Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Pre-eclampsia
• Intervention / Treatment: Drug: Labetalol; Drug: Phentolamine

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Pregnant woman with severe preeclampsia diagnosed by obstetric doctor

  • Patients willing to participate in the study
  • Age above 18 yrs

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: labetalol in the managment of severe preeclampsia; 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; 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.; Other Names: trandate, Gsk
Active Comparator: phentolamine in the managment of severe preeclampsia; 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; 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.; Other Names: Rogitamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of labetalol and phentolamine on blood pressure of the patients	through measuring the blood pressure in (mmHg)	6 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2024
• Primary Completion (Estimated): January 20, 2026
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Labetalol; Phentolamine
• Other Study ID Numbers: severe preeclampsia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No