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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
194
Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour
IV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour
Services Institute of Medical Sciences
Lahore, Punjab Province, Pakistan
RECRUITINGTime taken for Blood Pressure control
Time taken to control Blood pressure will be measured
Time frame: 60 minutes
Fetal distress
Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium. of Meconium
Time frame: Labour
Neonatal Intensive Care Unit admission,
If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours
Time frame: From Birth till 7 days
perinatal death
If death of baby occurs in utero or within 7 days of delivery
Time frame: From birth to 7 days
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