Optical Monitoring of Placental Oxygenation and Metabolism

Recruiting

• Conditions: Compromised Placental Function

• Registration Number: NCT06886685
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-04
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compromised placental function and fetal compromise measured by optical instrumentation	through study completion, an average of 6 months	Assess the relationship between optical markers of oxygenation and metabolism with fetoplacental compromise and outcome. Poor outcomes are defined as Small for Gestational Age (SGA \<10th GAP/GROW customised centile) or FGR (fetal growth restriction, defined as EFW or AC \<10th centile OR decrease by 50 percentiles17), stillbirth (SB) or poor condition of the newborn infants at birth. Poor condition at birth, fetal death/ death before neonatal hospital discharge, neonatal brain injury syndromes, respiratory support, cardio-vascular abnormality, sepsis and retinopathy of prematurity requiring treatment), while good outcomes indicate live birth of a healthy appropriately grown newborn infant. The primary outcome will be reported with point estimate and corresponding one-sided 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Rate of placental oxygenation and metabolism during gestation	through study completion, an average of 6 months	Develop a monogram of placental oxygenation and metabolism during gestation (23-42 weeks) to characterise the placental development. Investigate the impact of different positions and postures of pregnant women on placental oxygenation.
Association between optical biomarkers and preterm labour	through study completion, an average of 6 months	Identify proportion of successful monitoring using the optical instrumentation. Combine placental oxygenation, metabolism, fetal heart rate and fetal movement and establish an early warning system for risk identification.
Measure impact of infection and inflammation on placental perfusion and metabolism as well as the newborn brain	through study completion, an average of 6 months	Associations between optical markers of placental oxygenation and metabolism with placental growth factor (PIGF); placental histological features and gene expression features associated with stillbirth.
Assess impact of fetoplacental compromise on newborn brain and neurodevelopmental follow-up	through study completion, an average of 6 months	Relationship between optical markers of placental and newborn brain oxygenation and metabolism with neonatal neurodevelopmental follow-up.
Qualitative evaluation of the feasibility and acceptability towards new technology for placental monitoring	through study completion, an average of 9 months	Interviews at the end of the study to evaluate pregnant women's approach towards the introduction of new technology for placental monitoring.

Trial Locations

Locations (1)

University College London Hospital - UCLH; 🇬🇧 London, United Kingdom