Severe Pre-eclampsiaNCT06385600
Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.
A study testing Labetalol and Phentolamine in people with Severe Pre-eclampsia, run by Assiut University.
Trial summary
The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Severe Pre-eclampsia
- What is being tested?
- Labetalol and Phentolamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 20 Mar 2026
- Phase
- Interventional
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Pregnant woman with severe preeclampsia diagnosed by obstetric doctor
- Patients willing to participate in the study
- Age above 18 yrs
Who cannot join
- • Patients with eminent eclampsia
- The history of optic neuritis
- Severe myopia
- History of ocular surgeries
- Presence of ocular ulcers
- Any clinical or morphological conditions that prevent the ultrasound examination of the orbital area
- Age below 18 yrs
About this study
Official title: Intravenous Labetalol Versus Phentolamine for the Management of Severe Preeclampsia , Randomized Controlled Clinical Trial
The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension
Read the detailed description
Non-invasive assessment of cerebral haemodynamics using Transcranial doppler ultrasonography has recently gained importance. Essentially, TCD measures flow velocity in the insonated vessel and the changes in flow velocity can be taken to reflect the changes in blood flow, assuming that the diameter of the insonated vessel remains constant. As TCD is easy to use and gives reproducible measurements, it has become a widely accepted method of assessing the cerebrovascular reactivity to carbon dioxide (CRCO2), cerebral autoregulation, estimated CPP, and CrCP. In patients with neurological disorders, impairment in both cerebral autoregulation and cerebral vascular reactivity has been shown to predict poor neurological outcome. Knowledge of the effects of normal pregnancy and pre-eclampsia on cerebral haemodynamics is essential for appropriate management of these patients undergoing anaesthesia or in labour, particularly when vasoactive medications are administered. The effects of pregnancy and/or pre-eclampsia on MCAFV have been studied by other investigators. Ikeda and colleagues found little change in mean MCAFV during the first two trimesters but reduced values in the third trimester. Williams and Wilson showed that MCAFV fell significantly with advancing gestational age. In another study, Williams and Wilson used TCD to assess cerebral haemodynamics in 17 non-pregnant women, 17 normotensive pregnant women, 20 pregnant women with pre-existing hypertension, and 21 pre-eclamptic women. The pregnant women were all in their third trimester. There was no difference in mean MCAFV in healthy pregnancy compared with non-pregnant women and a small, but non-significant, increase in mean MCAFV in the hypertensive and pre-eclamptic women. Demarin and colleagues studied pre-eclamptic women before and after delivery and found a progressive increase in MCAFV during late pregnancy. Ohno and colleagues compared MCAFV in 35 healthy pregnant and 17 pre-eclamptic women. In this study, the mean MCAFV was significantly higher in the pre-eclamptic group. It has been suggested that these increases in MCAFV are because of a degree of vasospasm. The differences between the findings of various studies with regards to the changes in MCAFV in pre-eclampsia might be explained by the differences in the severity of pre-eclampsia between the studies. Some investigators have reported increased MCAFV in symptomatic, compared with asymptomatic pre-eclamptics.
- Conditions
- Severe Pre-eclampsia
- Being tested
- Labetalol, Phentolamine
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Also called trandate, Gsk
Group L will recieve labetalol intravenous infusion (Trandate, Gsk) in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication is 5 ml/hr for an 80 Kg patient.
PhentolamineDrug
Also called Rogitamine
Group P will receive phentolamine intravenous infusion (Rogitamine) in a concentration of 10 mg/ml, thus 1 µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient.
| Study group | Role | What they receive |
|---|---|---|
| labetalol in the managment of severe preeclampsia | Active comparator | labetalol intravenous infusion (Trandate, Gsk) in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication is 5 ml/hr for an 80 Kg patient Receives: Drug: Labetalol |
| phentolamine in the managment of severe preeclampsia | Active comparator | phentolamine intravenous infusion (Rogitamine) in a concentration of 10 mg/ml, thus 1 µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient Receives: Drug: Phentolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring.
Singleton pregnant women who suffered from late onset preeclampsia will be enrolled and subjected to baseline Transcranial doppler (TCD) evaluation to measure middle cerebral artery (MCA) blood flow indices including mean flow velocity (cm/s).
