Clinical trial NCT06886685: Optical Monitoring of Placental Oxygenation and Metabolism
Official title: Optical Monitoring of Placental Oxygenation and Metabolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Compromised Placental Function
Keywords: pregnant women
fetalsense
fetalsense monitoring
light-based technology
NIRS
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females aged 18 years old or over.

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 technology, called near infrared spectroscopy (NIRS), to monitor oxygen levels in the placenta and how placental tissue is using the oxygen (metabolism) during pregnancy.

Participants will be monitored using a newly developed mobile wearable device (light-based technology), which will be placed on the abdomen of pregnant women, and they will be monitored for up to 1 hour during their hospital visit. Participants will attend hospital visits as part of their routine care and these monitoring sessions will take place at this time.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Singleton Pregnancy
3. 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 Criteria:

1. Fetal malformation
2. Fetal genetic and structural abnormalities
3. Participants unable to read and respond to questionnaires in English or Hindi (India)

Primary outcomes:
measure: Compromised placental function and fetal compromise measured by optical instrumentation
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Rate of placental oxygenation and metabolism during gestation
timeFrame: through study completion, an average of 6 months
measure: Association between optical biomarkers and preterm labour
timeFrame: through study completion, an average of 6 months
measure: Measure impact of infection and inflammation on placental perfusion and metabolism as well as the newborn brain
timeFrame: through study completion, an average of 6 months
measure: Assess impact of fetoplacental compromise on newborn brain and neurodevelopmental follow-up
timeFrame: through study completion, an average of 6 months
measure: Qualitative evaluation of the feasibility and acceptability towards new technology for placental monitoring
timeFrame: through study completion, an average of 9 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital - UCLH
Study officials:
References: