Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT03466333
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of pPE in this pregnancy requiring delivery \< 37 weeks gestation: new or worsening hypertension \>20 weeks with proteinuria or other features suggestive of PE (abnormal haematological, biochemical parameters, fetal growth restriction (FGR) and/or abnormal sFlt:PlGF (\>85)).
* Biochemical / haematological cut-offs:
* Platelet count \<100 x109/L
* Alanine amino transferase \> 50units/L
* Creatinine \>90mmol/L
* FGR:
* Abdominal circumference (AC) / estimated fetal weight (EFW) \<3rd centile
* Or 2 of the following:
* AC/EFW \<10th centile
* AC/EFW crossing centiles by \>2 quartiles
* Cerebroplacental ratio \<5th centile
* Umbilical artery PI \>95th centile
* At time of randomisation:
* Postpartum, within 3 days of delivery
* Aged 18 years or over
* Able to provide informed consent
* Serum creatinine \<100 mmol/l
Exclusion Criteria:
* Inability to consent
* Known cardiac disease
* Contraindication to ACE inhibitors
* Renal artery stenosis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT03466333
Study Brief:
Protocol Section:
NCT03466333