Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine

University Hospital, Strasbourg, France72 enrolled

Overview

The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients. * efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration. * safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension During Pre-Eclampsia

Interventions

URAPIDIL (EUPRESSYL*)DRUG

Urapidil (Eupressyl\*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.

NICARDIPINEDRUG

Nicardipine : IV 6.25 mg bolus until PAD \>105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 51 Years

Medical Language ↔ Plain English

Inclusion criteria: * patients 'written informed consent dated and signed by investigator and patient * affiliation to a social security system * single pregnancy * arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe pre-eclampsia Exclusion criteria: * patient under 18 year old or unable to give informed consent * protocol rejected by patient-impossibility to use non invasive blood pressure monitoring * antihypertensive treatments within 24h before inclusion * allergy to or contraindication for one of the study drugs-pre * eclampsia that does not require an antihypertensive treatment * acute eclampsia-requirement for other drugs with potential dangerous interactions with study drugs * participation to a therapeutic protocol within 6 months prior to the start of study

Locations (4)

Hôpital Saint-Jacques, CHU de Besançon

Besançon, France

RECRUITING

Maternité A. PINARD

Nancy, France

RECRUITING

Sihcus-Cmco

Schiltigheim, France

RECRUITING

Outcomes

Primary Outcomes

Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period.

Time frame: Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period

Secondary Outcomes

-maternal and foetal ultrasonography, biology and clinical assessment-type of delivery-post-partum bleeding-neo-natal evaluation by neonatologist during the first 48 hours of life

Time frame: During the first 48hour of life

Central Contacts

Pierre Auguste DIEMUNSCH, MD

CONTACT

33.3.88.12.70.78 Pierre.Diemunsch@chru-strasbourg.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.