Optical Monitoring of Placental Oxygenation and Metabolism

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.

Study Overview

• Status: Recruiting
• Conditions: Compromised Placental Function
• Intervention / Treatment: Other: Near Infrared spectroscopy (NIRS)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 6DB
    • Recruiting
    • University College London Hospital - UCLH
    • Contact: Subha Mitra, Dr; Phone Number: 56635 0203 447 56635; Email: subhabrata.mitra.13@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant females aged 18 years old or over.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low Risk; Normal pregnancy with fetal gestation of 23 weeks or above	Other: Near Infrared spectroscopy (NIRS); NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism
High Risk; high-risk pregnancy with fetal gestation of 23 weeks or above with 1 or more of the following issues - hypertensive disorders (including pre-eclampsia (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. *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%).	Other: Near Infrared spectroscopy (NIRS); NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compromised placental function and fetal compromise measured by optical instrumentation	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.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of placental oxygenation and metabolism during gestation	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.	through study completion, an average of 6 months
Association between optical biomarkers and preterm labour	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.	through study completion, an average of 6 months
Measure impact of infection and inflammation on placental perfusion and metabolism as well as the newborn brain	Associations between optical markers of placental oxygenation and metabolism with placental growth factor (PIGF); placental histological features and gene expression features associated with stillbirth.	through study completion, an average of 6 months
Assess impact of fetoplacental compromise on newborn brain and neurodevelopmental follow-up	Relationship between optical markers of placental and newborn brain oxygenation and metabolism with neonatal neurodevelopmental follow-up.	through study completion, an average of 6 months
Qualitative evaluation of the feasibility and acceptability towards new technology for placental monitoring	Interviews at the end of the study to evaluate pregnant women's approach towards the introduction of new technology for placental monitoring.	through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pregnant women; NIRS; fetalsense; fetalsense monitoring; light-based technology
• Other Study ID Numbers: 156470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No