Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Severe Pre-Eclampsia, Antepartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03325348
• Other study ID #: IRB/2017/306/SIMS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 30, 2017
• Last updated: October 24, 2017
• Start date: February 23, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: October 2017
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: Tayyiba Wasim, FCPS
• Phone: +923008400197
• Email: tayyibawasim[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: January 15, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Obstetric Labor Complications
• Pre-Eclampsia
• Severe Pre-Eclampsia, Antepartum

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Pakistan	Services Institute of Medical Sciences	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time taken for Blood Pressure control	Time taken to control Blood pressure will be measured	60 minutes
Secondary	Fetal distress	Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium.; of Meconium	Labour
Secondary	Neonatal Intensive Care Unit admission,	If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours	From Birth till 7 days
Secondary	perinatal death	If death of baby occurs in utero or within 7 days of delivery	From birth to 7 days