Stillbirth and pregnancy complications linked to stillbirth risk (pre-eclampsia and fetal growth restriction) Pregnancy and Childbirth
Conditions
Interventions
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
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
Female
Age
16 Years to 50 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Multimodal retinal imaging (colour fundus photography, scanning laser ophthalmoscopy, optical coherence tomography, and optical coherence tomography angiography) will be carried out at 36 weeks gestation and 12 months postpartum (cohort 1), or at 12 or 20 weeks gestation, 36 weeks gestation, and 12 months postpartum (cohort 2). Automated analysis of retinal images at all timepoints will be carried out to generate retinal vascular metrics including: 1.1. Measures of retinal vessel calibre 1.2. Measures of retinal vessel tortuosity 1.3. Measures of retinal vessel branching complexity 1.4. Measures of choroid thickness and volume 2. Clinical outcome data will be collected postnatally from the medical record for all participants, at least 2 weeks following birth. These will relate to the occurrence of pregnancy complications and birth outcomes, including birthweight, gestation at birth, mode of birth, indication for delivery, neonatal unit admission, respiratory distress, Apgar scores and umbilical cord pH levels. Collection of clinical outcome data will allow us to use the collected retinal imaging-derived measures in predictive outcome modelling for pregnancy complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Supplementary maternal ultrasound assessment will be carried out at 36 weeks' gestation for participants in both cohorts, and will include measurement of bilateral uterine artery Doppler, umbilical artery Dopplers, fetal middle cerebral artery Doppler, and capture of B-mode cross-sectional images of the placenta, fetal thorax, and fetal liver. 2. Blood samples will be collected at 36 weeks' gestation for both cohorts, for storage and future measurement of biomarkers of placental dysfunction. 3. At the 12-month postnatal follow up visit, the following supplementary data will be collected in addition to the multimodal retinal imaging previously described: 3.1. Measures of maternal cardiovascular health, including height, weight, blood pressure, pulse wave velocity, and 24 hour ambulatory blood pressure and arterial stiffness 3.2. Self report of smoking status and family history of cardiovascular disease 3.3. Echocardiography, including measurement of cardiac output, left ventricular geometry, and left ventricular systolic and diastolic function 3.4. Blood sample for storage and measurement of markers of cardiovascular dysfunction 3.5. Urine sample for measurement of proteinuria by immunoturbidimetry and storage for future measurement of markers of cardiovascular dysfunction | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactRebecca Reynolds
Outcome results
None listed