pregnant, have recently given birth, or have a child under the age of 24 months. Continuous surveillance systems ensure that the entire population is surveyed every three months and has a three month touchpoint with a Community Health Worker. | Other | Bundled RMNCH Intervention |
| CB-Integrated Management of Newborn and Childhood IllnessSafe delivery care; effective neonatal resuscitation; management of childhood diarrhea, malnutrition, and pneumonia; and treatment of traumatic and congenital surgical conditions can reduce child mortality. Community Based Integrated Management of Newborn and Child Illness (CB-IMNCI) has shown substantial reductions in neonatal and early child mortality. Community Health Workers will use CB-IMNCI as the clinical protocol for ongoing care to the community. | Other | Bundled RMNCH Intervention |
| Group Antenatal and Postnatal CareThe proposed model will change antenatal and pediatric care in three major ways: 1) conduct care in a group setting, 2) provide expert and facilitated peer counseling, and 3) incorporate emergency planning. The group setting is designed to create a supportive social network among women facing similar challenges. The opportunity for counseling beyond the current standard will promote detailed emergency planning and the sharing of context-specific advice from peers to overcome barriers to access care. This intervention draws on the strength within communities of women to change health-seeking behaviors. | Other | Bundled RMNCH Intervention |
| Balanced Post-Partum Contraceptive CounselingResearch on interventions to improve postpartum contraception suggest strategies that bridge the continuum of reproductive health care-antenatal care, labor and delivery, postnatal care, and infant care-are more effective than short term, stand-alone counseling sessions. The structured counseling module incorporated in the intervention will be partially adapted from the Balanced Counseling Strategy, an interactive contraceptive counseling method developed by the Population Council in accordance with the World Health Organization's tiered effectiveness guidelines. Prior studies in clinical settings in Nepal have demonstrated increased uptake of modern contraceptive methods, especially of long-acting reversible contraceptives with use of balanced counseling. | Other | Bundled RMNCH Intervention |
Primary outcome
Institutional Birth Rate
Time frame: 3 years
The percentage of births in a healthcare facility with a healthcare professional present.
Under-Two Mortality Rate
Time frame: 3 years
The under-2 mortality rate is the probability (expressed as a rate per 1,000 live births) of a child born in a specified year dying before reaching the age of two if subject to current age-specific mortality rates.
Post-Partum Contraceptive Prevalence Rate
Time frame: 3 years
The post-partum contraceptive prevalence rate is number of married reproductive aged women (15-49) in the study population who delivered in the past two years who are using a modern contraceptive method out of the total number of married reproductive aged women (15-49) in the study population who delivered in the past two years.
14 secondary outcomes
Home Visit Coverage
Time frame: 3 months
Group Care Content Fidelity
Time frame: 3 months
Group Participation
Time frame: 3 months
Session Completion
Time frame: 3 months
First-Trimester Pregnancies Identified
Time frame: 3 months
Antenatal Care Completion
Time frame: 3 months
Pediatric Pneumonia Incidence
Time frame: 1 month
Pediatric Diarrhea Incidence
Time frame: 1 month
Pediatric Stunting Prevalence
Time frame: 1 month
Exclusive Breastfeeding Prevalence
Time frame: 1 month
Percent of postpartum women with unmet need for contraception
Time frame: 3 years
Contraceptive Method Mix
Time frame: 3 months
Total Intervention Cost
Time frame: 3 years
Cost-Effectiveness of Bundled Intervention
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 41430260Choudhury N, Wu WJ, Khatri R, Tiwari A, Thapa A, Adhikari S, Basnett I, Bhandari V, Bhatta A, Bogati B, Bhatt LD, Citrin D, Halliday S, Khadka S, Ksetri YKB, Kunwar LB, Magar KR, Marasini N, Maru D, Nirola I, Paudel R, Rai B, Schwarz R, Saud S, Sharma D, Niraula GD, Shrestha R, Thapa P, Rayamazi HJ, Maru S, Sapkota S. "Now that they come to our doorsteps to teach us these things..." - Postpartum contraception outcomes from a pre-post effectiveness-implementation study of an integrated community health worker intervention in rural Nepal. Reprod Health. 2025 Dec 22;22(1):258. doi: 10.1186/s12978-025-02225-5.
- Derived from this study: PubMed 29598824Maru S, Nirola I, Thapa A, Thapa P, Kunwar L, Wu WJ, Halliday S, Citrin D, Schwarz R, Basnett I, Kc N, Karki K, Chaudhari P, Maru D. An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol. Implement Sci. 2018 Mar 29;13(1):53. doi: 10.1186/s13012-018-0741-x.
Related trials for Reproductive, Maternal, Newborn, and Child Health
RecruitingObservational study
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Mental Health, Child Wellbeing
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. This study is not recruiting at the moment.
Duncan Maru, MD, PhD contact
Scott Halliday, MS contact
Sheela Maru, MD, MPH principal investigator
Possible
Pushpa Chaudhari, MD principal investigator
Ministry of Health and Population, Nepal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker, Continuous Surveillance and CB-Integrated Management of Newborn and Childhood Illness in people with Reproductive, Maternal, Newborn, and Child Health and Integrated, Community-Health Systems, run by Possible at 2 sites in Nepal.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duncan Maru, MD, PhD (duncan@possiblehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Institutional Birth Rate (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT03371186, which also lists 2 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 10 Sep 2019.