Early Vascular Adjustments During Hypertensive Pregnancy (EVA)

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 4

Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced

Treatments: Drug: Labetalol; Drug: Nifedipine; Drug: Methyldopa

Study type: Interventional

Funder types: Other

Identifiers

NCT02531490

METC152017

Details and patient eligibility

About

Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.

Enrollment: 368 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ages 18years or older
• Before 37 weeks of gestational age;
• Diagnosed with mild to moderate gestational hypertension

Exclusion criteria

• Women with severe hypertension: systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg.
• Women with chronic hypertension who are already on antihypertensive drugs. If no antihypertensive drugs are used yet, women with pre-existent hypertension are eligible to participate.
• Women diagnosed with preeclampsia or eclampsia in the current pregnancy.
• Women who are not able to comprehend the study outline.
• Women who have already participated in this study cannot be included a second time.
• Women who have a (relative) contra-indication for one of the possible prescribed medications (for example women who have tested positive for antinuclear antibodies, which is a contraindication for Methyldopa).
• Women who intend to terminate the pregnancy
• Women who have a fetus with a major anomaly or chromosomal abnormality

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 3 patient groups

randomized, interventiongroup

Active Comparator group

Description:

Women with a hyperdynamic vasodilated profile, characterized by a mean arterial pressure (MAP)/ Heart rate (Hr) ratio ≤ 1.1 are prescribed a beta-blocker. Women with a hypodynamic vasoconstrictive profile (MAP/Hr ratio ≥ 1.4) are prescribed nifedipine. Women with normodynamic profile (MAP/Hr ratio in between 1.1 and 1.4) are prescribed Methyldopa.

Treatment:

Drug: Methyldopa

Drug: Nifedipine

Drug: Labetalol

randomized, control-group

No Intervention group

Description:

Women who give informed consent for randomization, and are randomized to the control group will not be medicinally treated for mild to moderate gestational hypertension.

not-randomized, control-group

No Intervention group

Description:

Women who do not want to be randomized, but who give informed consent for follow-up on their data until discharge after delivery. They will receive standard care, i.e. no medication is prescribed for mild to moderate gestational hypertension.