Optical Monitoring of Placental Oxygenation and Metabolism

Last updated: March 13, 2025
Sponsor: University College, London
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Near Infrared spectroscopy (NIRS)

Clinical Study ID

NCT06886685
156470
  • Ages > 18
  • Female

Study 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

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 orgestational diabetes mellitus (GDM) and reactive hypoglycemia (a condition withoutcomes similar to GDM according to UCLH research) / Small for Gestational Age (SGA*) / Fetal Growth Restriction (FGR**) and postdates (>40weeks) / withsuspected or evidence of infection or inflammation)

  1. Singleton Pregnancy

  2. Participants aged 18 years or over

  • SGA criteria (as per RCOG GTG 31) - EFW <10th centile. ** FGR criteria (as perRCOG GTG 31) - EFW/AC <3rd centile, EFW/AC <10th centile with dopplerabnormalities or EFW/AC crossing 2 quartiles on growth charts + dopplerabnormalities (CPR<5%/UmA PI >95%).

Exclusion

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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Near Infrared spectroscopy (NIRS)
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • University College London Hospital - UCLH

    London, WC1E 6DB
    United Kingdom

    Active - Recruiting

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