Compromised Placental FunctionNCT06886685
Optical Monitoring of Placental Oxygenation and Metabolism
An observational study of Compromised Placental Function, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Compromised Placental Function
- What is being tested?
- Near Infrared spectroscopy (NIRS)
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant females aged 18 years old or over.
Who may be able to join
- 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)
- Singleton Pregnancy
- 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%).
Who cannot join
- Fetal malformation
- Fetal genetic and structural abnormalities
- Participants unable to read and respond to questionnaires in English or Hindi (India)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital - UCLH
London, London, WC1E 6DB
Subha Mitra, Dr, 0203 447 56635 ext. 56635, subhabrata.mitra.13@ucl.ac.uk
About this study
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.
- Conditions
- Compromised Placental Function
- Being tested
- Near Infrared spectroscopy (NIRS)
- Keywords
- pregnant women, fetalsense, fetalsense monitoring, light-based technology, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared spectroscopy (NIRS)Other
NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism
| Study group | Role | What they receive |
|---|---|---|
| Low Risk | Normal pregnancy with fetal gestation of 23 weeks or above Receives: Other: Near Infrared spectroscopy (NIRS) | |
| 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%). Receives: Other: Near Infrared spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compromised placental function and fetal compromise measured by optical instrumentation
Assess the relationship between optical markers of oxygenation and metabolism with fetoplacental compromise and outcome. Poor outcomes are defined as Small for Gestational Age (SGA <10th GAP/GROW customised centile) or FGR (fetal growth restriction, defined as EFW or AC <10th centile OR decrease by 50 percentiles17), stillbirth (SB) or poor condition of the newborn infants at birth. Poor condition at birth, fetal death/ death before neonatal hospital discharge, neonatal brain injury syndromes, respiratory support, cardio-vascular abnormality, sepsis and retinopathy of prematurity requiring treatment), while good outcomes indicate live birth of a healthy appropriately grown newborn infant. The primary outcome will be reported with point estimate and corresponding one-sided 95% confidence interval.
Measured: through study completion, an average of 6 months
Secondary outcomes (5)
Rate of placental oxygenation and metabolism during gestation
Develop a monogram of placental oxygenation and metabolism during gestation (23-42 weeks) to characterise the placental development. Investigate the impact of different positions and postures of pregnant women on placental oxygenation.
Measured: through study completion, an average of 6 months
Association between optical biomarkers and preterm labour
Identify proportion of successful monitoring using the optical instrumentation. Combine placental oxygenation, metabolism, fetal heart rate and fetal movement and establish an early warning system for risk identification.
Measured: through study completion, an average of 6 months
Measure impact of infection and inflammation on placental perfusion and metabolism as well as the newborn brain
Associations between optical markers of placental oxygenation and metabolism with placental growth factor (PIGF); placental histological features and gene expression features associated with stillbirth.
Measured: through study completion, an average of 6 months
Assess impact of fetoplacental compromise on newborn brain and neurodevelopmental follow-up
Relationship between optical markers of placental and newborn brain oxygenation and metabolism with neonatal neurodevelopmental follow-up.
Measured: through study completion, an average of 6 months
Qualitative evaluation of the feasibility and acceptability towards new technology for placental monitoring
Interviews at the end of the study to evaluate pregnant women's approach towards the introduction of new technology for placental monitoring.
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2023
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compromised Placental FunctionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886685
- Sponsor's protocol ID
- 156470
- Status last verified
- Apr 2024
- First submitted
- 29 Jan 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Monitoring of Placental Oxygenation and Metabolism
- ClinicalTrials.gov ID
- NCT06886685
- Acronym / sponsor ID
- 156470
- Conditions
- Compromised Placental Function
- Keywords
- pregnant women, fetalsense, fetalsense monitoring, light-based technology, NIRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk | – | Other: Near Infrared spectroscopy (NIRS)Normal pregnancy with fetal gestation of 23 weeks or above |
| High Risk | – | Other: Near Infrared spectroscopy (NIRS)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%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant females aged 18 years old or over.
Key inclusion criteria (6 listed)
- Pregnant women with fetal gestation of 23 weeks or above with:
- Singleton Pregnancy
- Participants aged 18 years or over
Key exclusion criteria (3 listed)
- Fetal malformation
- Fetal genetic and structural abnormalities
- Participants unable to read and respond to questionnaires in English or Hindi (India)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared spectroscopy (NIRS)NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism | Other | High Risk, Low Risk |
Primary outcome
Compromised placental function and fetal compromise measured by optical instrumentation
Time frame: through study completion, an average of 6 months
Assess the relationship between optical markers of oxygenation and metabolism with fetoplacental compromise and outcome. Poor outcomes are defined as Small for Gestational Age (SGA <10th GAP/GROW customised centile) or FGR (fetal growth restriction, defined as EFW or AC <10th centile OR decrease by 50 percentiles17), stillbirth (SB) or poor condition of the newborn infants at birth. Poor condition at birth, fetal death/ death before neonatal hospital discharge, neonatal brain injury syndromes, respiratory support, cardio-vascular abnormality, sepsis and retinopathy of prematurity requiring treatment), while good outcomes indicate live birth of a healthy appropriately grown newborn infant. The primary outcome will be reported with point estimate and corresponding one-sided 95% confidence interval.
5 secondary outcomes
Rate of placental oxygenation and metabolism during gestation
Time frame: through study completion, an average of 6 months
Association between optical biomarkers and preterm labour
Time frame: through study completion, an average of 6 months
Measure impact of infection and inflammation on placental perfusion and metabolism as well as the newborn brain
Time frame: through study completion, an average of 6 months
Assess impact of fetoplacental compromise on newborn brain and neurodevelopmental follow-up
Time frame: through study completion, an average of 6 months
Qualitative evaluation of the feasibility and acceptability towards new technology for placental monitoring
Time frame: through study completion, an average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University College London Hospital - UCLH
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compromised Placental Function, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compromised placental function and fetal compromise measured by optical instrumentation (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.