NCT03968952

Brief Summary

Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention. Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India. Study design: Cluster randomised pilot study of 4 primary care centres (PHCs) in two diverse areas of rural India. Outcome: The primary objective of this pilot study is to address the feasibility of the SMARThealth Pregnancy intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

May 23, 2019

Last Update Submit

November 3, 2020

Conditions

Pre-EclampsiaGestational DiabetesAnemia

Keywords

Digital healthGestational DiabetesHypertensionPre-Eclampsia

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Number of eligible pregnant women successfully recruited to study in 12 months.

    12 months

  • Retention rate

    Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.

    12 months

  • Number of home visits completed by Community Health Worker

    Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.

    12 months

Secondary Outcomes (7)

  • Number of pregnant women diagnosed with gestational diabetes.

    12 months

  • Postpartum follow-up of pregnant women with gestational diabetes

    18 months

  • Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.

    12 months

  • Number of pregnant women diagnosed with severe anaemia.

    12 months

  • Mean postpartum haemoglobin

    12 months

  • +2 more secondary outcomes

Study Arms (2)

SMARThealth Pregnancy

ACTIVE COMPARATOR

The components of the SMARThealth Pregnancy intervention include: 1. Educational and Training component on high-risk pregnancy conditions, focusing on; Anaemia, Hypertensive Disorders of Pregnancy (HDPs) and Gestational diabetes mellitus (GDM). 2. An mHealth platform providing clinical decision support, lifestyle advice, recall and reminder system for Community Health Workers (CHWs) and Primary Care Physicians (PCPs). Pregnant women in the intervention group will receive 3 visits at home by their CHW, in addition to their standard antenatal and postnatal care. One visit during the third trimester of pregnancy; one during Week 1 postpartum and; one visit during Week 6 postpartum.

Other: SMARThealth Pregnancy

Enhanced Standard Care

NO INTERVENTION

The control group will receive enhanced standard antenatal and postnatal care, involving: 1. An awareness programme for pregnant women, Community Health Workers (CHWs) and Primary Care Physicians (PCPs), held at the villages within the control group Primary Health Centre (PHC) cluster (Enhanced Standard Care). The community and health professionals will receive information on the high-risk conditions of anaemia in pregnancy, HDPs and GDM as part of the awareness programme. 2. Standard antenatal and postnatal care (consisting of free monthly antenatal care, and up to 7 postnatal visits), delivered by CHWs in partnership with their PHC doctor.

Interventions

SMARThealth PregnancyOTHER

Education and Training package on high-risk pregnancies and the associated long-term cardiometabolic risks; An mHealth platform providing mobile decision support to Community Health Workers.

SMARThealth Pregnancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PHC serving population of greater than 30,000 people.
  • Administrative lead for PHC consents for the PHC to participate in the study.

You may not qualify if:

  • Administrative lead does not give consent for the PHC to participate in the study.
  • Pregnant women:
  • Age above 18 years.
  • Participant is recruited between 28-36 weeks gestation.
  • Participant is willing and able to give informed consent for participation in the study AND is:
  • Living in the villages affiliated to the PHC included in the study.
  • Pregnant women who are younger than 18 years and;
  • Pregnant women who are not recruited between 28-36 weeks' gestation
  • Pregnant women not living in villages affiliated to the study PHCs will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Institute for Global Health

Hyderabad, Telangana, India

Location

Related Publications (2)

  • Nagraj S, Kennedy S, Jha V, Norton R, Hinton L, Billot L, Rajan E, Mohammed Abdul A, Phalswal A, Arora V, Praveen D, Hirst J. A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Jul 20;7:e44362. doi: 10.2196/44362.

    PMID: 37471135DERIVED

  • 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.

    PMID: 34816187DERIVED

MeSH Terms

Conditions

Pre-EclampsiaDiabetes, GestationalAnemiaHypertension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention group cluster will use the SMARThealth Pregnancy training package and mHealth platform. The Control group will have enhanced standard antenatal and postnatal care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 30, 2019

Study Start

October 1, 2019

Primary Completion

September 14, 2020

Study Completion

November 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)