Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine

Not Applicable

Not yet recruiting

• Conditions: Severe Preeclampsia
• Interventions: Drug: Nitroglycerine; Drug: Labetalol; Drug: Nifedipine

• Registration Number: NCT06265415
• Lead Sponsor: Sohag University

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

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-11
• Study First Submitted QC: 2024-02-11
• Last Update Submitted: 2024-02-11
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-03-30
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Nitroglycerine	(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 A	Labetalol	(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 C	Nifedipine	, (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

Primary Outcome Measures

Name	Time	Method
duration of control blood pressure	1 year	duration required, of nitroglycerin compared to labetalol and sublingual nifedipine in terms of acute control of blood pressure in severe PE.