drugset / Trial / NCT03325348

Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

NCT03325348

Phase 2/3 Unknown 194 enrolled Services Institute of Medical Sciences, Pakistan
RandomizedParallel-groupSingle-blindTreatment

Summary

OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients Design: Randomised control trial SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences. Lahore POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful

Timeline

Start
2017-02-23
Primary completion
2017-12
Completion
2018-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Labetalol Small molecule 80 mg Intravenous
Subject Nifedipine Other / unclassified 10 mg Oral

Indications