Monitoring placental oxygen levels during pregnancy
Optical Monitoring of Placental Oxygenation and Metabolism
This study is testing a new way to monitor oxygen levels in the placenta during pregnancy to see how it affects the health of babies, using a device that pregnant women wear on their belly during check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06886685 on ClinicalTrials.gov |
What this trial studies
This observational study aims to detect changes in placental function that may affect the wellbeing of babies during pregnancy. It utilizes a light-based technology called near infrared spectroscopy (NIRS) to monitor oxygen levels and metabolism in the placenta. Pregnant women will wear a mobile device on their abdomen during routine hospital visits, allowing for up to one hour of monitoring. The study focuses on both normal and high-risk pregnancies to assess the effectiveness of this monitoring approach.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 and over, with a singleton pregnancy at 23 weeks gestation or later, either with normal or high-risk conditions.
Not a fit: Patients with fetal malformations or genetic and structural abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into placental health, potentially improving outcomes for at-risk pregnancies.
How similar studies have performed: While the use of NIRS for monitoring placental function is a novel approach, similar technologies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
London
- University College London Hospital - UCLH — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.