Netherlands 2015.
Trial name or title | Early Vvascular Adjustments during hypertensive pregnancy (EVA). ClinicalTrials.gov Identifier: NCT02531490. |
Methods | Open‐label RCT. |
Participants | Target: 368 Pregnant women ages 18 years or older, before 37 weeks of gestational age, diagnosed with mild to moderate gestational hypertension. |
Interventions | Intervention arm 1: women with a hyperdynamic vasodilated profile, characterised by a mean arterial pressure/heart rate (Hr) ratio ≤ 1.1 are prescribed a beta blocker. Intervention arm 2: women with a hypodynamic vasoconstrictive profile (MAPhr ratio ≥ 1.4) are prescribed nifedipine. Intervention arm 3: women with normodynamic profile (MAP/Hr ratio in between 1.1 and 1.4) are prescribed methyldopa. Control arm: no antihypertensive. |
Outcomes | Primary outcomes: severe hypertension, pre‐eclampsia. Secondary outcomes: pattern of change of the hemodynamic profile, measured by the ratio of mean arterial pressure and heart rate; diameter aortic outflow tract and left ventricular outflow tract, left ventricular volume after diastole and systole measured by transthoracic echocardiography; number of patients with concentric left ventricular remodeling or concentric hypertrophy; Apgar score; SGA; PTB; Stillbirth, perinatal mortality, morbidity: chronic lung disease, neonatal sepsis, severe IVH > grade II, periventricular leucomalacia > grade I, and necrotizing enterocolitis. Days on ventilation support, length of admission to neonatal or intensive care nursery, and total days in hospital until 3 months corrected age: maternal and neonatal side‐effects; composite of maternal complications including: mortality, stroke, eclampsia, blindness, uncontrolled hypertension, respiratory failure, birth related variables, needed level of care. |
Starting date | December 2015. |
Contact information | Maastricht University Medical Center, Netherlands. Contact: Eva Mulder, MD (0031650504243) eva.mulder@mumc.nl Contact: Marc Spaanderman, professor (0031433874774) marc.spaanderman@mumc.nl |
Notes | Ongoing. |