Status:
COMPLETED
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Cardiovascular Diseases
Pre-Eclampsia Onset Less Than 37 Weeks (Diagnosis)
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
Brief Summary
This is a double blind randomised controlled feasibility study investigating the effect of postnatal enalapril on cardiovascular function in women who have had preterm pre-eclampsia. Participants will...
Detailed Description
Pre-eclampsia (PE) is a condition in pregnancy, identified by a combination of high blood pressure and protein in the urine. It affects 3-5% pregnancies. Women with preterm PE (pPE; delivery before 37...
Eligibility Criteria
Inclusion
- 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
- Inability to consent
- Known cardiac disease
- Contraindication to ACE inhibitors
- Renal artery stenosis
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03466333
Start Date
September 5 2018
End Date
September 11 2020
Last Update
February 24 2021
Active Locations (1)
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1
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL