Clinical trial NCT06265415: Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine
Official title: A Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine to Control Blood Pressure in Severe Pre-eclampsia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Preeclampsia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: duration of control blood pressure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.