Maternal, uteroplacental and fetal haemodynamic effect of Nicardipine in severe pre-eclampsia. - CORCA II

• Conditions: Hypertensive crisis in patients with severe pre-eclampsia needs to be treated to prevent maternal and fetal complications. The maternal, uteroplacental and fetal haemodynamic respose to antihypertensive treatment with Nicardipinehydrochloride will be evaluated in detail by materal echocardiography and fetal doppler ultrasound as well as by the effect on plasma Brain Natriuretic Peptide concentration (BNP) and parameters of the Renin- Angiotensin- Aldosterone system (RAAS).; MedDRA version: 9.1Level: LLTClassification code 10040445Term: Severe pre-eclampsia, antepartum; MedDRA version: 9.1Level: LLTClassification code 10053094Term: Doppler echocardiography; MedDRA version: 9.1Level: LLTClassification code 10045412Term: Ultrasound Doppler; MedDRA version: 9.1Level: LLTClassification code 10058179Term: Hypertensive emergency; MedDRA version: 9.1Level: LLTClassification code 10038555Term: Renin; MedDRA version: 9.1Level: LLTClassification code 10002491Term: Angiotensin II; MedDRA version: 9.1Level: LLTClassification code 10053406Term: Brain natriuretic peptide; MedDRA version: 9.1Level: LLTClassification code 10001644Term: Aldosterone

• Registration Number: EUCTR2007-000727-17-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

severe pre-eclampsia
sigleton pregnancy between 23 and 35 weeks
admission in High Care obstetric ward
intra-arterial blood pressure registration
systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 110 mmHg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

structural cardiac anomaly
contra-indication for study medication
indication for Intensive Care admission (ventilation support, dialysis, ...)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified