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

NCT05752955 | Completed

• 1 other identifier: 27-21
• Study Type: interventional
• Target: 3,446
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  10-12 months after delivery

Secondary Outcomes (9)

• Change the proportion of women with moderate and severe anaemia

  10-12 months after delivery

• Postnatal screening for type 2 diabetes after GDM

  10-12 months after delivery

• Postnatal screening for hypertension after hypertensive disorder of pregnancy

  10-12 months after delivery

• Compliance with iron-folic acid supplements during pregnancy and breastfeeding

  10-12 months after delivery

• De-worming treatment

  during pregnancy

Other Outcomes (6)

• Differences in quality of life scores

  10-12 months after delivery

• Differences in depression scores

  10-12 months after delivery

• Differences in anxiety scores

  10-12 months after delivery

Study Arms (2)

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

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

Interventions

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.

SMARThealth Pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The George Institute: lead
• University of Oxford: collaborator

Study Sites (1)

The George Institute for Global Health

Hyderabad, Telangana, 500082, India

Location

Related Publications (2)

• 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.

  PMID: 34816187 BACKGROUND

• Hirst 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.

  PMID: 37559158 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Anemia; Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jane E Hirst, MBBS MPH PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised trial

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: March 3, 2023
• Study Start: June 6, 2022
• Primary Completion: December 31, 2024
• Study Completion: May 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available after publication of the main study findings and will be available for an indefinite period of time
• Access Criteria: 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

Locations

IN (1)