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To study the cardiovasculair effects of vasodilatation by nifedipine (Adalat gastrointestinal therapeutic system) with or without plasma volume expansion with Voluven (colloid) in women with preeclampsia

To study the cardiovasculair effects of vasodilatation by nifedipine (Adalat gastrointestinal therapeutic system) with or without plasma volume expansion with Voluven (colloid) in women with preeclampsia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003143-23-NL
Enrollment
22
Registered
2006-07-05
Start date
2007-02-12
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

preeclampsia

Interventions

Trade Name: Adalat GITS Pharmaceutical Form: Capsule*

Sponsors

St Radboud UMC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: preeclampsia, gestational age 24- 34 weeks, singleton pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: known allergy to nifedipine, known cardiovasculair or renal- or liverpathology, previous treatment with antihypertensives or tocolytics, foetal distress necessitating delivery in less than 48 uur, imminent eclampsia, no informed consent from the patient or the doctor treating the patient, multiple pregnancy, unable to take tablets

Design outcomes

Primary

MeasureTime frame
Primary end point(s): observation study variabeles during 48 hours Cardiovascular variabels: systolic, diastolic and mean bloodpressure, oxygen saturation, pulse and cardiac output ( and the systemic vascular resistance). Plasmavolume-measurement.;Main Objective: The first aim is to study the cardiovascular effects of nifedipine in pregnancy in patients with preeclampsia. Our aim is to answer the following questions: Does Adalat GITS with plasmavolume expansion in patients with preeclampsia, lead significantly more often to a desired (ca 20%), controlled, reduction of the peripheral vascular resistance (calculated from the mean arterial pressure and the cardiac output) than without plasmavolume expansion? ;Secondary Objective: Secundairy aims: 1. Does Adalat GITS with plasmavolume expansion in patients with preeclampsia lead less often to a change in the doppler flow profiles of the uterina artery, the variability of the foetal hartrhythm, as a sign of changed uterine perfusion? 2. Characterization of the pharmocokinetics in patients with preeclampsia of Adalat GITS with or without plasmavolume expansion—

Countries

Netherlands

Outcome results

None listed

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