Anemia of PregnancyNCT05752955
SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth
A study testing SMARThealth Pregnancy in people with Anemia of Pregnancy and Gestational Diabetes, run by The George Institute at 1 site in India.
Trial summary
The goal of this clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anemia of Pregnancy, Gestational Diabetes, Gestational Hypertension
- What is being tested?
- SMARThealth Pregnancy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,446 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jun 2022to 1 May 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Primary health Centres:
- located in the selected districts
- provide pregnancy care
- chief doctor (or equivalent) agrees to participate
- For women >12 weeks pregnant
Who cannot join
- women who plan to move away and not return to the same village for the next 12 months
- women unable to understand the local study language
- Women who do not give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster-randomised Trial of a Complex Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth in Women Living in Rural India (SMART Health Pregnancy 2)
The goal of this clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India.
The main questions it aims to answer are:
- Can screening of pregnant and postpartum women using the SMARThealth Pregnancy intervention decrease anaemia prevalence at 1 year after birth?
- Can the SMARThealth Pregnancy intervention improve postnatal testing after a pregnancy affected by hypertension and diabetes? Participants in the intervention group will be screened by their community health worker at several timepoints during pregnancy, and in the first year after birth using the SMARThealth Pregnancy tablet App. The community health worker will ask about each woman about her medical and obstetric history, then measure her blood pressure, haemoglobin (using a point of care device), and offer a referral for a glucose tolerance test when indicated. Women who screen positive for anaemia, hypertension or diabetes will be given advice and referred to the primary care doctor. The primary care doctor will have a complimentary tablet app to facilitate electronic referral and evidence-based prescribing when indicated. The comparison group will have usual antenatal and postnatal care.
Read the detailed description
The primary aim of this study is to determine if the SMARThealth Pregnancy intervention can improve women's health in the year after pregnancy, specifically decrease the prevalence of anaemia by 9% and improve follow-up after a pregnancy affected by diabetes or hypertension. High glucose and blood pressure are the two leading contributors to cardiometabolic risk in women in India, thus it is hypothesised that targeting women identified in pregnancy at high risk of these conditions future risk can be decreased.
This study hypothesize SMARThealth Pregnancy intervention will:
- Decrease anaemia prevalence by 9% in women at 12 months after delivery by improving adherence to the current national government guidelines for iron folic acid supplementation through behavioural change interventions delivered to the woman by the Community Health Worker (CHW): (i) during pregnancy, with referral for iron sucrose injections where indicated; and, (ii) during breastfeeding, and (iii) after breastfeeding.
- Ensure women who develop gestational diabetes mellitus (GDM) are identified during pregnancy with appropriate referral, and followed up after birth and screened for the development of type 2 diabetes.
- Detect women with raised blood pressure during pregnancy, and provide ongoing periodic blood pressure (BP) monitoring after birth to detect ongoing hypertension.
- Provide all women during pregnancy and after birth regular mental health assessment and support leading to improved mental state and wellbeing
- Ensure after birth women are offered and have access to appropriate contraception choices
- Improve communication between different levels of the health system (community, subcenter, Primary health Centre (PHC) and district hospital)
Recruitment commenced in Siddipet district 6 June 2022 and will commence in Haryana 1 January 2023.
- Conditions
- Anemia of Pregnancy, Gestational Diabetes, Gestational Hypertension, Pre-Eclampsia, Anemia, Type 2 Diabetes
- Being tested
- SMARThealth Pregnancy
- Keywords
- Community Health Workers, mobile Health, Accredited Social Health Activist, Health Systems, Cardiometabolic diseases, Screening
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Anemia, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARThealth PregnancyOther
At each visit, the CHW will:
- Update history and contact details
- Check haemoglobin with a point of care device.
- Check BP
- Check iron folic acid (IFA) supply and compliance
- Brief screen for mental health problems
An electronic decision support platform will provide advice if referral is needed. At the Primary Health Centre, doctor/s will be issued a tablet computer with a version of the SMARThealth Pregnancy App to:
- Generate an automated list of all patients in the community who require review, with the dates of testing and referral, and with two-way communication back to the CHW.
- Suggest management based on current Indian guidelines for the diagnosis and management of anaemia, hypertension and diabetes in pregnant and non-pregnant adults.
| Study group | Role | What they receive |
|---|---|---|
| SMARThealth Pregnancy | Experimental | SMART Health Pregnancy is a complex intervention designed to be delivered on top of usual care. It comprises three parts:
(i) A regular screening program focused on women's health during pregnancy and in the year following birth.
