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NCT05310929

Nitroglycerin Versus Labetalol in Acute Severe Pre-eclampsia

Completed NA Last updated 5 April 2022
What this trial tests

NA trial testing Labetalol and Glyceril trinitrate in Severe Pre-eclampsia in 200 participants. Completed in 25 March 2022.

Timeline
28 August 2019
Primary endpoint
20 March 2022
25 March 2022

Quick facts

Lead sponsorAin Shams University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment200
Start date28 August 2019
Primary completion20 March 2022
Estimated completion25 March 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 18 to 40, female only, with Severe Pre-eclampsia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacotherapeutic options for the treatment of hypertension in pregnancy.
    Conti-Ramsden F, de Marvao A, Chappell LC. · · 2024 · cited 4× · PMID 39225514 · DOI 10.1080/14656566.2024.2398602

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