Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia
NCT ID: NCT03325348
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
194 participants
INTERVENTIONAL
2017-02-23
2018-01-15
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oral Nifedipine
Nifedipine 10mg oral tablet \& 1ml 0.9%N/Saline will be given every 15 minutes up till one hour
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
IV Labetalol
IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour
Labetalol
IV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour
Interventions
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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
Labetalol
IV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BP \> 160/110 mm Hg with proteinuria
* Patients with S/S of imminent eclampsia as headache, visual disturbance.
Exclusion Criteria
* Non proteinuric chronic hypertension
* Eclampsia
* Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol
18 Years
40 Years
FEMALE
Yes
Sponsors
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Services Institute of Medical Sciences, Pakistan
OTHER_GOV
Responsible Party
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Tayyiba Wasim
professor obs Gynecology
Locations
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Services Institute of Medical Sciences
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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TAYYIBA WASIM, FCPS
Role: primary
Natasha Usman, FCPS
Role: backup
Other Identifiers
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IRB/2017/306/SIMS
Identifier Type: -
Identifier Source: org_study_id