Optical Monitoring of Placental Oxygenation and Metabolism

NCT06886685 | Recruiting

• 1 other identifier: 156470
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Compromised Placental Function

Keywords

pregnant women; fetalsense; fetalsense monitoring; light-based technology; NIRS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of placental oxygenation and metabolism during gestation

  through study completion, an average of 6 months

• Association between optical biomarkers and preterm labour

  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

  through study completion, an average of 6 months

• Assess impact of fetoplacental compromise on newborn brain and neurodevelopmental follow-up

  through study completion, an average of 6 months

• Qualitative evaluation of the feasibility and acceptability towards new technology for placental monitoring

  through study completion, an average of 9 months

Study Arms (2)

Low Risk

Normal pregnancy with fetal gestation of 23 weeks or above

Other: Near Infrared spectroscopy (NIRS)

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)

Interventions

Near Infrared spectroscopy (NIRS) OTHER

NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism

High Risk; Low Risk

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women with fetal gestation of 23 weeks or above
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant females aged 18 years old or over.

You may qualify if:

• 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%).

You may not qualify if:

• Fetal malformation
• Fetal genetic and structural abnormalities
• Participants unable to read and respond to questionnaires in English or Hindi (India)

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital - UCLH

London, London, WC1E 6DB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples of whole blood, plasma and serum. Also placenta/cord blood samples

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)