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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03761888
Other study ID # 2018-A00689-46
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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