An interventional study of SMARThealth Pregnancy in Anemia of Pregnancy, Gestational Diabetes and Gestational Hypertension, sponsored by The George Institute. Completed at 1 site in India. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by The George Institute · Not applicable, Interventional, and Prevention
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:
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:
Recruitment commenced in Siddipet district 6 June 2022 and will commence in Haryana 1 January 2023.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 3,446 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →The George Institute is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For Primary health Centres:
Exclusion Criteria:
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
Other: SMARThealth Pregnancy
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
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.
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
Time frame: 10-12 months after delivery
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
Time frame: 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
Time frame: 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
Time frame: 10-12 months after delivery
Compliance with iron-folic acid supplements during pregnancy and breastfeeding
Self reported compliance with iron folic acid supplementation
Time frame: 10-12 months after delivery
De-worming treatment
Proportion of women during pregnancy who receive de-worming treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10-12 months after delivery
Differences in quality of life scores
Differences in EuroQuol 5D (EQ5D) score between baseline and at 12 months. The Five-item EQID uses scale of health score from 0 (worst imaginable) to 100 (best imaginable)
Time frame: 10-12 months after delivery
Differences in depression scores
Differences in Patient Health Questionnaire 9 (PHQ9) scores between baseline and at 12 months. Nine-item PHQ-9 use 4-point Likert-scaled items ranging from 0 (not at all) to 3 (nearly every day).
Time frame: 10-12 months after delivery
Differences in anxiety scores
Differences in Generalised Anxiety and Depression score 7 (GAD7) scores between baseline and at 12 months. The seven-item GAD-7 use 4-point Likert-scaled items ranging from 0 (not at all) to 3 (nearly every day).
Time frame: 10-12 months after delivery
Infant feeding
World Health Organization Infant and Young Feeding Assessment
Time frame: 6 weeks after delivery and 12 months after delivery]
Pregnancy intention
Difference in London Measure of Unplanned pregnancy scores
Time frame: 10-12 months post natal
Cost of care
Direct and indirect costs of care during pregnancy and for the first six weeks after birth
Time frame: 6 - 10 weeks after birth
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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