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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,446
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.
The George Institute for Global Health
Hyderabad, Telangana, India
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
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