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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000727-17-NL

Enrollment

Registered

2007-03-01

Start date

2007-08-23

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1

Interventions

Trade Name: Cardene Product Name: Nicardipinehydrochloride Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NICARDIPINE HYDROCHLORIDE CAS Number: 54527843 Concentration

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate in detail the haemodynamic effects of antihypertensive treatment with Nicardipine of a hypertensive crisis in patients with severe pre-eclampsia. The effects will be investigated by maternal cardiac ultrasound and doppler ultrasound of the uteroplacental and fetal circulation.;Secondary Objective: The effects of Nicardipine treatment of a hypertensive crisis in severe pre-eclampsia on the plasma Brain Natriuretic Peptide concentration and parameters of the Renin-Angiotensin-Aldosterone system as well as the correlation of these parameters with the maternal haemodynamics ;Primary end point(s): blood pressure maternal cardiac function (systolic, diastolic) uteroplacental and fetal doppler BNP RAAS	—

Measure

Time frame

Main Objective: To investigate in detail the haemodynamic effects of antihypertensive treatment with Nicardipine of a hypertensive crisis in patients with severe pre-eclampsia. The effects will be investigated by maternal cardiac ultrasound and doppler ultrasound of the uteroplacental and fetal circulation.;Secondary Objective: The effects of Nicardipine treatment of a hypertensive crisis in severe pre-eclampsia on the plasma Brain Natriuretic Peptide concentration and parameters of the Renin-Angiotensin-Aldosterone system as well as the correlation of these parameters with the maternal haemodynamics ;Primary end point(s): blood pressure maternal cardiac function (systolic, diastolic) uteroplacental and fetal doppler BNP RAAS

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026