Maternal and Child HealthNCT02726230
Bihar Family Health Initiative (Ananya)
A study testing Ananya in people with Maternal and Child Health, run by University of California, San Diego.
Trial summary
Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal and Child Health
- What is being tested?
- Ananya
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,633 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Apr 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers of infants 0-23 months residing in the catchment area of the subcenters (public health facilities) included in this study.
Who cannot join
None listed.
About this study
Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to increase maternal and neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal districts in western and central Bihar.received Ananya, while 30 districts did not. Data were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess Ananya outcome effects in this quasi experimental study.
- Conditions
- Maternal and Child Health
- Being tested
- Ananya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnanyaBehavioural
The Ananya program was developed and implemented via a partnership of the Bill and Melinda Gates Foundation and the Government of Bihar as a means of improving reproductive, maternal, newborn and child health (RMNCH) outcomes in the state, in particular focusing on improving health behaviors and service utilization in the final trimester of pregnancy and early postpartum period. Ananya was designed as a series of supply- and demand-side efforts to improve health. Efforts were focused on strengthening outreach services in quantity and quality, improving quality of facility services, and mobilizing communities to improve health behaviors. The Ananya program included training, mobilizing, and monitoring of government frontline health workers (FLWs, including anganwadi workers- AWWS, auxiliary nurse midwives- ANMs, and community health workers-ASHAs) to increase quantity and quality of home visits for RMNH screenings and services, and media messages to increase demand for services.
| Study group | Role | What they receive |
|---|---|---|
| Ananya Intervention | Experimental | 1. Strengthen enumeration and mapping of areas to ensure reach of front line workers (FLWs: auxiliary nurse midwives- ANMs; community health workers- ASHAs; anganwadi workers- AWWs).
2. Convene monthly FLW meetings to build skills and get trained in job kits to increase the quantity and quality of household visits.
3. Train FLWs on communication skills and use of mobile kunji, a job-aid tool, to improve FLWs' communication with households.
4. A mass media campaign inclusive of street theatre, tv and radio, and a mobile van.
5. Community mobilization linking mass media efforts with self-help groups.
6. Quality improvement activities at public health facilities.
7. Facility-based skills training to staff delivering infants to improve quality of care Receives: Behavioral: Ananya |
| Control Condition | No intervention | standard of care public health services in India |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of two or more home visits from an FLW in the final trimester of pregnancy, using maternal survey response
Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey
Measured: 2 year follow up
Receipt of any postnatal home visits from an FLW (in the first 24 hours at home after delivery and in first month following delivery), using maternal survey response
Assessed via self-report from representative sample of mothers of children aged 0-11 months; items created for Ananya Survey
Measured: 2-year follow-up
Postnatal care behaviors (4 outcomes)- clean cord care, KMC, delayed bath, initiation of breastfeeding), reported by mothers
Postnatal care practices [Nothing applied to cord or umbilicus; Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact; First bath delayed by two or more days; Breastfed child within one hour of birth] assessed via self-report using a single item for each behavior from representative sample of mothers of children aged 0-11 months; items from demographic and health surveys
Measured: 2 year follow-up
Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response
a survey item was used to assesse complementary feeding of infants as reported by mothers of infants aged 0-11 months; items taken from the Demographic and Health Survey
Measured: 2 year follow-up
Immunizations (4 outcomes)- receipt of DBT1 and DBT3 for infants 6-11 mo; receipt of DPT3 and measles vaccine for children 12-23 months, using immunization cards or maternal self report if not card
data from immunization cards or from self-reports when women did not have cards; approximately 50-60% of participants did not have immunization cards
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Maternal and Child HealthStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27,633 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Anita Raj, University of California, San Diego
- Investigators
- Yamini Atmavilas, Principal investigator, Bill and Melinda Gates Foundattion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726230
- Sponsor's protocol ID
- BMGF#22539
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data from this study are public and available from the Bill and Melinda Gates Foundation
Publications
Abdalla S, Pair E, Mehta K, Ward V, Mahapatra T, Darmstadt GL. Improving the precision of maternal, newborn, and child health impact through geospatial analysis of the association of contextual and programmatic factors with health trends in Bihar, India. J Glob Health. 2022 Nov 23;12:04064. doi: 10.7189/jogh.12.04064.
