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NCT03968952

SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.

Completed NA Last updated 4 November 2020
What this trial tests

NA trial testing SMARThealth Pregnancy in Pre-Eclampsia in 258 participants. Completed in 1 November 2020.

Timeline
1 October 2019
Primary endpoint
14 September 2020
1 November 2020

Quick facts

Lead sponsorUniversity of Oxford
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment258
Start date1 October 2019
Primary completion14 September 2020
Estimated completion1 November 2020
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

18 and older, any sex, with Pre-Eclampsia or Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial.
    Nagraj S, Kennedy S, Jha V, Norton R, et al · · 2023 · cited 14× · PMID 37471135 · DOI 10.2196/44362
  2. 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.
    Nagraj S, Kennedy SH, Jha V, Norton R, et al · · 2021 · cited 10× · PMID 34816187 · DOI 10.3389/fgwh.2021.620759
  3. Digital tracking, provider decision support systems, and targeted client communication via mobile devices to improve primary health care.
    Agarwal S, Chin WY, Vasudevan L, Henschke N, et al · · 2025 · cited 9× · PMID 40193137 · DOI 10.1002/14651858.cd012925.pub2

Verify or expand the search:

Other trials of SMARThealth Pregnancy

Trials testing the same drug.

Other recruiting trials for Pre-Eclampsia

Currently open trials in the same condition.

Other University of Oxford trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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