Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.

NCT06385600 | Not Yet Recruiting

• 1 other identifier: severe preeclampsia
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Severe Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• 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).

  6 hours

Secondary Outcomes (1)

• The effect of labetalol and phentolamine on blood pressure of the patients

  6 hours

Study Arms (2)

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

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

Drug: Phentolamine

Interventions

Labetalol DRUG

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.

Also known as: trandate, Gsk

labetalol in the managment of severe preeclampsia

Phentolamine DRUG

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.

Also known as: Rogitamine

phentolamine in the managment of severe preeclampsia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman with severe preeclampsia diagnosed by obstetric doctor
• Patients willing to participate in the study
• Age above 18 yrs

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Labetalol; halofantrine; Phentolamine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: April 26, 2024
• Study Start: May 20, 2024
• Primary Completion: January 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04