Severe Pre-Eclampsia, Antepartum
Conditions
Keywords
Severe Pre eclampsia, Nifidepine, Labetalol
Brief 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
Interventions
DRUGNifedipine 10 mg
Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour
DRUGLabetalol
IV labetalol 20 mg & mint tablet will be given to patients every 15 min until one hour
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time taken for Blood Pressure control | 60 minutes | Time taken to control Blood pressure will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal distress | Labour | Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium. of Meconium |
| Neonatal Intensive Care Unit admission, | From Birth till 7 days | If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours |
| perinatal death | From birth to 7 days | If death of baby occurs in utero or within 7 days of delivery |
Countries
Pakistan
Contacts
Primary ContactTayyiba Wasim, FCPS
Backup ContactNatasha Usman
Outcome results
None listed