Hypertension During Pre-Eclampsia
Conditions
Keywords
PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE
Brief summary
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).
Interventions
DRUGURAPIDIL (EUPRESSYL*)
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.
DRUGNICARDIPINE
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
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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. | 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
| Measure | Time frame |
|---|---|
| -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 | During the first 48hour of life |
Countries
France
Contacts
Primary ContactPierre Auguste DIEMUNSCH, MD
Outcome results
None listed