Clinical trial NCT05752955: SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth
Official 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2023-03-03
Enrollment: 3240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease anaemia prevalence in women
timeFrame: 10-12 months after delivery
Secondary outcomes:
measure: Decrease the proportion of women with moderate and severe anaemia
timeFrame: 10-12 months after delivery
measure: Postnatal screening for type 2 diabetes after GDM
timeFrame: 10-12 months after delivery
measure: Postnatal screening for hypertension after hypertensive disorder of pregnancy
timeFrame: 10-12 months after delivery
measure: Compliance with iron-folic acid supplements during pregnancy and breastfeeding
timeFrame: 10-12 months after delivery
measure: De-worming treatment
timeFrame: during pregnancy
measure: Point of care Haemoglobin (Hb) testing
timeFrame: 10-12 months after delivery
measure: Referral of high risk conditions
timeFrame: Six weeks post delivery
measure: Hypertension after hypertensive disorder of pregnancy
timeFrame: 10-12 months after delivery
measure: Dysglycaemia after a pregnancy affected by GDM
timeFrame: 10-12 months after delivery
Other outcomes:
measure: Differences in quality of life scores
timeFrame: 10-12 months after delivery
measure: Differences in depression scores
timeFrame: 10-12 months after delivery
measure: Differences in anxiety scores
timeFrame: 10-12 months after delivery
measure: Infant feeding
timeFrame: 6 weeks after delivery and 12 months after delivery]
measure: Pregnancy intention
timeFrame: 10-12 months post natal
measure: Cost of care
timeFrame: 6 - 10 weeks after birth
Locations:
city: Hyderabad
country: India
facility: The George Institute for Global Health
state: Telangana
Study officials:
affiliation: University of Oxford
name: Jane E Hirst, MBBS MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.