Clinical trial NCT03325348: Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia
Official title: Oral Nifedipine Versus IV Labetalol in Treatment of Severe Pre Eclampsia in Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Severe Pre-Eclampsia, Antepartum
Keywords: Severe Pre eclampsia
Nifidepine
Labetalol
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2017-10-30
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Time taken for Blood Pressure control
timeFrame: 60 minutes
Secondary outcomes:
measure: Fetal distress
timeFrame: Labour
measure: Neonatal Intensive Care Unit admission,
timeFrame: From Birth till 7 days
measure: perinatal death
timeFrame: From birth to 7 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences
state: Punjab
Study officials:
References: