Can eye imaging in pregnancy help predict stillbirth?

I-TEST: Novel Biomarkers in Pregnancy for Early Prediction of Stillbirth

Registry ID
ISRCTN40843826
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Accord (United Kingdom)
Enrollment
650
Start date
2023-12-01
Completion date
2028-10-01
Last update
2026-08-17

Conditions

Summary

Stillbirth and pregnancy complications linked to stillbirth risk (pre-eclampsia and fetal growth restriction)

Detailed description

This is a single-centre observational study with two parallel cohorts as follows: 1. A longitudinal cohort with serial multimodal retinal imaging at 12 (+/-3) and 36 (+/-3) weeks, or at 20 (+/-3) and 36 (+/-3) weeks, in unselected pregnancies (cohort 1). 2. A cross-sectional cohort with multimodal retinal imaging in late pregnancy obtained at 36 (+/-3) weeks, in a cohort enriched with higher risk pregnancies (cohort 2). Participants from both cohorts will be invited to a single follow-up visit at 12 (+/-6) months postpartum, for repeat retinal imaging and cardiovascular assessment. Multimodal retinal imaging will be carried out at each study timepoint for both cohorts, comprising colour fundus photography, scanning laser ophthalmoscopy, optical coherence tomography, and optical coherence tomography angiography. In addition, at the 36-week study visit for both cohorts, supplementary maternal ultrasound assessments may be carried out including measurements of maternal and fetal Doppler indices and capture of research images of the placenta and fetus. Blood samples will also be collected at this 36-weeks appointment, and stored for future measurement of biomarkers of placental dysfunction, maternal vascular dysfunction, and stillbirth. Key maternal demographics and maternal and neonatal outcomes for all participants will be collected at birth from the electronic health record. The 12-month follow up study visit will comprise multimodal retinal imaging as described above, maternal cardiovascular assessment (including verbal report of smoking status and family history of cardiovascular disease, echocardiography, and measurement of height, weight, blood pressure, pulse wave velocity, and 24-hour ambulatory blood pressure and arterial stiffness). We will collect and store postnatal blood samples for measurement of biomarkers of cardiovascular dysfunction and urine samples for analysis of proteinuria (albumin-creatinine ratio) and storage for measurement of other poten

Interventions

Inclusion criteria

1. Age 16-50 years 2. Able to give informed consent 3. Singleton pregnancy 4. 12 (+/- 3) weeks gestation or 20 (+ / - 3) weeks gestation (cohort 1) 5. >23 weeks gestation (cohort 2) 6. Living in Lothian area

Exclusion criteria

1. Women who are not pregnant 2. Women aged under 16 years or over 50 years 3. Women who are classified as Adults with Incapacity (AWI) as determined by midwife, GP or research team 4. Multiple pregnancy

Locations

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