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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

Tracking Information
First Submitted Date November 29, 2018
First Posted Date December 3, 2018
Last Update Posted Date December 3, 2018
Actual Study Start Date November 29, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 30, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia
Official Title How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population women with severe preeclampsia and antihypertensive drug administrated by i.v. route
Condition Preeclampsia Severe
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
Study Groups/Cohorts
  • Labetalol
    Patients who will receive labetalol in IV route in first intention
    Intervention: Diagnostic Test: optic nerve sheath measurement and transcranial doppler
  • Nicardipine
    Patients who will receive nicardipine in IV route in first intention
    Intervention: Diagnostic Test: optic nerve sheath measurement and transcranial doppler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 30, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mickaël SOUED +33145374273 mickael.soued@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03761888
Other Study ID Numbers 2018-A00689-46
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr Mickaël Soued, Hopital Antoine Beclere
Study Sponsor Hopital Antoine Beclere
Collaborators Not Provided
Investigators Not Provided
PRS Account Hopital Antoine Beclere
Verification Date November 2018