Preeclampsia SeverePREMODYMNCT03761888
Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia
An observational study of Preeclampsia Severe, run by Hopital Antoine Beclere at 1 site in France.
Trial summary
Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia Severe
- What is being tested?
- optic nerve sheath measurement and transcranial doppler
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2018to May 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with severe preeclampsia and antihypertensive drug administrated by i.v. route
Who may be able to join
- 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
Who cannot join
- history of intracranial expansive processus, surgery or vascular disease
- infectious state on probe placement
- unilateral anophthalmia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Béclère
Clamart, 92140
Mickaël SOUED, +33145374273, mickael.soued@aphp.fr
About this study
Official title: How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study
Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.
- Conditions
- Preeclampsia Severe
- Being tested
- optic nerve sheath measurement and transcranial doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Labetalol | Patients who will receive labetalol in IV route in first intention Receives: Diagnostic Test: optic nerve sheath measurement and transcranial doppler | |
| Nicardipine | Patients who will receive nicardipine in IV route in first intention Receives: Diagnostic Test: optic nerve sheath measurement and transcranial doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
values are obtained by transcranial doppler
Measured: 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
values are obtained by transcranial doppler
Measured: 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
values are obtained by transcranial doppler
Measured: 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
values are obtained by ultrasonography
Measured: 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
values are obtained by ultrasonography
Measured: At 30 minutes to 60 minutes and 6 hours to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start29 Nov 2018
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hopital Antoine Beclere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mickaël Soued, Hopital Antoine Beclere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761888
- Sponsor's protocol ID
- 2018-A00689-46
- Acronym
- PREMODYM
- Status last verified
- Nov 2018
- First submitted
- 29 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study
- ClinicalTrials.gov ID
- NCT03761888
- Acronym / sponsor ID
- PREMODYM / 2018-A00689-46
- Conditions
- Preeclampsia Severe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hopital Antoine BeclereUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labetalol | – | Diagnostic Test: optic nerve sheath measurement and transcranial dopplerPatients who will receive labetalol in IV route in first intention |
| Nicardipine | – | Diagnostic Test: optic nerve sheath measurement and transcranial dopplerPatients who will receive nicardipine in IV route in first intention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with severe preeclampsia and antihypertensive drug administrated by i.v. route
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- history of intracranial expansive processus, surgery or vascular disease
- infectious state on probe placement
- unilateral anophthalmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optic nerve sheath measurement and transcranial dopplerevaluation 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 | Diagnostic test | Labetalol, Nicardipine |
Primary outcome
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
5 secondary outcomes
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
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
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
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 of optic nerve sheath diameter in each group
Time frame: At 30 minutes to 60 minutes and 6 hours to 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia Severe, run by Hopital Antoine Beclere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mickaël SOUED (+33145374273, mickael.soued@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.