To asses optimal treatment of hypertension of hypertensive disorders in pregnancy
Conditions
Interventions
Product Name: Labetalol
Product Code: C07AG01
Pharmaceutical Form: Infusion
Trade Name: Nicardipine
Product Name: Nicardipine
Product Code: C08CA04
Pharmaceutical Form: Infusion
Sponsors
VU Medical Center, Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: - Pregnant women - >18 years of age - pregnant women with severe pregnancy induced hypertension (PIH) or severe pre-eclampsia (PE) at any gestational age. Preeclampsia is defined as hypertension with proteinuria = 0.3 g/24 hrs. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 472 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Maternal age at eligibility <18 years - Fetal abnormalities - Multiple pregnancy in current pregnancy - Clinically relevant pulmonary edema, defined as pulmonary failure or distress requiring oxygen supplementation (more than 10 liters) and/or pulse oximetry of <94%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses optimal treatment of hypertension of hypertensive disorders in pregnancy;Secondary Objective: The main maternal outcome will be defined as a composite of the occurrence of eclamptic seizures, cerebral hemorrhage, liver hematoma and rupture, pulmonary edema, admission to the intensive care for ventilation or necessity for intra-arterial monitoring and maternal death. Other outcomes are inadequate control of blood pressure, necessity to use additional or switch to other antihypertensive medication than trial medication, time interval required to achieve the target blood pressure and number of doses needed for blood pressure control. The target of antihypertensive treatment is to achieve a mean arterial pressure (MAP) below 125 mmHg or diastolic pressures between 85 and 105 mmHg and systolic pressures between 130 and 155 mmHg within 2 hours after starting medication (according to the Canadian guidelines whereas no time limit is mentioned in the Dutch guidelines;Primary end point(s): The main outcome measure is a composite adverse neonatal outcome. The consideration of the composite outcome as primary outcome is based on the results of high prevalence of iatrogenic preterm delivery as a result of maternal threat during pregnancy of inadequate blood pressure control. The neonatal morbidity is more prevalent and has a serious long-term impact on the patient’s and society. ;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The main maternal outcome will be defined as a composite of the occurrence of eclamptic seizures, cerebral hemorrhage, liver hematoma and rupture, pulmonary edema, admission to the intensive care for ventilation or necessity for intra-arterial monitoring and maternal death. Other outcomes are inadequate control of blood pressure, necessity to use additional or switch to other antihypertensive medication than trial medication, time interval required to achieve the target blood pressure and number of doses needed for blood pressure control. The target of antihypertensive treatment is to achieve a mean arterial pressure (MAP) below 125 mmHg or diastolic pressures between 85 and 105 mmHg and systolic pressures between 130 and 155 mmHg within 2 hours after starting medication (according to the Canadian guidelines whereas no time limit is mentioned in the Dutch guidelines 14;Timepoint(s) of evaluation of this end point: Neonatal follow up will take place until 6 weeks postpartum | — |
Countries
Netherlands
Contacts
Public ContactAcademic Hospital
VU Medical CEnter
Outcome results
None listed