Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine

NCT ID: NCT06265415

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-30
• Study Completion Date: 2025-03-30

Brief Summary

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

Detailed 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.

Pre-eclampsia characterized by

• Rising blood pressure (BP ≥ 140/90 that occurs after 20 weeks of gestation in a woman with previously normal BP.
• . Proteinuria (≥300mg/24hr . This correlates with 30mg/dl or ≥1+ on urine dipstick)
• Edema control of blood pressure is of crucial importance to avoid maternal and fetal complications.

The pathophysiology of pre-eclampsia is most likely inadequate placentation, leading to endothelial dysfunction and reduced nitric oxide bioavailability. 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

. 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 Labetalol is useful as it contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent Nifedipine is a dihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive

Conditions

Severe Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

(20 patients) will receive Labetalol intravenous infusion. The starting infusion rate is 5mg/h,the infusion rate will be changed 1mg/h up every 10 minutes until the desired goal achieved which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg every 10 minutes

Group Type: ACTIVE_COMPARATOR

Labetalol

Intervention Type: DRUG

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

group B

(20 patients) will receive calculated dose of Nitroglycerine started as intravenous infusion, The starting infusion rate is 4.8mg/h ,the infusion rate will be changed 1mg/h every 10 minutes up until the therapeutic goal achieved, which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg

Group Type: ACTIVE_COMPARATOR

Nitroglycerine

Intervention Type: DRUG

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

group C

, (20 patients) will receive calculated dose of nifedipine the content (100 µL) of a 10 mg capsule of nifedipine was drawn up into an insulin syringe and deposited sublingually, every 30 min.( Maximum dose of nifedipine 120 mg/day) ) until the therapeutic goal achieved, which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg

Group Type: ACTIVE_COMPARATOR

Nifedipine

Intervention Type: DRUG

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

Interventions

Labetalol

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Nifedipine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Diaa Aly Abdelaal

Resident-anesthesia,surgical intensive care and pain control department-sohag hospital university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

diaa A abdelaal, resident

Role: CONTACT

deaaaly@med.sohag.edu.eg

01064451169

fawzy A badawy, assistant professor

Role: CONTACT

01004862474

References

Al-Mulhim AA, Abu-Heija A, Al-Jamma F, El-Harith el-HA. Pre-eclampsia: maternal risk factors and perinatal outcome. Fetal Diagn Ther. 2003 Jul-Aug;18(4):275-80. doi: 10.1159/000070809.

Reference Type: BACKGROUND

PMID: 12835589 (View on PubMed)

Olayinka L, Garnett E, Burnett B, Devaraj S. Comparison of random urine protein/creatinine ratio with 24-hour urine protein in suspected pre-eclampsia. Pract Lab Med. 2023 Jun 21;36:e00316. doi: 10.1016/j.plabm.2023.e00316. eCollection 2023 Aug.

Reference Type: BACKGROUND

PMID: 37649542 (View on PubMed)

Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.

Reference Type: BACKGROUND

PMID: 24313856 (View on PubMed)

Divakaran S, Loscalzo J. The Role of Nitroglycerin and Other Nitrogen Oxides in Cardiovascular Therapeutics. J Am Coll Cardiol. 2017 Nov 7;70(19):2393-2410. doi: 10.1016/j.jacc.2017.09.1064.

Reference Type: BACKGROUND

PMID: 29096811 (View on PubMed)

Other Identifiers

Soh-Med-24-01-07MS

Identifier Type: -

Identifier Source: org_study_id