Fetal sensor for placental monitoring to detect maternal, fetal and neonatal outcome
Not Applicable
- Conditions
- Health Condition 1: O098- Supervision of other high risk pregnancies
- Registration Number
- CTRI/2023/11/060228
- Lead Sponsor
- niversity College of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1.Fetal malformation
2.Fetal genetic condition
3.Multiple gestation
4.Participants unable to read and respond to questionnaires in English or Hindi (India)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>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 <br/ ><br>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 <br/ ><br>Timepoint: six months
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>Investigate RBC deformability in the umbilical vein and how it correlates with metabolic patterns and with the NIRS findings <br/ ><br>Timepoint: six months