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Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03761888
Acronym
PREMODYM
Enrollment
60
Registered
2018-12-03
Start date
2018-11-29
Completion date
2019-05-31
Last updated
2018-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia Severe

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.

Interventions

DIAGNOSTIC_TESToptic 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

Sponsors

Hopital Antoine Beclere
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 afterVariation 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

MeasureTime frameDescription
variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. routejust before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hoursvalues are obtained by transcranial doppler
variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. routejust before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hoursvalues are obtained by transcranial doppler
proportion of pathologic PI in middle cerebral artery in each groupjust before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hoursvalues are obtained by transcranial doppler
proportion of optic nerve sheath up to 5.8 mm in each groupjust before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hoursvalues are obtained by ultrasonography
values of optic nerve sheath diameter in each groupAt 30 minutes to 60 minutes and 6 hours to 8 hoursvalues are obtained by ultrasonography

Countries

France

Contacts

Primary ContactMickaël SOUED
mickael.soued@aphp.fr+33145374273

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026