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

How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study

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

Study Overview

• Status: Unknown
• Conditions: Preeclampsia Severe
• Intervention / Treatment: Diagnostic test: optic nerve sheath measurement and transcranial doppler

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • Recruiting
    • Hôpital Béclère
    • Contact: Mickaël SOUED; Phone Number: +33145374273; Email: mickael.soued@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women with severe preeclampsia and antihypertensive drug administrated by i.v. route

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Labetalol; Patients who will receive labetalol in IV route in first intention	Diagnostic test: optic nerve sheath measurement and transcranial doppler; 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
Nicardipine; Patients who will receive nicardipine in IV route in first intention	Diagnostic test: optic nerve sheath measurement and transcranial doppler; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	just before treatment and 2 hours after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	At 30 minutes to 60 minutes and 6 hours to 8 hours

Collaborators and Investigators

• Sponsor: Hopital Antoine Beclere

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 2018-A00689-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No