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 Type
OBSERVATIONAL
Enrollment
500
NIRS is used as a non-invasive light-based optical technology to measure placental oxygenation and metabolism
University College London Hospital - UCLH
London, London, United Kingdom
RECRUITINGCompromised 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.
Time frame: through study completion, an average of 6 months
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.
Time frame: 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.
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
Associations between optical markers of placental oxygenation and metabolism with placental growth factor (PIGF); placental histological features and gene expression features associated with stillbirth.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 9 months
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