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

Primary Purpose

Anemia of Pregnancy, Gestational Diabetes, Gestational Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SMARThealth Pregnancy
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia of Pregnancy focused on measuring Community Health Workers, mobile Health, Accredited Social Health Activist, Health Systems, Cardiometabolic diseases, Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The George Institute for Global HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMARThealth Pregnancy

Active Comparator: Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Compliance with iron-folic acid supplements during pregnancy and breastfeeding
Self reported compliance with iron folic acid supplementation
De-worming treatment
Proportion of women during pregnancy who receive de-worming treatment
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
Referral of high risk conditions
The proportion of women detected with anaemia, hypertension or GDM correctly referred to primary or secondary care
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
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

Full Information

First Posted
December 21, 2022
Last Updated
February 21, 2023
Sponsor
The George Institute
Collaborators
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05752955
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomised trial
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
3240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMARThealth Pregnancy
Arm Type
Experimental
Arm Description
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
Arm Title
Active Comparator: Usual Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
SMARThealth Pregnancy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease anaemia prevalence in women
Description
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
Secondary Outcome Measure Information:
Title
Decrease the proportion of women with moderate and severe anaemia
Description
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
Title
Postnatal screening for type 2 diabetes after GDM
Description
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
Title
Postnatal screening for hypertension after hypertensive disorder of pregnancy
Description
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
Title
Compliance with iron-folic acid supplements during pregnancy and breastfeeding
Description
Self reported compliance with iron folic acid supplementation
Time Frame
10-12 months after delivery
Title
De-worming treatment
Description
Proportion of women during pregnancy who receive de-worming treatment
Time Frame
during pregnancy
Title
Point of care Haemoglobin (Hb) testing
Description
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
Title
Referral of high risk conditions
Description
The proportion of women detected with anaemia, hypertension or GDM correctly referred to primary or secondary care
Time Frame
Six weeks post delivery
Title
Hypertension after hypertensive disorder of pregnancy
Description
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
Title
Dysglycaemia after a pregnancy affected by GDM
Description
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
Other Pre-specified Outcome Measures:
Title
Differences in quality of life scores
Description
Differences in EuroQuol 5D (EQ5D) score between baseline and at 12 months
Time Frame
10-12 months after delivery
Title
Differences in depression scores
Description
Differences in Patient Health Questionnaire 9 (PHQ9) scores between baseline and at 12 months
Time Frame
10-12 months after delivery
Title
Differences in anxiety scores
Description
Differences in Generalised Anxiety and Depression score 7 (GAD7) scores between baseline and at 12 months
Time Frame
10-12 months after delivery
Title
Infant feeding
Description
World Health Organization Infant and Young Feeding Assessment
Time Frame
6 weeks after delivery and 12 months after delivery]
Title
Pregnancy intention
Description
Difference in London Measure of Unplanned pregnancy scores
Time Frame
10-12 months post natal
Title
Cost of care
Description
Direct and indirect costs of care during pregnancy and for the first six weeks after birth
Time Frame
6 - 10 weeks after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eldho Baslin Rajan, Msc Nursing
Phone
+914030994444
Email
erajan@georgeinstitute.org.in
First Name & Middle Initial & Last Name or Official Title & Degree
Praveen Devarsetty, MBBS MPH PhD
Phone
+914030994444
Email
dpraveen@georgeinstitute.org.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane E Hirst, MBBS MPH PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
The George Institute for Global Health
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudhir Thout,, PhD
Phone
+914030994444
Email
traj@georgeinstitute.org.in

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All de-identified individual data and data dictionary will be made available for sharing on the day of publication of the main results. 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.
IPD Sharing Time Frame
Data will become available after publication of the main study findings and will be available for an indefinite period of time
IPD Sharing 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
Citations:
PubMed Identifier
34816187
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.
Results Reference
background
Links:
URL
https://www.wrh.ox.ac.uk/research/smarthealth-pregnancy-improving-women2019s-life-long-health-in-rural-india
Description
Study website

Learn more about this trial

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

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