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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urapidil | Active Comparator |
| |
| Nicardipine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Auguste DIEMUNSCH, MD | Contact | 33.3.88.12.70.78 | Pierre.Diemunsch@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Auguste DIEMUNSCH, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Jacques, CHU de Besançon | Recruiting | Besançon | 25000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26148170 | Derived | Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available. |
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| NICARDIPINE | Drug | 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 |
|
| Maternité A. PINARD | Recruiting | Nancy | 54042 | France |
|
| Sihcus-Cmco | Recruiting | Schiltigheim | 67303 | France |
|
| Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67098 | France |
|
| ID | Term |
|---|---|
| C015568 | urapidil |
| D009529 | Nicardipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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