PubMed 36412069Ward V, Abdalla S, Raheel H, Weng Y, Godfrey A, Dutt P, Mitra R, Sastry P, Chamberlain S, Shannon M, Mehta K, Bentley J, Darmstadt Md GL; Ananya Study Group. Implementing health communication tools at scale: mobile audio messaging and paper-based job aids for front-line workers providing community health education to mothers in Bihar, India. BMJ Glob Health. 2021 Jul;6(Suppl 5):e005538. doi: 10.1136/bmjgh-2021-005538.
PubMed 34312155Darmstadt GL, Weng Y, Pepper KT, Ward VC, Mehta KM, Borkum E, Bentley J, Raheel H, Rangarajan A, Bhattacharya D, Tarigopula UK, Nanda P, Sridharan S, Rotz D, Carmichael SL, Abdalla S, Munar W; Ananya Study Group. Impact of the Ananya program on reproductive, maternal, newborn and child health and nutrition in Bihar, India: early results from a quasi-experimental study. J Glob Health. 2020 Dec;10(2):021002. doi: 10.7189/jogh.10.021002. Epub 2020 Dec 19.
PubMed 33427822Abdalla S, Weng Y, Mehta KM, Mahapatra T, Srikantiah S, Shah H, Ward VC, Pepper KT, Bentley J, Carmichael SL, Creanga A, Wilhelm J, Tarigopula UK, Nanda P, Bhattacharya D, Atmavilas Y, Darmstadt GL; Ananya Study Group. Trends in reproductive, maternal, newborn and child health and nutrition indicators during five years of piloting and scaling-up of Ananya interventions in Bihar, India. J Glob Health. 2020 Dec;10(2):021003. doi: 10.7189/jogh.10.021003.
PubMed 33427818Ward VC, Weng Y, Bentley J, Carmichael SL, Mehta KM, Mahmood W, Pepper KT, Abdalla S, Atmavilas Y, Mahapatra T, Srikantiah S, Borkum E, Rangarajan A, Sridharan S, Rotz D, Bhattacharya D, Nanda P, Tarigopula UK, Shah H, Darmstadt GL; Ananya Study Group. Evaluation of a large-scale reproductive, maternal, newborn and child health and nutrition program in Bihar, India, through an equity lens. J Glob Health. 2020 Dec;10(2):021011. doi: 10.7189/jogh.10.021011. Epub 2020 Dec 19.
PubMed 33425335Ghosh R, Spindler H, Dyer J, Christmas A, Cohen SR, Das A, Sonthalia S, Mahapatra T, Gore A, Shah H, Walker DM. Simulation and team training embedded nurse mentoring programme and improvement in intrapartum and newborn care in a low-resource setting in Bihar, India. J Glob Health. 2020 Dec;10(2):021010. doi: 10.7189/jogh.10.021010. Epub 2020 Dec 19.
PubMed 33425334Creanga AA, Jiwani S, Das A, Mahapatra T, Sonthalia S, Gore A, Kaul S, Srikantiah S, Galavotti C, Shah H. Using a mobile nurse mentoring and training program to address a health workforce capacity crisis in Bihar, India: Impact on essential intrapartum and newborn care practices. J Glob Health. 2020 Dec;10(2):021009. doi: 10.7189/jogh.10.021009.
PubMed 33425333Mehta KM, Irani L, Chaudhuri I, Mahapatra T, Schooley J, Srikantiah S, Abdalla S, Ward V, Carmichael SL, Bentley J, Creanga A, Wilhelm J, Tarigopula UK, Bhattacharya D, Atmavilas Y, Nanda P, Weng Y, Pepper KT, Darmstadt GL; Ananya Study Group. Health layering of self-help groups: impacts on reproductive, maternal, newborn and child health and nutrition in Bihar, India. J Glob Health. 2020 Dec;10(2):021007. doi: 10.7189/jogh.10.021007. Epub 2020 Dec 19.
