NCT03325348

Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Oral Nifedipine Versus IV Labetalol in Treatment of Severe Pre Eclampsia in Pregnancy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Services Institute of Medical Sciences, Pakistan · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

Gestational hypertension is associated with increased risk of maternal morbidity and mortality. Parenteral therapy needs more resources, more monitoring and supervision. Oral therapy is cheap, easily available, easy to administer especially in resource constrained settings 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 mm Hg 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

Conditions

• Severe Pre-Eclampsia, Antepartum

Interventions

Type	Name	Description
DRUG	Nifedipine 10 mg	Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour
DRUG	Labetalol	IV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour

Timeline

• Start date: 2017-02-23
• Primary completion: 2017-12-01
• Completion: 2018-01-15
• First posted: 2017-10-30
• Last updated: 2017-10-30

Locations

1 site across 1 country: Pakistan