NCT03761888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 29, 2018

Last Update Submit

November 30, 2018

Conditions

Preeclampsia Severe

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route

    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

    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

    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

    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

    At 30 minutes to 60 minutes and 6 hours to 8 hours

Study Arms (2)

Labetalol

Patients who will receive labetalol in IV route in first intention

Diagnostic Test: optic nerve sheath measurement and transcranial doppler

Nicardipine

Patients who will receive nicardipine in IV route in first intention

Diagnostic Test: optic nerve sheath measurement and transcranial doppler

Interventions

optic nerve sheath measurement and transcranial dopplerDIAGNOSTIC_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

LabetalolNicardipine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • history of intracranial expansive processus, surgery or vascular disease
  • infectious state on probe placement
  • unilateral anophthalmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Béclère

Clamart, 92140, France

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Central Study Contacts

Mickaël SOUED

CONTACT

+33145374273mickael.soued@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 3, 2018

Study Start

November 29, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)