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

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752955
• Other study ID #: 27-21
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: The George Institute
• Contact: Eldho Baslin Rajan, Msc Nursing
• Phone: +914030994444
• Email: erajan[@]georgeinstitute.org.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3240
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• SMARThealth Pregnancy
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.

Locations

Country	Name	City	State
India	The George Institute for Global Health	Hyderabad	Telangana

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	University of Oxford

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in quality of life scores	Differences in EuroQuol 5D (EQ5D) score between baseline and at 12 months	10-12 months after delivery
Other	Differences in depression scores	Differences in Patient Health Questionnaire 9 (PHQ9) scores between baseline and at 12 months	10-12 months after delivery
Other	Differences in anxiety scores	Differences in Generalised Anxiety and Depression score 7 (GAD7) scores between baseline and at 12 months	10-12 months after delivery
Other	Infant feeding	World Health Organization Infant and Young Feeding Assessment	6 weeks after delivery and 12 months after delivery]
Other	Pregnancy intention	Difference in London Measure of Unplanned pregnancy scores	10-12 months post natal
Other	Cost of care	Direct and indirect costs of care during pregnancy and for the first six weeks after birth	6 - 10 weeks after birth
Primary	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	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
Secondary	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
Secondary	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
Secondary	Compliance with iron-folic acid supplements during pregnancy and breastfeeding	Self reported compliance with iron folic acid supplementation	10-12 months after delivery
Secondary	De-worming treatment	Proportion of women during pregnancy who receive de-worming treatment	during pregnancy
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study website