Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

Hopital Antoine Beclere60 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Preeclampsia Severe

Interventions

optic nerve sheath measurement and transcranial dopplerDIAGNOSTIC_TEST

evaluation of cerebral hemodynamics through measurement of systolic and diastolic velocities and PI in middle cerebral artery. Intracranial pressure will be appreciate by optic nerve sheath value

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Béclère

Clamart, France

RECRUITING

Outcomes

Primary Outcomes

Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.

Variation of values will be studied during a 2 hour time period, starting just before administration of either labetalol or nicardipine by i.v. route

Time frame: just before treatment and 2 hours after

Secondary Outcomes

variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route

values are obtained by transcranial doppler

Time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours

variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route

values are obtained by transcranial doppler

Time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours

proportion of pathologic PI in middle cerebral artery in each group

values are obtained by transcranial doppler

Time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours

proportion of optic nerve sheath up to 5.8 mm in each group

values are obtained by ultrasonography

Time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours

values of optic nerve sheath diameter in each group

values are obtained by ultrasonography

Time frame: At 30 minutes to 60 minutes and 6 hours to 8 hours

Central Contacts

Mickaël SOUED

CONTACT

+33145374273 mickael.soued@aphp.fr

Data from ClinicalTrials.gov

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