(ii) An electronic decision support system (EDSS) (iii) An short messaging service (SMS) appointment reminder system Receives: Other: SMARThealth Pregnancy |
| Active Comparator: Usual Care | No intervention | Usual antenatal and postnatal care. Women and health workers in the usual care clusters will not receive any additional support beyond that already offered under the local government programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change anaemia prevalence in women
Proportion of participants with any degree of anaemia (non-pregnant definition Hb < 12g/dL) between the intervention and control clusters
Measured: 10-12 months after delivery
Secondary outcomes (9)
Change the proportion of women with moderate and severe anaemia
Proportion of participants with moderate anaemia (Hb < 10g /dL) and severe anaemia (Hb < 8g /dL) between the intervention and control clusters
Measured: 10-12 months after delivery
Postnatal screening for type 2 diabetes after GDM
Proportion of women with GDM who undergo screening for type 2 diabetes in the first year after delivery
Measured: 10-12 months after delivery
Postnatal screening for hypertension after hypertensive disorder of pregnancy
Proportion of women with a hypertensive disorder of pregnancy screened for hypertension in the first year after delivery
Measured: 10-12 months after delivery
Compliance with iron-folic acid supplements during pregnancy and breastfeeding
Self reported compliance with iron folic acid supplementation
Measured: 10-12 months after delivery
De-worming treatment
Proportion of women during pregnancy who receive de-worming treatment
Measured: during pregnancy
Point of care Haemoglobin (Hb) testing
Proportion of women who have a point of care Hb test during pregnancy and in the post natal period
Measured: 10-12 months after delivery
Referral of high risk conditions
The proportion of women detected with anaemia, hypertension or GDM correctly referred to primary or secondary care
Measured: Six weeks post delivery
Hypertension after hypertensive disorder of pregnancy
Differences in systolic and diastolic blood pressure in women who were diagnosed during pregnancy with hypertensive disorder of pregnancy
Measured: 10-12 months after delivery
Dysglycaemia after a pregnancy affected by GDM
Difference in HbA1c, fasting and 2-hour glucose venous samples post 75 gram glucose load in those who developed GDM during pregnancy
Measured: 10-12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start6 Jun 2022
- Primary completion31 Dec 2024
- Study completion1 May 2025
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 Anemia of PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Jane E Hirst, MBBS MPH PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752955
- Sponsor's protocol ID
- 27-21
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual data and data dictionary will be made available for sharing on the day of publication of the main results. Data will be made available through a 3rd party data repository, via email request to the Principal Investigator on receipt of a signed data sharing agreement.
Publications
Nagraj S, Kennedy SH, Jha V, Norton R, Hinton L, Billot L, Rajan E, Arora V, Praveen D, Hirst JE. SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial. Front Glob Womens Health. 2021 May 28;2:620759. doi: 10.3389/fgwh.2021.620759. eCollection 2021.
PubMed 34816187Hirst JE, Votruba N, Billot L, Arora V, Rajan E, Thout SR, Peiris D, Patel A, Norton R, Mullins E, Sharma A, Kennedy S, Jha V, Praveen D. A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial. Trials. 2023 Aug 9;24(1):510. doi: 10.1186/s13063-023-07510-x.
PubMed 37559158
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomised Trial of a Complex Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth in Women Living in Rural India (SMART Health Pregnancy 2)
- ClinicalTrials.gov ID
- NCT05752955
- Acronym / sponsor ID
- 27-21
- Conditions
- Anemia of Pregnancy, Gestational Diabetes, Gestational Hypertension, Pre-Eclampsia, Anemia, Type 2 Diabetes
- Keywords
- Community Health Workers, mobile Health, Accredited Social Health Activist, Health Systems, Cardiometabolic diseases, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,446 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 3 Mar 2023 (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 clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India.
The main questions it aims to answer are:
- Can screening of pregnant and postpartum women using the SMARThealth Pregnancy intervention decrease anaemia prevalence at 1 year after birth?
- Can the SMARThealth Pregnancy intervention improve postnatal testing after a pregnancy affected by hypertension and diabetes? Participants in the intervention group will be screened by their community health worker at several timepoints during pregnancy, and in the first year after birth using the SMARThealth Pregnancy tablet App. The community health worker will ask about each woman about her medical and obstetric history, then measure her blood pressure, haemoglobin (using a point of care device), and offer a referral for a glucose tolerance test when indicated. Women who screen positive for anaemia, hypertension or diabetes will be given advice and referred to the primary care doctor. The primary care doctor will have a complimentary tablet app to facilitate electronic referral and evidence-based prescribing when indicated. The comparison group will have usual antenatal and postnatal care.
Detailed description
The primary aim of this study is to determine if the SMARThealth Pregnancy intervention can improve women's health in the year after pregnancy, specifically decrease the prevalence of anaemia by 9% and improve follow-up after a pregnancy affected by diabetes or hypertension. High glucose and blood pressure are the two leading contributors to cardiometabolic risk in women in India, thus it is hypothesised that targeting women identified in pregnancy at high risk of these conditions future risk can be decreased.