PubMed 33425331Mehta KM, Irani L, Chaudhuri I, Mahapatra T, Schooley J, Srikantiah S, Abdalla S, Ward VC, Carmichael SL, Bentley J, Creanga A, Wilhelm J, Tarigopula UK, Bhattacharya D, Atmavilas Y, Nanda P, Weng Y, Pepper KT, Darmstadt GL; Ananya Study Group. Health impact of self-help groups scaled-up statewide in Bihar, India. J Glob Health. 2020 Dec;10(2):021006. doi: 10.7189/jogh.10.021006. Epub 2020 Dec 19.
PubMed 33425330Ward VC, Raheel H, Weng Y, Mehta KM, Dutt P, Mitra R, Sastry P, Godfrey A, Shannon M, Chamberlain S, Kaimal R, Carmichael SL, Bentley J, Abdalla S, Pepper KT, Mahapatra T, Srikantiah S, Borkum E, Rangarajan A, Sridharan S, Rotz D, Nanda P, Tarigopula UK, Atmavilas Y, Bhattacharya D, Darmstadt GL; Ananya Study Group. Impact of mHealth interventions for reproductive, maternal, newborn and child health and nutrition at scale: BBC Media Action and the Ananya program in Bihar, India. J Glob Health. 2020 Dec;10(2):021005. doi: 10.7189/jogh.10.021005. Epub 2020 Dec 19.
PubMed 33425329Abdalla S, Pair E, Mehta KM, Ward VC, Darmstadt GL. Geospatial variations in trends of reproductive, maternal, newborn and child health and nutrition indicators at block level in Bihar, India, during scale-up of Ananya program interventions. J Glob Health. 2020 Dec;10(2):021004. doi: 10.7189/jogh.10.021004.
PubMed 33425328
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bihar Family Health Initiative (Ananya)
- ClinicalTrials.gov ID
- NCT02726230
- Acronym / sponsor ID
- BMGF#22539
- Conditions
- Maternal and Child Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,633 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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.
Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to increase maternal and neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal districts in western and central Bihar.received Ananya, while 30 districts did not. Data were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess Ananya outcome effects in this quasi experimental study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ananya Intervention | Experimental | Behavioral: Ananya1. Strengthen enumeration and mapping of areas to ensure reach of front line workers (FLWs: auxiliary nurse midwives- ANMs; community health workers- ASHAs; anganwadi workers- AWWs). 2. Convene monthly FLW meetings to build skills and get trained in job kits to increase the quantity and quality of household visits. 3. Train FLWs on communication skills and use of mobile kunji, a job-aid tool, to improve FLWs' communication with households. 4. A mass media campaign inclusive of street theatre, tv and radio, and a mobile van. 5. Community mobilization linking mass media efforts with self-help groups. 6. Quality improvement activities at public health facilities. 7. Facility-based skills training to staff delivering infants to improve quality of care |
| Control Condition | No intervention | –standard of care public health services in India |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers of infants 0-23 months residing in the catchment area of the subcenters (public health facilities) included in this study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AnanyaThe Ananya program was developed and implemented via a partnership of the Bill and Melinda Gates Foundation and the Government of Bihar as a means of improving reproductive, maternal, newborn and child health (RMNCH) outcomes in the state, in particular focusing on improving health behaviors and service utilization in the final trimester of pregnancy and early postpartum period. Ananya was designed as a series of supply- and demand-side efforts to improve health. Efforts were focused on strengthening outreach services in quantity and quality, improving quality of facility services, and mobilizing communities to improve health behaviors. The Ananya program included training, mobilizing, and monitoring of government frontline health workers (FLWs, including anganwadi workers- AWWS, auxiliary nurse midwives- ANMs, and community health workers-ASHAs) to increase quantity and quality of home visits for RMNH screenings and services, and media messages to increase demand for services. | Behavioural | Ananya Intervention |
