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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Intervention / Treatment
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* Other: SMARThealth Pregnancy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomised trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMARThealth Pregnancy<br>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<br>* 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.<br>|
| No Intervention: Active Comparator: Usual Care<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease 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 | 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 | 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 | 10-12 months after delivery | 
| Compliance with iron-folic acid supplements during pregnancy and breastfeeding | Self reported compliance with iron folic acid supplementation | 10-12 months after delivery | 
| De-worming treatment | Proportion of women during pregnancy who receive de-worming treatment | 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 | 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 | 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 | 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 | 10-12 months after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Health Workers, mobile Health, Accredited Social Health Activist, Health Systems, Cardiometabolic diseases, Screening