Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

• Conditions: Preeclampsia Severe
• Interventions: Diagnostic Test: optic nerve sheath measurement and transcranial doppler

• Registration Number: NCT03761888
• Lead Sponsor: Hopital Antoine Beclere

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-29
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-30
• Last Update Submitted: 2018-11-30
• Study First Posted: 2018-12-03
• Last Update Posted: 2018-12-03
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Labetalol	optic nerve sheath measurement and transcranial doppler	Patients who will receive labetalol in IV route in first intention
Nicardipine	optic nerve sheath measurement and transcranial doppler	Patients who will receive nicardipine in IV route in first intention

Primary Outcome Measures

Name	Time	Method
Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.	just before treatment and 2 hours after	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

Secondary Outcome Measures

Name	Time	Method
proportion of optic nerve sheath up to 5.8 mm in each group	just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours	values are obtained by ultrasonography
variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route	just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours	values are obtained by transcranial doppler
variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route	just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours	values are obtained by transcranial doppler
proportion of pathologic PI in middle cerebral artery in each group	just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours	values are obtained by transcranial doppler
values of optic nerve sheath diameter in each group	At 30 minutes to 60 minutes and 6 hours to 8 hours	values are obtained by ultrasonography

Trial Locations

Locations (1)

Hôpital Béclère; 🇫🇷 Clamart, France