Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

• Status: Unknown status
• Trial end date: 2018-01-15
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Services Institute of Medical Sciences, Pakistan
• Treatments: Labetalol; Nifedipine

Criteria

Inclusion Criteria:

• Gestational age 24 to 41 weeks

• BP > 160/110 mm Hg with proteinuria

• Patients with S/S of imminent eclampsia as headache, visual disturbance.

Exclusion Criteria:

• Gestational age < 24 wks

• Non proteinuric chronic hypertension

• Eclampsia

• Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol