Optical Monitoring of Placental Oxygenation and Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Compromised Placental Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low Risk

Normal pregnancy with fetal gestation of 23 weeks or above

Near Infrared spectroscopy (NIRS)

Intervention Type OTHER

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%).

Near Infrared spectroscopy (NIRS)

Intervention Type OTHER

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

Interventions

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Near Infrared spectroscopy (NIRS)

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No