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Fetal sensor for placental monitoring to detect maternal, fetal and neonatal outcome

Optical monitoring of placental oxygenation and metabolism - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/060228
Enrollment
400
Registered
2023-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: O098- Supervision of other high risk pregnancies

Interventions

Intervention1: Nil: NA Control Intervention1: nil: NA

Sponsors

University College of London
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with fetal gestation of 28 weeks or above with high-risk pregnancy (pre- eclampsia (PE) / pre-existing or gestational diabetes mellitus (GDM) and reactive hypoglycemia (a condition with outcomes similar to GDM according to UCLH research) / Small for Gestational Age (SGA) / Fetal Growth Restriction (FGR) and postdates ( >40 weeks)

Exclusion criteria

Exclusion criteria: 1. Fetal malformation 2. Fetal genetic condition 3. Multiple gestation 4. Participants unable to read and respond to questionnaires in English or Hindi (India)

Design outcomes

Primary

MeasureTime frame
Assess the relationship between optical markers of oxygenation and metabolism with fetoplacental compromise and outcome. Poor outcomes are defined as Small for Gestational Age or fetal growth restriction, stillbirth or poor condition of the newborn infants at birth while good outcomes indicate live birth of a healthy appropriately grown newborn infant. Development of an optical biomarker of outcome combining placental oxygenation, metabolism, fetal heart rate and fetal movement and establishing an early warning system for risk identification Identify whether placental function (oxygenation and metabolism) differs between high income countries (UCLH) and LMIC (AIIMS) and relate to the difference in the neonatal outcome Timepoint: six months

Secondary

MeasureTime frame
Investigate the associations between the optical markers of placental oxygenation and metabolism with placental growth factor, placental histological features associated with stillbirth. We will integrate placental histological features associated with stillbirth in the AI modelling to better recognize in-utero features of a placental function that correlate with postnatal pathology Investigate RBC deformability in the umbilical vein and how it correlates with metabolic patterns and with the NIRS findings Timepoint: six months

Countries

India

Contacts

Public ContactVatsla Dadhwal

All India Institute of medical Sciences, Delhi

vatslad@hotmail.com011-29576771

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026