Vascular dysfunction in pregnancy (manifesting as pre-eclampsia, fetal growth restriction, or stillbirth) Pregnancy and Childbirth
Conditions
Interventions
This is a single-centre observational study with two phases as follows:
- A longitudinal case-control study carried out during late pregnancy
- A longitudinal cohort study from 12 weeks gestation unti
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
Female
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Enrolled in I-TEST 2. Age 16-50 years old 3. Able to give informed consent 4. Singleton non-anomalous viable pregnancy 5. Living in Lothian area
Exclusion criteria
Exclusion criteria: 1. Women who are not pregnant 2. Aged under 16 or over 50 years old 3. Women who are classified as Adults with Incapacity (AWI) as determined by midwife, GP or research team 4. Delivery indicated before 34 weeks (for phase one) 5. Multiple pregnancy 6. Diagnosed congenital anomaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following non-invasive cardiovascular and ultrasound Doppler blood flow outcome variables will be measured, in women enrolled in the I-TEST study, either at fortnightly intervals in late pregnancy (after 34 weeks) until birth for the case-control arm of the study (phase one), or at three-time points in pregnancy (around 12, 28 and 36 weeks) and 6 weeks postnatal for the longitudinal cohort arm of the study (phase two). Maternal cardiovascular data: 1. Heart rate, systolic and diastolic blood pressure measured using a sphygmomanometer in lying, sitting, and standing positions 2. Cardiac output +/- aortic size measured using electrocardiography (ECG) cardio-impedance or echocardiography. 3. Pulse wave velocity, including aortic central pulse wave velocity and peripheral pulse wave velocity, measured over different arterial segments using a tonometry-based device with simultaneous ECG recording Doppler ultrasound blood flow assessments: 1. Maternal uterine artery blood flow, including the pulsatility index from both uterine arteries 2. Maternal ophthalmic artery blood flow, including four indices: first peak systolic velocity, second peak systolic velocity, pulsatility index, and the ratio of second to first peak systolic velocities 3. Maternal middle cerebral artery blood flow, including the pulsatility index from both middle cerebral arteries | — |
Secondary
| Measure | Time frame |
|---|---|
| Resistance of the retinal and uteroplacental vascular beds, as predicted by personalised computational cardiovascular models, will be assessed either at fortnightly intervals in late pregnancy (after 34 weeks) until birth for the case-control arm of the study (phase one), or at three-time points in pregnancy (around 12, 28 and 36 weeks) and 6 weeks postnatal for the longitudinal cohort arm of the study (phase two). These will be generated using the cardiovascular data as described in the primary outcome measures, which will be used to parametrise distinct cardiovascular model simulations relating to each specific gestational/postnatal time points. For the longitudinal cohort arm of the study (phase two), proteinuria will be assessed as an albumin-creatinine ratio measured using immunoturbidimetry, at three time points in pregnancy (around 12, 28 and 36 weeks) and 6 weeks postnatally. Clinical outcome data will be collected postnatally from the medical record for all participants, at least two 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 cardiovascular measures, and outputs from computational simulations, in predictive outcome modelling for pregnancy complications. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactKathryn Hunt
Outcome results
None listed