Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

NCT ID: NCT03761888

Last Updated: 2018-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-29

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Preeclampsia Severe

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Labetalol

Patients who will receive labetalol in IV route in first intention

optic nerve sheath measurement and transcranial doppler

Intervention Type DIAGNOSTIC_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

Nicardipine

Patients who will receive nicardipine in IV route in first intention

optic nerve sheath measurement and transcranial doppler

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Antoine Beclere

OTHER

Sponsor Role lead

Responsible Party

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Dr Mickaël Soued

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpital Béclère

Clamart, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mickaël SOUED

Role: CONTACT

+33145374273

Facility Contacts

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Mickaël SOUED

Role: primary

+33145374273

Other Identifiers

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2018-A00689-46

Identifier Type: -

Identifier Source: org_study_id

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