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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Normal pregnancy with fetal gestation of 23 weeks or above |
| |
| 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%). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared spectroscopy (NIRS) | Other | NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 6 months |
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Inclusion Criteria:
Pregnant women with fetal gestation of 23 weeks or above with:
Singleton Pregnancy
Participants aged 18 years or over
Exclusion Criteria:
Pregnant women with fetal gestation of 23 weeks or above
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Pregnant females aged 18 years old or over.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital - UCLH | Recruiting | London | London | WC1E 6DB | United Kingdom |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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samples of whole blood, plasma and serum. Also placenta/cord blood samples
| 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. | 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. | 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. | 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. | through study completion, an average of 9 months |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |