E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To asses optimal treatment of hypertension of hypertensive disorders in pregnancy |
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E.1.1.1 | Medical condition in easily understood language |
To asses optimal treatment of hypertension of hypertensive disorders in pregnancy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To asses optimal treatment of hypertension of hypertensive disorders in pregnancy |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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%.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Neonatal follow up will take place until 6 weeks postpartum |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Labetalol and Nicardipine |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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6 weeks of the neonate after the last participating women giving birth |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |