Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia (PREMODYM)

Hopital Antoine Beclere

Status: Unknown

Conditions: Preeclampsia Severe

Treatments: Diagnostic Test: optic nerve sheath measurement and transcranial doppler

Study type: Observational

Funder types: Other

Identifiers

NCT03761888

2018-A00689-46

Details and patient eligibility

About

Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged up to 18 years
• patient with severe preeclampsia defined by Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of amenorrhea, associated with neurologic troubles, eclampsia of epigastric pain.
• Decision by clinician to introduce an antihypertensive therapy by oral route : either labetalol or nicardipine

Exclusion criteria

• history of intracranial expansive processus, surgery or vascular disease
• infectious state on probe placement
• unilateral anophthalmia

Trial design

60 participants in 2 patient groups

Labetalol

Description:

Patients who will receive labetalol in IV route in first intention

Treatment:

Diagnostic Test: optic nerve sheath measurement and transcranial doppler

Nicardipine

Description:

Patients who will receive nicardipine in IV route in first intention

Treatment:

Diagnostic Test: optic nerve sheath measurement and transcranial doppler