Optical Monitoring of Placental Oxygenation and Metabolism

University College London (UCL)

Status: Enrolling

Conditions: Compromised Placental Function

Treatments: Other: Near Infrared spectroscopy (NIRS)

Study type: Observational

Funder types: Other

Identifiers

NCT06886685

156470

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

500 participants in 2 patient groups

Low Risk

Description:

Normal pregnancy with fetal gestation of 23 weeks or above

Treatment:

Other: Near Infrared spectroscopy (NIRS)

High Risk

Description:

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%).

Treatment:

Other: Near Infrared spectroscopy (NIRS)