Primary outcome
Receipt of two or more home visits from an FLW in the final trimester of pregnancy, using maternal survey response
Time frame: 2 year follow up
Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey
Receipt of any postnatal home visits from an FLW (in the first 24 hours at home after delivery and in first month following delivery), using maternal survey response
Time frame: 2-year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months; items created for Ananya Survey
Postnatal care behaviors (4 outcomes)- clean cord care, KMC, delayed bath, initiation of breastfeeding), reported by mothers
Time frame: 2 year follow-up
Postnatal care practices [Nothing applied to cord or umbilicus; Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact; First bath delayed by two or more days; Breastfed child within one hour of birth] assessed via self-report using a single item for each behavior from representative sample of mothers of children aged 0-11 months; items from demographic and health surveys
Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response
Time frame: 2 year follow-up
a survey item was used to assesse complementary feeding of infants as reported by mothers of infants aged 0-11 months; items taken from the Demographic and Health Survey
Immunizations (4 outcomes)- receipt of DBT1 and DBT3 for infants 6-11 mo; receipt of DPT3 and measles vaccine for children 12-23 months, using immunization cards or maternal self report if not card
Time frame: 2 year follow-up
data from immunization cards or from self-reports when women did not have cards; approximately 50-60% of participants did not have immunization cards
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Derived from this study: PubMed 36412069Abdalla S, Pair E, Mehta K, Ward V, Mahapatra T, Darmstadt GL. Improving the precision of maternal, newborn, and child health impact through geospatial analysis of the association of contextual and programmatic factors with health trends in Bihar, India. J Glob Health. 2022 Nov 23;12:04064. doi: 10.7189/jogh.12.04064.
- Derived from this study: PubMed 34312155Ward V, Abdalla S, Raheel H, Weng Y, Godfrey A, Dutt P, Mitra R, Sastry P, Chamberlain S, Shannon M, Mehta K, Bentley J, Darmstadt Md GL; Ananya Study Group. Implementing health communication tools at scale: mobile audio messaging and paper-based job aids for front-line workers providing community health education to mothers in Bihar, India. BMJ Glob Health. 2021 Jul;6(Suppl 5):e005538. doi: 10.1136/bmjgh-2021-005538.
- Derived from this study: PubMed 33427822Darmstadt GL, Weng Y, Pepper KT, Ward VC, Mehta KM, Borkum E, Bentley J, Raheel H, Rangarajan A, Bhattacharya D, Tarigopula UK, Nanda P, Sridharan S, Rotz D, Carmichael SL, Abdalla S, Munar W; Ananya Study Group. Impact of the Ananya program on reproductive, maternal, newborn and child health and nutrition in Bihar, India: early results from a quasi-experimental study. J Glob Health. 2020 Dec;10(2):021002. doi: 10.7189/jogh.10.021002. Epub 2020 Dec 19.
- Derived from this study: PubMed 33427818Abdalla S, Weng Y, Mehta KM, Mahapatra T, Srikantiah S, Shah H, Ward VC, Pepper KT, Bentley J, Carmichael SL, Creanga A, Wilhelm J, Tarigopula UK, Nanda P, Bhattacharya D, Atmavilas Y, Darmstadt GL; Ananya Study Group. Trends in reproductive, maternal, newborn and child health and nutrition indicators during five years of piloting and scaling-up of Ananya interventions in Bihar, India. J Glob Health. 2020 Dec;10(2):021003. doi: 10.7189/jogh.10.021003.
- Derived from this study: PubMed 33425335Ward VC, Weng Y, Bentley J, Carmichael SL, Mehta KM, Mahmood W, Pepper KT, Abdalla S, Atmavilas Y, Mahapatra T, Srikantiah S, Borkum E, Rangarajan A, Sridharan S, Rotz D, Bhattacharya D, Nanda P, Tarigopula UK, Shah H, Darmstadt GL; Ananya Study Group. Evaluation of a large-scale reproductive, maternal, newborn and child health and nutrition program in Bihar, India, through an equity lens. J Glob Health. 2020 Dec;10(2):021011. doi: 10.7189/jogh.10.021011. Epub 2020 Dec 19.
