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Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia (PREMODYM)

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ClinicalTrials.gov Identifier: NCT03761888
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Mickaël Soued, Hopital Antoine Beclere

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.

Condition or disease Intervention/treatment
Preeclampsia Severe Diagnostic Test: optic nerve sheath measurement and transcranial doppler

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Group/Cohort Intervention/treatment
Labetalol
Patients who will receive labetalol in IV route in first intention
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

Nicardipine
Patients who will receive nicardipine in IV route in first intention
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




Primary Outcome Measures :
  1. Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol. [ Time Frame: just before treatment and 2 hours after ]
    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


Secondary Outcome Measures :
  1. variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route [ Time Frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours ]
    values are obtained by transcranial doppler

  2. variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route [ Time Frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours ]
    values are obtained by transcranial doppler

  3. proportion of pathologic PI in middle cerebral artery in each group [ Time Frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours ]
    values are obtained by transcranial doppler

  4. proportion of optic nerve sheath up to 5.8 mm in each group [ Time Frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours ]
    values are obtained by ultrasonography

  5. values of optic nerve sheath diameter in each group [ Time Frame: At 30 minutes to 60 minutes and 6 hours to 8 hours ]
    values are obtained by ultrasonography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with severe preeclampsia and antihypertensive drug administrated by i.v. route
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761888


Contacts
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Contact: Mickaël SOUED +33145374273 mickael.soued@aphp.fr

Locations
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France
Hôpital Béclère Recruiting
Clamart, France, 92140
Contact: Mickaël SOUED    +33145374273    mickael.soued@aphp.fr   
Sponsors and Collaborators
Hopital Antoine Beclere

Additional Information:

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Responsible Party: Dr Mickaël Soued, Principal Investigator, Hopital Antoine Beclere
ClinicalTrials.gov Identifier: NCT03761888     History of Changes
Other Study ID Numbers: 2018-A00689-46
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Labetalol
Nicardipine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents