Gestational Diabetes Mellitus (GDM)NCT03700034
mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal
A study testing mHealth Integrated Model of Antenatal Care in people with Gestational Diabetes Mellitus (GDM) and Pregnancy Induced Hypertension (PIH), run by Public Health Foundation of India at 6 sites in 2 countries.
Trial summary
Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Pregnancy Induced Hypertension (PIH), Anemia
- What is being tested?
- mHealth Integrated Model of Antenatal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 10 Jul 2024to 1 Sep 2026
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women visiting a trial facility up to the end of the 28th week of gestation
- Women who are planning to remain within the five study districts until at least one-month post-partum OR women whose mothers reside in the selected districts
Who cannot join
- Women coming to the trial facility for a non-routine ANC visit (for example, to get a laboratory investigation, to collect a report or her medicine)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
India5 sites
Primary Health Centres (PHCs)
Medak, Telangana
Primary Health Centres (PHCs)
Rangareddy, Telangana
Primary Health Centres
Siddipet, Telangana
Primary Health Centres (PHCs)
Vikārābād, Telangana
Primary Health Centres (PHCs)
Yadadri Bhuvnagiri, Telangana
About this study
Official title: A Cluster-randomized Trial of an mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in Primary Care Settings in India and Nepal
Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). This intervention -"mIRA" - is an mHealth integrated model of hypertension, diabetes, and antenatal care in primary care settings. mIRA aims to (a) prompt frontline health workers (FHWs) to provide evidence-based routine ANC, and also enhance the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia, whilst improving adherence to National ANC guidelines; (b) facilitate record-keeping and reporting and; (c) link providers across various levels of care to improve continuity of care.
A cluster randomized controlled (cRCT) to assess the effectiveness of the mIRA EDSS in improving ANC and enhancing the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia will be conducted in Telangana, India. A mixed-methods process evaluation will be conducted in both India and Nepal. The process evaluation will contribute to our understanding of the mechanisms contributing to changes (improvement) in the quality of ANC by using the EDSS intervention.
Read the detailed description
The cRCT aims to evaluate the effectiveness of a tablet-based EDSS in improving the quality of ANC and enhancing the detection and management of PIH, GDM, and anemia at primary care level health facilities in five districts of Telangana State: Medak, Rangareddy, Siddipet, Vikarabad, and Yadadri Bhuvangiri. The EDSS will use evidence-based algorithms to suggest recommendations to the FHWs for providing ANC, based on the pregnant woman's history, examination, and investigations, as well as incorporate reminders to ensure all relevant components of ANC are recorded. The aim is to ensure that ANC components received during multiple visits from multiple healthcare providers are captured and contribute to coordinated care. FHWs, primarily Auxiliary Nurse Midwives (ANMs), will use the EDSS during ANC consultations with pregnant women at Sub-Centres, while at the Primary Health Centres (PHCs), this will be used by Medical Officers (MOs) and staff nurses.
In these selected districts, which are predominantly rural, 66 clusters with each cluster comprising a PHC and its two reporting Sub-Centres, will be randomized with a 1:1 allocation ratio to the intervention arm (providing ANC using the mIRA EDSS intervention) and the control arm (providing usual care), using a computer-generated randomization schedule stratified by the district. Covariate constrained randomization will be used to balance the arms on the following baseline covariates: the presence of a laboratory and laboratory technician (yes/no); more than three staff providing ANC (yes/no); facility type (PHCs that are open 24/7 or those not open 24/7).
The cRCT will not be conducted In Nepal, however, the mIRA EDSS will be implemented at government Health Posts (HP), government Primary Health Care Centers (PHCCs), and Dhulikhel Hospital Outreach Centers (DHORCs), in four catchment districts (Kavrepalanchok, Sindhupalchowk, Sindhuli, and Dolakha) of Dhulikhel Hospital. A pre-post EDSS implementation outcome evaluation will be conducted. The process evaluation research activities conducted in India and Nepal will be the same (including a baseline facility survey, routine monitoring, and audit of record-keeping), except for a longitudinal case study and a time-motion study that will be conducted only in Nepal. Additionally, endline qualitative in-depth interviews with healthcare providers, facility managers, district and state health officials and policymakers, and with members of the Public Health Foundation of India team (intervention implementors) will be conducted only in India.
