Preeclampsia SeverePhase 1/2NCT06360601
Intravenous Labetalol Versus Hydralazine in Preeclampsia
A Phase 1/2 study testing Labetalol Injection and HydrALAZINE Injection in people with Preeclampsia Severe, run by Tanta University at 1 site in Egypt.
Trial summary
We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Preeclampsia Severe
- What is being tested?
- Labetalol Injection and HydrALAZINE Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 20 Dec 2024
- Phase
- Phase 1/2
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patient with clinical diagnosis of sever preeclampsia
Who cannot join
- Patient with history of previous intracranial lesion Patient with history of heart disease/allergy to drug Patient with history of arrhythmia/anticoagulation Any craniotemporal lesion
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta Univeristy hospitals
Tanta
aymen algamry, 201008018208, ielnaggar63@yahoo.com
About this study
Official title: The Effect of Intravenous Infusion of Labetalol Versus Hydralazine on Cerebral Hemodynamics of Preeclampsia Patients Prospective Randamized Study
We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome
- Conditions
- Preeclampsia Severe
- Being tested
- Labetalol Injection, HydrALAZINE Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetalol InjectionDrug
Labetalol intravenous infusion 20ml/hr
HydrALAZINE InjectionDrug
Hydralazine intravenous infusion 5mg/hr
| Study group | Role | What they receive |
|---|---|---|
| Labetalol group | Active comparator | Not described Receives: Drug: Labetalol Injection |
| Hydralazine group | Active comparator | Not described Receives: Drug: HydrALAZINE Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Mean cerebral blood flow and cerebral perfusion pressure
Measured: Pre intervention-after one hour of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2024
- Primary completion20 Nov 2024
- Study completion20 Dec 2024 (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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Kamal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360601
- Sponsor's protocol ID
- 36264PR589/3/24
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Infusion of Labetalol Versus Hydralazine on Cerebral Hemodynamics of Preeclampsia Patients Prospective Randamized Study
- ClinicalTrials.gov ID
- NCT06360601
- Acronym / sponsor ID
- 36264PR589/3/24
- Conditions
- Preeclampsia Severe
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 11 Apr 2024 (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.
We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labetalol group | Active comparator | Drug: Labetalol Injection |
| Hydralazine group | Active comparator | Drug: HydrALAZINE Injection |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient with clinical diagnosis of sever preeclampsia
Key exclusion criteria (2 listed)
- Patient with history of previous intracranial lesion Patient with history of heart disease/allergy to drug Patient with history of arrhythmia/anticoagulation Any craniotemporal lesion
- -
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 |
|---|---|---|
| Labetalol InjectionLabetalol intravenous infusion 20ml/hr | Drug | Labetalol group |
| HydrALAZINE InjectionHydralazine intravenous infusion 5mg/hr | Drug | Hydralazine group |
Primary outcome
Cerebral blood flow
Time frame: Pre intervention-after one hour of intervention
Mean cerebral blood flow and cerebral perfusion pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Yes
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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?
A Phase 1/2 study testing Labetalol Injection and HydrALAZINE Injection in people with Preeclampsia Severe, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 2 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 2 Dec 2024. 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 Egypt. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 shimaa zahraa (201550273707, Meikamal89@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: Pre intervention-after one hour of intervention). 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 2 Dec 2024.