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A study of Newer Methods to find out the Risk of developing High Blood Pressure (Pre-eclampsia) among Pregnant Women

A prospective cohort study to evaluate novel technologies for aiding pre-eclampsia risk screening and prediction - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/107674
Enrollment
1903
Registered
2026-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O149- Unspecified pre-eclampsia

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Concept Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women with a viable pregnancy, from 11 weeks and 0 days to less than 20 weeks gestation 2. Single or multiple gestation 3. Willing, able and consent to a follow-up cohort study 4. Intend to deliver at a participating facility 5. Pregnant women less than 18 years of age

Exclusion criteria

Exclusion criteria: 1. Pregnant women less than 11 weeks and 0 days and more than 20 weeks gestation 2. Not willing or not able and consent to a follow-up cohort study 3. Pregnant women less than 18 years of age

Design outcomes

Primary

MeasureTime frame
Central retinal artery equivalent (CRAE) Central retinal vein equivalent (CRVE) and Serum PLGF Level before 12Timepoint: between 11-20 weeks GA

Secondary

MeasureTime frame
Vessel density and tortuosity measured in terms of Presence of: arteriole narrowing, tortuosity, segmental retinal artery vasospasm, papilledema, serous retinal detachments, cotton wool spots and retinal hemorrhages Timepoint: Between 11-20 weeks of gestational age;Assessment of PlGF Blood Marker Testing in relation to Hands-on time, total turnaround time, rate of invalid results, device-related issues/malfunction and user satisfaction Timepoint: Between 11-20 weeks of gestational age;Delivery with Pre-eclampsiaTimepoint: Before 37 weeks Gestational Age;Health Care Utilization Outcomes which include: Number of antenatal visits, Referral to higher-level care, Self-reported use of aspirin & Self-reported use of calcium supplementation Timepoint: From pregnancy registration till delivery;Pre-eclampsia, Eclampsia, Maternal deathTimepoint: During enrolment and/or follow up period till discharge after delivery;Placental abruption, Severe maternal morbidity, Any Intensive care unit (ICU) admission; for more than 24 hours; duration of ICU admission, Intubation & mechanical ventilation (not for childbirth), Severe hypertension, Composite outcome on use of additional interventions for management of primary PPH (regardless of mode of birth) up until the end of the studyTimepoint: During enrolment and/or follow up period till discharge after delivery

Countries

Ghana, India, Kenya, South Africa

Contacts

Public ContactDr Shivaprasad Goudar

Jawaharlal Nehru Medical College

sgoudar@jnmc.edu9448126371

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026