Optical Monitoring of Placental Oxygenation and Metabolism
Launched by UNIVERSITY COLLEGE, LONDON · Mar 13, 2025
Trial Information
Current as of April 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called "Optical Monitoring of Placental Oxygenation and Metabolism," is studying how well the placenta is functioning during pregnancy, especially in relation to the health of the baby. The researchers want to see if a special light-based technology, known as near infrared spectroscopy (NIRS), can help them monitor the oxygen levels in the placenta and how the placenta is using that oxygen. This study will involve pregnant women who are 23 weeks or further along in their pregnancy, either with a normal or higher-risk pregnancy, and will focus on those who are 18 years and older.
If you choose to participate, you will wear a new mobile device on your abdomen during a regular hospital visit for up to one hour. This device will help gather important information about your placenta and your baby's wellbeing. To be eligible, you must be pregnant with one baby and meet certain health criteria, such as having a high-risk condition like high blood pressure or diabetes. However, if your baby has specific abnormalities, you won’t be able to participate. This study aims to improve our understanding of placental health and potentially enhance care for mothers and babies in the future.
Gender
FEMALE
Eligibility 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)
About University College, London
University College London (UCL) is a leading global research institution renowned for its commitment to advancing healthcare through innovative clinical trials. As a prominent sponsor of clinical research, UCL leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous investigations aimed at improving patient outcomes and addressing pressing medical challenges. The institution fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring that its trials adhere to the highest ethical standards and regulatory guidelines. UCL's dedication to translating scientific discoveries into practical applications underscores its role as a vital contributor to the advancement of medical science and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported