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SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05752955
Enrollment
3446
Registered
2023-03-03
Start date
2022-06-06
Completion date
2025-05-01
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Anemia of Pregnancy, Gestational Diabetes, Gestational Hypertension, Hypertension, Pre-Eclampsia, Type 2 Diabetes

Keywords

Community Health Workers, mobile Health, Accredited Social Health Activist, Health Systems, Cardiometabolic diseases, Screening

Brief 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. 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.

Interventions

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.

Sponsors

University of Oxford
CollaboratorOTHER
The George Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Double (Investigator, Outcomes Assessor) The investigator and outcomes assessor will be blinded to allocation group. Each cluster will be coded and using a random number generator. The sites will only be unlinked after final database lock after endpoint adjudication for analysis.

Intervention model description

Cluster randomised trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* For Primary health Centres: * located in the selected districts * provide pregnancy care * chief doctor (or equivalent) agrees to participate * For women \>12 weeks pregnant

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change anaemia prevalence in women10-12 months after deliveryProportion of participants with any degree of anaemia (non-pregnant definition Hb \< 12g/dL) between the intervention and control clusters

Secondary

MeasureTime frameDescription
Postnatal screening for type 2 diabetes after GDM10-12 months after deliveryProportion of women with GDM who undergo screening for type 2 diabetes in the first year after delivery
Postnatal screening for hypertension after hypertensive disorder of pregnancy10-12 months after deliveryProportion of women with a hypertensive disorder of pregnancy screened for hypertension in the first year after delivery
Compliance with iron-folic acid supplements during pregnancy and breastfeeding10-12 months after deliverySelf reported compliance with iron folic acid supplementation
De-worming treatmentduring pregnancyProportion of women during pregnancy who receive de-worming treatment
Point of care Haemoglobin (Hb) testing10-12 months after deliveryProportion of women who have a point of care Hb test during pregnancy and in the post natal period
Referral of high risk conditionsSix weeks post deliveryThe proportion of women detected with anaemia, hypertension or GDM correctly referred to primary or secondary care
Hypertension after hypertensive disorder of pregnancy10-12 months after deliveryDifferences in systolic and diastolic blood pressure in women who were diagnosed during pregnancy with hypertensive disorder of pregnancy
Change the proportion of women with moderate and severe anaemia10-12 months after deliveryProportion of participants with moderate anaemia (Hb \< 10g /dL) and severe anaemia (Hb \< 8g /dL) between the intervention and control clusters
Dysglycaemia after a pregnancy affected by GDM10-12 months after deliveryDifference in HbA1c, fasting and 2-hour glucose venous samples post 75 gram glucose load in those who developed GDM during pregnancy

Other

MeasureTime frameDescription
Differences in depression scores10-12 months after deliveryDifferences 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).
Differences in anxiety scores10-12 months after deliveryDifferences 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).
Infant feeding6 weeks after delivery and 12 months after delivery]World Health Organization Infant and Young Feeding Assessment
Pregnancy intention10-12 months post natalDifference in London Measure of Unplanned pregnancy scores
Cost of care6 - 10 weeks after birthDirect and indirect costs of care during pregnancy and for the first six weeks after birth
Differences in quality of life scores10-12 months after deliveryDifferences 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)

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026