Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Study Overview
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Brief Summary
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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 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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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

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

Conditions
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Severe Pre-Eclampsia, Antepartum

Intervention / Treatment
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* Drug: Nifedipine 10 mg
* Drug: Labetalol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Nifedipine<br>Nifedipine 10mg oral tablet & 1ml 0.9%N/Saline will be given every 15 minutes up till one hour | Drug: Nifedipine 10 mg<br>* Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour<br>* Other names: Cap nefidil 10 mg;|
| Active Comparator: IV Labetalol<br>IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour | Drug: Labetalol<br>* IV labetalol 20 mg & mint tablet will be given to patients every 15 min until one hour<br>* Other names: Labetalol Hydrochloride injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken for Blood Pressure control | Time taken to control Blood pressure will be measured | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal distress | Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium. of Meconium | Labour | 
| Neonatal Intensive Care Unit admission, | If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours | From Birth till 7 days | 
| perinatal death | If death of baby occurs in utero or within 7 days of delivery | From birth to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Pre eclampsia, Nifidepine, Labetalol