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NCT03968952
SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.
NA trial testing SMARThealth Pregnancy in Pre-Eclampsia in 258 participants. Completed in 1 November 2020.
14 September 2020
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 258 |
| Start date | 1 October 2019 |
| Primary completion | 14 September 2020 |
| Estimated completion | 1 November 2020 |
| Sites | 1 location across India |
Drugs / interventions tested
- SMARThealth Pregnancy
Conditions studied
- Pre-Eclampsia — all drugs for Pre-Eclampsia →
- Gestational Diabetes — all drugs for Gestational Diabetes →
- Anemia — all drugs for Anemia →
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):
-
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 -
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 -
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:
- PubMed search for NCT03968952
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SMARThealth Pregnancy
Trials testing the same drug.
- NCT05752955 — SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Yea · NA · completed
Other recruiting trials for Pre-Eclampsia
Currently open trials in the same condition.
- NCT07245056 — Fetal Fornix and Hippocampus in Pregnant Women With Early-Onset Preeclampsia · NA · recruiting
- NCT07187596 — Mortality Outcome of Controlled Hypertension · active not recruiting
- NCT06893510 — Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia · NA · recruiting
- NCT06122220 — Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia. · NA · recruiting
- NCT06779916 — Autophagy/Apoptosis Balance in Placental Vascular Pathologies · recruiting
Other University of Oxford trials
Trials by the same sponsor.
- NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
- NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
- NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
- NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
- NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03968952 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 4 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03968952.
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