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NCT Number: NCT05752955

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

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.

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Key information

Conditions

Anemia of Pregnancy Anemia Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Gestational Hypertension Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Pre-Eclampsia Pregnancy Complications Type 2 Diabetes Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The George Institute for Global Health

Hyderabad, Telangana, 500082, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMARThealth Pregnancy

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change the proportion of women with moderate and severe anaemia

    Time frame: 10-12 months after delivery

    Proportion of participants with moderate anaemia (Hb < 10g /dL) and severe anaemia (Hb < 8g /dL) between the intervention and control clusters

  2. Postnatal screening for type 2 diabetes after GDM

    Time frame: 10-12 months after delivery

    Proportion of women with GDM who undergo screening for type 2 diabetes in the first year after delivery

  3. Postnatal screening for hypertension after hypertensive disorder of pregnancy

    Time frame: 10-12 months after delivery

    Proportion of women with a hypertensive disorder of pregnancy screened for hypertension in the first year after delivery

  4. Compliance with iron-folic acid supplements during pregnancy and breastfeeding

    Time frame: 10-12 months after delivery

    Self reported compliance with iron folic acid supplementation

  5. De-worming treatment

    Time frame: during pregnancy

    Proportion of women during pregnancy who receive de-worming treatment

  6. Point of care Haemoglobin (Hb) testing

    Time frame: 10-12 months after delivery

    Proportion of women who have a point of care Hb test during pregnancy and in the post natal period

  7. Referral of high risk conditions

    Time frame: Six weeks post delivery

    The proportion of women detected with anaemia, hypertension or GDM correctly referred to primary or secondary care

  8. Hypertension after hypertensive disorder of pregnancy

    Time frame: 10-12 months after delivery

    Differences in systolic and diastolic blood pressure in women who were diagnosed during pregnancy with hypertensive disorder of pregnancy

  9. Dysglycaemia after a pregnancy affected by GDM

    Time frame: 10-12 months after delivery

    Difference in HbA1c, fasting and 2-hour glucose venous samples post 75 gram glucose load in those who developed GDM during pregnancy

Other outcomes

  1. Differences in quality of life scores

    Time frame: 10-12 months after delivery

    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)

  2. Differences in depression scores

    Time frame: 10-12 months after delivery

    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).

  3. Differences in anxiety scores

    Time frame: 10-12 months after delivery

    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).

  4. Infant feeding

    Time frame: 6 weeks after delivery and 12 months after delivery]

    World Health Organization Infant and Young Feeding Assessment

  5. Pregnancy intention

    Time frame: 10-12 months post natal

    Difference in London Measure of Unplanned pregnancy scores

  6. Cost of care

    Time frame: 6 - 10 weeks after birth

    Direct and indirect costs of care during pregnancy and for the first six weeks after birth

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • University of Oxford

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 3, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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