Status:
COMPLETED
Nitroglycerin Versus Labetalol in Acute Severe Pre-eclampsia
Lead Sponsor:
Ain Shams University
Conditions:
Severe Pre-eclampsia
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Two hundred patients with severe PE were admitted prepartum to the ICU to stabilize blood pressure. They were randomly assigned to one of two groups (100 in each group): Group N received nitroglycerin...
Detailed Description
Patients and Methods The study was conducted in the intensive care unit (ICU) of the Obstetrics and Gynaecology Hospital of Ain-Shams University as a randomized, double-blind, and placebo-controlled s...
Eligibility Criteria
Inclusion
- Woman eligible for this study were aged between 18-40 years old at greater than 34 weeks of gestation having severe PE without severe features (without imminence of eclampsia or clinical manifestations of target organ damage, as per the ACOG criteria) (7). Severe PE was diagnosed by severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg, repeated measurement should be taken for confirmation no more than 15 minutes later), presence of clinically significant proteinuria (0.3 grams or more of protein in 24-hour urine collection, or urinary protein/creatinine ratio of 30 or more) -
Exclusion
- patients with chronic hypertension, imminence of eclampsia, target organ damage, active asthma and congestive heart failure. Patients with any known allergy to one of the study drugs are also excluded.
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Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05310929
Start Date
August 28 2019
End Date
March 25 2022
Last Update
April 5 2022
Active Locations (1)
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1
AinShams university hospitals
Cairo, Egypt