- Being tested
- mHealth Integrated Model of Antenatal Care
- Keywords
- Antenatal care, Pregnancy care, Pregnancy complications, Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Anemia
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Anemia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Integrated Model of Antenatal CareOther
Also called Electronic Decision Based System (EDSS)
In the intervention facilities, antenatal care (ANC) will be provided to all pregnant women using the mIRA electronic decision support system (EDSS) by ANMs (Auxiliary Nurse Midwife), Staff nurses, or Medical Officers (MOs). These frontline healthcare workers (FHWs) will be trained to use the EDSS and will also be provided "refresher" training on the guideline-recommended processes of ANC. This training will enable them to use the mIRA EDSS in the provision of ANC. Non-physician FHWs (ANMs and staff nurses) will screen, detect, and refer PIH, GDM, and severe anemia cases. They will not prescribe treatments, but will carry out all other duties including diagnosis, referral to the MO to prescribe drugs, provide lifestyle advice, follow-up, and subsequently support adherence to management plans.
| Study group | Role | What they receive |
|---|---|---|
| mHealth integrated model of hypertension, diabetes, anemia, and antenatal care | Experimental | The mIRA trial intervention will consist of an electronic decision support system (EDSS), provided to healthcare providers at primary-level facilities in India and Nepal to deliver enhanced ANC with improved detection and management of pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM) and anemia. Receives: Other: mHealth Integrated Model of Antenatal Care |
| Routine antenatal care | No intervention | In the control clusters, pregnant women will receive the existing standard of care (usual care) from Frontline Health Workers (FHWs). Evidence-based guidelines in the form of posters/pamphlets on current national and state guidelines on screening and management of pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), anemia, and routine ANC procedures will be provided to all the control health facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of four selected ANC components delivered by the healthcare providers per visit, observed over two visits- the trial enrolment visit and the next routine ANC appointment.
This will be a composite score calculated as per the performance of the number of selected ANC components delivered or completed by the healthcare provider. The four selected components are: 1) the measurement and recording of systolic and diastolic blood pressure; 2) measurement of blood glucose, 3) performing urinary dipstick test for proteinuria and 4) conducting hemoglobin tests. The action of completing each of the aforementioned components by the healthcare provider will count as a score of one. Thus, completion of all four components will account to a score of four.
Measured: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Secondary outcomes (7)
Mean number of the four selected ANC components delivered by the healthcare provider observed at the trial enrolment visit
This will be a composite score calculated as per the performance of the number of selected ANC components delivered or completed by the healthcare provider. The four selected components are: 1) the measurement and recording of systolic and diastolic blood pressure; 2) measurement of blood glucose, 3) performing urinary dipstick test for proteinuria and 4) conducting hemoglobin tests. The action of completing each of the aforementioned components by the healthcare provider will count as a score of one. Thus, completion of all four components will account to a score of four.
Measured: Up to 28 weeks of gestation
Mean number of the current pregnancy symptoms discussed with participants (either by the provider asking or the woman mentioning), observed over the two visits.
Symptoms include: nausea, vomiting, vaginal bleeding, severe headache, decreased or absent fetal movement, severe abdominal pain, blurred vision
Measured: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Proportion of providers who took the appropriate action (as defined by the EDSS) in response to aforementioned current pregnancy symptoms or who were told that they had hypertension in pregnancy, GDM or anemia
Symptoms for which a response is expected from the provider: vomiting, vaginal bleeding, severe headache, decreased or absent foetal movement, severe abdominal pain or blurred vision or who were told that they had hypertension in pregnancy, GDM or anemia
Measured: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Mean number of the danger signs mentioned to each participant by the healthcare provider for which she is advised to return for help
Danger signs include severe vomiting, vaginal bleeding, severe headache, decreased or no foetal movement, severe abdominal pain, blurred vision
Measured: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Proportion of participants with clinical parameters indicative of PIH, GDM or severe anemia
Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting >92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) >180 mg/dL, 2 h OGTT >153-199 mg/dL; glucometer test values: fasting >92 mg/dL, 1 h OGTT >198 mg/dL, 2 h OGTT >168 mg/dL) or severe anemia (<7g/dL)
Measured: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Proportion of participants who were told by the provider that they had PIH, GDM or severe anemia
Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting >92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) >180 mg/dL, 2 h OGTT >153-199 mg/dL; glucometer test values: fasting >92 mg/dL, 1 h OGTT >198 mg/dL, 2 h OGTT >168 mg/dL) or severe anemia (<7g/dL)
Measured: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Mean number of quality antenatal care components delivered in the enrolment visit
The components are as follows:
tests completed: blood pressure; blood glucose; urinary dipstick; hemoglobin tests
Provider:
symptom check: nausea; vomiting; vaginal bleeding; severe headache, decreased or absent foetal movement, severe abdominal pain, blurred vision
warning about: severe vomiting; vaginal bleeding; severe headache; decreased or no foetal movement: severe abdominal pain; blurred vision
counseling on diet
enquiring about mental health
recording ANC related information on the women-held MCP (Maternal and Chlid Protection) card
Measured: Up to 28 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Jul 2024
- Primary completion10 Dec 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of India
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kathmandu University School of Medical Sciences, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Dorairaj Prabhakaran, Public Health Foundation of India
- Investigators
- Dorairaj Prabhakaran, DM, Principal investigator, Vice President, Research and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700034
- Sponsor's protocol ID
- CTRI/2019/01/016857
- Status last verified
- May 2026
- First submitted
- 4 Oct 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohan S, Chaudhry M, McCarthy O, Jarhyan P, Calvert C, Jindal D, Shakya R, Radovich E, Kondal D, Penn-Kekana L, Basany K, Roy A, Tandon N, Shrestha A, Shrestha A, Karmacharya B, Cairns J, Perel P, Campbell OMR, Prabhakaran D. A cluster randomized controlled trial of an electronic decision-support system to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: trial protocol. BMC Pregnancy Childbirth. 2023 Jan 26;23(1):72. doi: 10.1186/s12884-022-05249-y.
