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Nitroglycerin Versus Labetalol in Acute Severe Pre-eclampsia

NCT05310929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-05

No results posted yet for this study

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 nitroglycerine intravenous infusion in a concentration of 1 mg/ml, thus 1µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient. Group L received labetalol intravenous infusion in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication was 5 ml/hr. The infusion rate was titrated to stabilize systolic blood pressure (SBP) at 130-140 mmHg and diastolic blood pressure (DBP) at 80-90 mmHg (study end point) by adjusting the infusion rate as required either by maintaining the same infusion rate or by changing its infusion rate by 1 ml/hr up or down according to the clinical condition every 10 minutes. On any abrupt reduction in blood pressure below 120 mmHg for SBP or 80 mmHg for DBP, the infusion was immediately discontinued, and a bolus of 150 ml lactate ringer was given.

Conditions

  • Severe Pre-eclampsia

Interventions

DRUG

Labetalol and Glyceril trinitrate

for control of blood pressure

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Fathy Tash, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2022-03-20
Completion
2022-03-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05310929 on ClinicalTrials.gov