Clinical trial

A Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine to Control Blood Pressure in Severe Pre-eclampsia

Name

Soh-Med-24-01-07MS

Description

Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE

Trial arms

Trial start

2024-03-30

Estimated PCD

2025-03-30

Trial end

2025-03-30

Status

Not yet recruiting

Treatment

Labetalol

it contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent

Arms:

group A

Nitroglycerine

a nitric oxide donor with low oral bioavailability and a very short half-life, has a potent venodilator effect in low doses and affects arterial tone at high doses

Arms:

group B

Nifedipine

dihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive

Arms:

group C

Size

Primary endpoint

duration of control blood pressure

1 year

Eligibility criteria

Inclusion Criteria: * The study will include 60 adult female patients ( 18 to 40 years old) with sever pre-eclampsia, who were being managed with MgSO4 loading and maintenance doses Severe hypertension was diagnosed by Systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥110 mmHg. Mean arterial blood pressure ≥ 127 mmHg Exclusion Criteria: 1. Patient refusal. 2. Eclampsia 3. Emenant eclampsia 4. HELLP syndrome 5. Chronic hypertension 6. Patients who have chronic obstructive pulmonary disease. 7. Patient with acute or chronic liver failure. 8. Known allergy to the study medications

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-02-20

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product