Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

Preeclampsia Severe Clinical Trial

— PREMODYM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03761888
• Other study ID #: 2018-A00689-46
• Status: Recruiting
• Start date: November 29, 2018
• Est. completion date: May 2019

Study information

• Verified date: November 2018
• Source: Hopital Antoine Beclere
• Contact: Mickaël SOUED
• Phone: +33145374273
• Email: mickael.soued[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia Severe

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Béclère	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Antoine Beclere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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