- Derived from this study: PubMed 33425334Ghosh R, Spindler H, Dyer J, Christmas A, Cohen SR, Das A, Sonthalia S, Mahapatra T, Gore A, Shah H, Walker DM. Simulation and team training embedded nurse mentoring programme and improvement in intrapartum and newborn care in a low-resource setting in Bihar, India. J Glob Health. 2020 Dec;10(2):021010. doi: 10.7189/jogh.10.021010. Epub 2020 Dec 19.
- Derived from this study: PubMed 33425333Creanga AA, Jiwani S, Das A, Mahapatra T, Sonthalia S, Gore A, Kaul S, Srikantiah S, Galavotti C, Shah H. Using a mobile nurse mentoring and training program to address a health workforce capacity crisis in Bihar, India: Impact on essential intrapartum and newborn care practices. J Glob Health. 2020 Dec;10(2):021009. doi: 10.7189/jogh.10.021009.
- Derived from this study: PubMed 33425331Mehta KM, Irani L, Chaudhuri I, Mahapatra T, Schooley J, Srikantiah S, Abdalla S, Ward V, Carmichael SL, Bentley J, Creanga A, Wilhelm J, Tarigopula UK, Bhattacharya D, Atmavilas Y, Nanda P, Weng Y, Pepper KT, Darmstadt GL; Ananya Study Group. Health layering of self-help groups: impacts on reproductive, maternal, newborn and child health and nutrition in Bihar, India. J Glob Health. 2020 Dec;10(2):021007. doi: 10.7189/jogh.10.021007. Epub 2020 Dec 19.
- Derived from this study: PubMed 33425330Mehta KM, Irani L, Chaudhuri I, Mahapatra T, Schooley J, Srikantiah S, Abdalla S, Ward VC, Carmichael SL, Bentley J, Creanga A, Wilhelm J, Tarigopula UK, Bhattacharya D, Atmavilas Y, Nanda P, Weng Y, Pepper KT, Darmstadt GL; Ananya Study Group. Health impact of self-help groups scaled-up statewide in Bihar, India. J Glob Health. 2020 Dec;10(2):021006. doi: 10.7189/jogh.10.021006. Epub 2020 Dec 19.
- Derived from this study: PubMed 33425329Ward VC, Raheel H, Weng Y, Mehta KM, Dutt P, Mitra R, Sastry P, Godfrey A, Shannon M, Chamberlain S, Kaimal R, Carmichael SL, Bentley J, Abdalla S, Pepper KT, Mahapatra T, Srikantiah S, Borkum E, Rangarajan A, Sridharan S, Rotz D, Nanda P, Tarigopula UK, Atmavilas Y, Bhattacharya D, Darmstadt GL; Ananya Study Group. Impact of mHealth interventions for reproductive, maternal, newborn and child health and nutrition at scale: BBC Media Action and the Ananya program in Bihar, India. J Glob Health. 2020 Dec;10(2):021005. doi: 10.7189/jogh.10.021005. Epub 2020 Dec 19.
- Derived from this study: PubMed 33425328Abdalla S, Pair E, Mehta KM, Ward VC, Darmstadt GL. Geospatial variations in trends of reproductive, maternal, newborn and child health and nutrition indicators at block level in Bihar, India, during scale-up of Ananya program interventions. J Glob Health. 2020 Dec;10(2):021004. doi: 10.7189/jogh.10.021004.
- Individual participant dataSharing planned: Yes. Data from this study are public and available from the Bill and Melinda Gates Foundation
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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.
Yamini Atmavilas principal investigator
Bill and Melinda Gates Foundattion
Questions about this trial
What is this clinical trial studying?
A study testing Ananya in people with Maternal and Child Health, run by University of California, San Diego.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 1 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of two or more home visits from an FLW in the final trimester of pregnancy, using maternal survey response (time frame: 2 year follow up). The study lists 5 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 NCT02726230, which also lists 11 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 Apr 2016.