Hypertension During Pre-Eclampsia Clinical Trial
Official title:
Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE
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).
| Status | Recruiting |
| Enrollment | 72 |
| Est. completion date | August 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 51 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Saint-Jacques, CHU de Besançon | BESANçON | |
| France | Maternité A. PINARD | Nancy | |
| France | Sihcus-Cmco | Schiltigheim | |
| France | Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | -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 | Yes |