EUCTR2007-000727-17-NL
Active, not recruiting
Not Applicable
Maternal, uteroplacental and fetal haemodynamic effect of Nicardipine in severe pre-eclampsia. - CORCA II
ConditionsHypertensive 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, antepartumMedDRA version: 9.1Level: LLTClassification code 10053094Term: Doppler echocardiographyMedDRA version: 9.1Level: LLTClassification code 10045412Term: Ultrasound DopplerMedDRA version: 9.1Level: LLTClassification code 10058179Term: Hypertensive emergencyMedDRA version: 9.1Level: LLTClassification code 10038555Term: ReninMedDRA version: 9.1Level: LLTClassification code 10002491Term: Angiotensin IIMedDRA version: 9.1Level: LLTClassification code 10053406Term: Brain natriuretic peptideMedDRA version: 9.1Level: LLTClassification code 10001644Term: Aldosterone
DrugsCardene
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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).
- Sponsor
- Erasmus MC
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •structural cardiac anomaly
- •contra\-indication for study medication
- •indication for Intensive Care admission (ventilation support, dialysis, ...)
Outcomes
Primary Outcomes
Not specified
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