PubMed 36703109
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Trial of an mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in Primary Care Settings in India and Nepal
- ClinicalTrials.gov ID
- NCT03700034
- Acronym / sponsor ID
- CTRI/2019/01/016857
- Keywords
- Antenatal care, Pregnancy care, Pregnancy complications, Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Anemia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Public Health Foundation of IndiaUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kathmandu University School of Medical Sciences, Bill and Melinda Gates Foundation
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Oct 2018 (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.
Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). This intervention -"mIRA" - is an mHealth integrated model of hypertension, diabetes, and antenatal care in primary care settings. mIRA aims to (a) prompt frontline health workers (FHWs) to provide evidence-based routine ANC, and also enhance the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia, whilst improving adherence to National ANC guidelines; (b) facilitate record-keeping and reporting and; (c) link providers across various levels of care to improve continuity of care.
A cluster randomized controlled (cRCT) to assess the effectiveness of the mIRA EDSS in improving ANC and enhancing the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia will be conducted in Telangana, India. A mixed-methods process evaluation will be conducted in both India and Nepal. The process evaluation will contribute to our understanding of the mechanisms contributing to changes (improvement) in the quality of ANC by using the EDSS intervention.
Detailed description
The cRCT aims to evaluate the effectiveness of a tablet-based EDSS in improving the quality of ANC and enhancing the detection and management of PIH, GDM, and anemia at primary care level health facilities in five districts of Telangana State: Medak, Rangareddy, Siddipet, Vikarabad, and Yadadri Bhuvangiri. The EDSS will use evidence-based algorithms to suggest recommendations to the FHWs for providing ANC, based on the pregnant woman's history, examination, and investigations, as well as incorporate reminders to ensure all relevant components of ANC are recorded. The aim is to ensure that ANC components received during multiple visits from multiple healthcare providers are captured and contribute to coordinated care. FHWs, primarily Auxiliary Nurse Midwives (ANMs), will use the EDSS during ANC consultations with pregnant women at Sub-Centres, while at the Primary Health Centres (PHCs), this will be used by Medical Officers (MOs) and staff nurses.
In these selected districts, which are predominantly rural, 66 clusters with each cluster comprising a PHC and its two reporting Sub-Centres, will be randomized with a 1:1 allocation ratio to the intervention arm (providing ANC using the mIRA EDSS intervention) and the control arm (providing usual care), using a computer-generated randomization schedule stratified by the district. Covariate constrained randomization will be used to balance the arms on the following baseline covariates: the presence of a laboratory and laboratory technician (yes/no); more than three staff providing ANC (yes/no); facility type (PHCs that are open 24/7 or those not open 24/7).
The cRCT will not be conducted In Nepal, however, the mIRA EDSS will be implemented at government Health Posts (HP), government Primary Health Care Centers (PHCCs), and Dhulikhel Hospital Outreach Centers (DHORCs), in four catchment districts (Kavrepalanchok, Sindhupalchowk, Sindhuli, and Dolakha) of Dhulikhel Hospital. A pre-post EDSS implementation outcome evaluation will be conducted. The process evaluation research activities conducted in India and Nepal will be the same (including a baseline facility survey, routine monitoring, and audit of record-keeping), except for a longitudinal case study and a time-motion study that will be conducted only in Nepal. Additionally, endline qualitative in-depth interviews with healthcare providers, facility managers, district and state health officials and policymakers, and with members of the Public Health Foundation of India team (intervention implementors) will be conducted only in India.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth integrated model of hypertension, diabetes, anemia, and antenatal care | Experimental | Other: mHealth Integrated Model of Antenatal CareThe mIRA trial intervention will consist of an electronic decision support system (EDSS), provided to healthcare providers at primary-level facilities in India and Nepal to deliver enhanced ANC with improved detection and management of pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM) and anemia. |
| Routine antenatal care | No intervention | –In the control clusters, pregnant women will receive the existing standard of care (usual care) from Frontline Health Workers (FHWs). Evidence-based guidelines in the form of posters/pamphlets on current national and state guidelines on screening and management of pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), anemia, and routine ANC procedures will be provided to all the control health facilities. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women visiting a trial facility up to the end of the 28th week of gestation
- Women who are planning to remain within the five study districts until at least one-month post-partum OR women whose mothers reside in the selected districts
Key exclusion criteria (1 listed)
- Women coming to the trial facility for a non-routine ANC visit (for example, to get a laboratory investigation, to collect a report or her medicine)
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 |
|---|---|---|
| mHealth Integrated Model of Antenatal CareAlso: Electronic Decision Based System (EDSS)In the intervention facilities, antenatal care (ANC) will be provided to all pregnant women using the mIRA electronic decision support system (EDSS) by ANMs (Auxiliary Nurse Midwife), Staff nurses, or Medical Officers (MOs). These frontline healthcare workers (FHWs) will be trained to use the EDSS and will also be provided "refresher" training on the guideline-recommended processes of ANC. This training will enable them to use the mIRA EDSS in the provision of ANC. Non-physician FHWs (ANMs and staff nurses) will screen, detect, and refer PIH, GDM, and severe anemia cases. They will not prescribe treatments, but will carry out all other duties including diagnosis, referral to the MO to prescribe drugs, provide lifestyle advice, follow-up, and subsequently support adherence to management plans. | Other | mHealth integrated model of hypertension, diabetes, anemia, and antenatal care |
Primary outcome
Mean number of four selected ANC components delivered by the healthcare providers per visit, observed over two visits- the trial enrolment visit and the next routine ANC appointment.
Time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
This will be a composite score calculated as per the performance of the number of selected ANC components delivered or completed by the healthcare provider. The four selected components are: 1) the measurement and recording of systolic and diastolic blood pressure; 2) measurement of blood glucose, 3) performing urinary dipstick test for proteinuria and 4) conducting hemoglobin tests. The action of completing each of the aforementioned components by the healthcare provider will count as a score of one. Thus, completion of all four components will account to a score of four.
7 secondary outcomes
Mean number of the four selected ANC components delivered by the healthcare provider observed at the trial enrolment visit
Time frame: Up to 28 weeks of gestation
Mean number of the current pregnancy symptoms discussed with participants (either by the provider asking or the woman mentioning), observed over the two visits.
Time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Proportion of providers who took the appropriate action (as defined by the EDSS) in response to aforementioned current pregnancy symptoms or who were told that they had hypertension in pregnancy, GDM or anemia
Time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Mean number of the danger signs mentioned to each participant by the healthcare provider for which she is advised to return for help
Time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Proportion of participants with clinical parameters indicative of PIH, GDM or severe anemia
Time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Proportion of participants who were told by the provider that they had PIH, GDM or severe anemia
Time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Mean number of quality antenatal care components delivered in the enrolment visit
Time frame: Up to 28 weeks of gestation
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 14 May 2026.
- Derived from this study: PubMed 36703109Mohan S, Chaudhry M, McCarthy O, Jarhyan P, Calvert C, Jindal D, Shakya R, Radovich E, Kondal D, Penn-Kekana L, Basany K, Roy A, Tandon N, Shrestha A, Shrestha A, Karmacharya B, Cairns J, Perel P, Campbell OMR, Prabhakaran D. A cluster randomized controlled trial of an electronic decision-support system to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: trial protocol. BMC Pregnancy Childbirth. 2023 Jan 26;23(1):72. doi: 10.1186/s12884-022-05249-y.
- Individual participant dataSharing planned: No
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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.
Dorairaj Prabhakaran, DM principal investigator
Vice President, Research and Policy
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Integrated Model of Antenatal Care in people with Gestational Diabetes Mellitus (GDM) and Pregnancy Induced Hypertension (PIH), run by Public Health Foundation of India at 6 sites in 2 countries.
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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India, 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?
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?
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?
Mean number of four selected ANC components delivered by the healthcare providers per visit, observed over two visits- the trial enrolment visit and the next routine ANC appointment. (time frame: Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months). 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 NCT03700034, which also lists 1 linked publication.
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 14 May 2026.