This study hypothesize SMARThealth Pregnancy intervention will:
- Decrease anaemia prevalence by 9% in women at 12 months after delivery by improving adherence to the current national government guidelines for iron folic acid supplementation through behavioural change interventions delivered to the woman by the Community Health Worker (CHW): (i) during pregnancy, with referral for iron sucrose injections where indicated; and, (ii) during breastfeeding, and (iii) after breastfeeding.
- Ensure women who develop gestational diabetes mellitus (GDM) are identified during pregnancy with appropriate referral, and followed up after birth and screened for the development of type 2 diabetes.
- Detect women with raised blood pressure during pregnancy, and provide ongoing periodic blood pressure (BP) monitoring after birth to detect ongoing hypertension.
- Provide all women during pregnancy and after birth regular mental health assessment and support leading to improved mental state and wellbeing
- Ensure after birth women are offered and have access to appropriate contraception choices
- Improve communication between different levels of the health system (community, subcenter, Primary health Centre (PHC) and district hospital)
Recruitment commenced in Siddipet district 6 June 2022 and will commence in Haryana 1 January 2023.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| SMARThealth Pregnancy | Experimental | Other: SMARThealth PregnancySMART Health Pregnancy is a complex intervention designed to be delivered on top of usual care. It comprises three parts: (i) A regular screening program focused on women's health during pregnancy and in the year following birth. (ii) An electronic decision support system (EDSS) (iii) An short messaging service (SMS) appointment reminder system |
| Active Comparator: Usual Care | No intervention | –Usual antenatal and postnatal care. Women and health workers in the usual care clusters will not receive any additional support beyond that already offered under the local government programs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For Primary health Centres:
- For women >12 weeks pregnant
Key exclusion criteria (3 listed)
- women who plan to move away and not return to the same village for the next 12 months
- women unable to understand the local study language
- Women who do not give consent
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 |
|---|---|---|
| SMARThealth PregnancyAt each visit, the CHW will: * Update history and contact details * Check haemoglobin with a point of care device. * Check BP * Check iron folic acid (IFA) supply and compliance * Brief screen for mental health problems An electronic decision support platform will provide advice if referral is needed. At the Primary Health Centre, doctor/s will be issued a tablet computer with a version of the SMARThealth Pregnancy App to: * Generate an automated list of all patients in the community who require review, with the dates of testing and referral, and with two-way communication back to the CHW. * Suggest management based on current Indian guidelines for the diagnosis and management of anaemia, hypertension and diabetes in pregnant and non-pregnant adults. | Other | SMARThealth Pregnancy |
Primary outcome
Change anaemia prevalence in women
Time frame: 10-12 months after delivery
Proportion of participants with any degree of anaemia (non-pregnant definition Hb < 12g/dL) between the intervention and control clusters
9 secondary outcomes
Change the proportion of women with moderate and severe anaemia
Time frame: 10-12 months after delivery
Postnatal screening for type 2 diabetes after GDM
Time frame: 10-12 months after delivery
Postnatal screening for hypertension after hypertensive disorder of pregnancy
Time frame: 10-12 months after delivery
Compliance with iron-folic acid supplements during pregnancy and breastfeeding
Time frame: 10-12 months after delivery
De-worming treatment
Time frame: during pregnancy
Point of care Haemoglobin (Hb) testing
Time frame: 10-12 months after delivery
Referral of high risk conditions
Time frame: Six weeks post delivery
Hypertension after hypertensive disorder of pregnancy
Time frame: 10-12 months after delivery
Dysglycaemia after a pregnancy affected by GDM
Time frame: 10-12 months after delivery
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 15 Sep 2025.
- Background: PubMed 34816187Nagraj S, Kennedy SH, Jha V, Norton R, Hinton L, Billot L, Rajan E, Arora V, Praveen D, Hirst JE. SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial. Front Glob Womens Health. 2021 May 28;2:620759. doi: 10.3389/fgwh.2021.620759. eCollection 2021.
- Derived from this study: PubMed 37559158Hirst JE, Votruba N, Billot L, Arora V, Rajan E, Thout SR, Peiris D, Patel A, Norton R, Mullins E, Sharma A, Kennedy S, Jha V, Praveen D. A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial. Trials. 2023 Aug 9;24(1):510. doi: 10.1186/s13063-023-07510-x.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified individual data and data dictionary will be made available for sharing on the day of publication of the main results. Data will be made available through a 3rd party data repository, via email request to the Principal Investigator on receipt of a signed data sharing agreement.
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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.
Jane E Hirst, MBBS MPH PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMARThealth Pregnancy in people with Anemia of Pregnancy and Gestational Diabetes, run by The George Institute at 1 site in India.
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 5 inclusion and 3 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
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?
Change anaemia prevalence in women (time frame: 10-12 months after delivery). 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 NCT05752955, 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 15 Sep 2025.