Status:
RECRUITING
Optical Monitoring of Placental Oxygenation and Metabolism
Lead Sponsor:
University College, London
Conditions:
Compromised Placental Function
Eligibility:
FEMALE
18+ years
Brief Summary
The aim of this observational study is to detect changes in placental function related to the wellbeing of babies during pregnancy. The study also aims to assess the usefulness of a light-based techno...
Eligibility Criteria
Inclusion
- Pregnant women with fetal gestation of 23 weeks or above with:
- normal or low-risk pregnancy, OR
- high-risk pregnancy (hypertensive disorders (including preeclampsia (PE), pregnancy induced hypertension and essential hypertension) / 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 (\>40weeks) / with suspected or evidence of infection or inflammation)
- Singleton Pregnancy
- Participants aged 18 years or over
- SGA criteria (as per RCOG GTG 31) - EFW \<10th centile. \*\* FGR criteria (as per RCOG GTG 31) - EFW/AC \<3rd centile, EFW/AC \<10th centile with doppler abnormalities or EFW/AC crossing 2 quartiles on growth charts + doppler abnormalities (CPR\<5%/UmA PI \>95%).
Exclusion
- Fetal malformation
- Fetal genetic and structural abnormalities
- Participants unable to read and respond to questionnaires in English or Hindi (India)
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06886685
Start Date
April 1 2023
End Date
October 1 2025
Last Update
March 20 2025
Active Locations (1)
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1
University College London Hospital - UCLH
London, London, United Kingdom, WC1E 6DB