Measured: 6 hours
Secondary outcomes (1)
The effect of labetalol and phentolamine on blood pressure of the patients
through measuring the blood pressure in (mmHg)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start20 May 2024 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385600
- Sponsor's protocol ID
- severe preeclampsia
- Status last verified
- Apr 2024
- First submitted
- 8 Feb 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Labetalol Versus Phentolamine for the Management of Severe Preeclampsia , Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06385600
- Acronym / sponsor ID
- severe preeclampsia
- Conditions
- Severe Pre-eclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 26 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.
The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension
Detailed description
Non-invasive assessment of cerebral haemodynamics using Transcranial doppler ultrasonography has recently gained importance. Essentially, TCD measures flow velocity in the insonated vessel and the changes in flow velocity can be taken to reflect the changes in blood flow, assuming that the diameter of the insonated vessel remains constant. As TCD is easy to use and gives reproducible measurements, it has become a widely accepted method of assessing the cerebrovascular reactivity to carbon dioxide (CRCO2), cerebral autoregulation, estimated CPP, and CrCP. In patients with neurological disorders, impairment in both cerebral autoregulation and cerebral vascular reactivity has been shown to predict poor neurological outcome. Knowledge of the effects of normal pregnancy and pre-eclampsia on cerebral haemodynamics is essential for appropriate management of these patients undergoing anaesthesia or in labour, particularly when vasoactive medications are administered. The effects of pregnancy and/or pre-eclampsia on MCAFV have been studied by other investigators. Ikeda and colleagues found little change in mean MCAFV during the first two trimesters but reduced values in the third trimester. Williams and Wilson showed that MCAFV fell significantly with advancing gestational age. In another study, Williams and Wilson used TCD to assess cerebral haemodynamics in 17 non-pregnant women, 17 normotensive pregnant women, 20 pregnant women with pre-existing hypertension, and 21 pre-eclamptic women. The pregnant women were all in their third trimester. There was no difference in mean MCAFV in healthy pregnancy compared with non-pregnant women and a small, but non-significant, increase in mean MCAFV in the hypertensive and pre-eclamptic women. Demarin and colleagues studied pre-eclamptic women before and after delivery and found a progressive increase in MCAFV during late pregnancy. Ohno and colleagues compared MCAFV in 35 healthy pregnant and 17 pre-eclamptic women. In this study, the mean MCAFV was significantly higher in the pre-eclamptic group. It has been suggested that these increases in MCAFV are because of a degree of vasospasm. The differences between the findings of various studies with regards to the changes in MCAFV in pre-eclampsia might be explained by the differences in the severity of pre-eclampsia between the studies. Some investigators have reported increased MCAFV in symptomatic, compared with asymptomatic pre-eclamptics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| labetalol in the managment of severe preeclampsia | Active comparator | Drug: Labetalollabetalol intravenous infusion (Trandate, Gsk) in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication is 5 ml/hr for an 80 Kg patient |
| phentolamine in the managment of severe preeclampsia | Active comparator | Drug: Phentolaminephentolamine intravenous infusion (Rogitamine) in a concentration of 10 mg/ml, thus 1 µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Pregnant woman with severe preeclampsia diagnosed by obstetric doctor
Key exclusion criteria (7 listed)
- • Patients with eminent eclampsia
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 |
|---|---|---|
| LabetalolAlso: trandate, GskGroup L will recieve labetalol intravenous infusion (Trandate, Gsk) in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication is 5 ml/hr for an 80 Kg patient. | Drug | labetalol in the managment of severe preeclampsia |
| PhentolamineAlso: RogitamineGroup P will receive phentolamine intravenous infusion (Rogitamine) in a concentration of 10 mg/ml, thus 1 µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient. | Drug | phentolamine in the managment of severe preeclampsia |
Primary outcome
the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring.
Time frame: 6 hours
Singleton pregnant women who suffered from late onset preeclampsia will be enrolled and subjected to baseline Transcranial doppler (TCD) evaluation to measure middle cerebral artery (MCA) blood flow indices including mean flow velocity (cm/s).
1 secondary outcome
The effect of labetalol and phentolamine on blood pressure of the patients
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Labetalol and Phentolamine in people with Severe Pre-eclampsia, run by Assiut University.
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 7 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring. (time frame: 6 hours). 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 26 Apr 2024.