Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

NCT03325348 | Unknown Phase 2 DMC

• 1 other identifier: IRB/2017/306/SIMS
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Pre-Eclampsia, Antepartum

Keywords

Severe Pre eclampsia; Nifidepine; Labetalol

Outcome Measures

Primary Outcomes (1)

• Time taken for Blood Pressure control

  Time taken to control Blood pressure will be measured

  60 minutes

Secondary Outcomes (3)

• Fetal distress

  Labour

• Neonatal Intensive Care Unit admission,

  From Birth till 7 days

• perinatal death

  From birth to 7 days

Study Arms (2)

Oral Nifedipine

EXPERIMENTAL

Nifedipine 10mg oral tablet \& 1ml 0.9%N/Saline will be given every 15 minutes up till one hour

Drug: Nifedipine 10 mg

IV Labetalol

ACTIVE COMPARATOR

IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour

Drug: Labetalol

Interventions

Nifedipine 10 mg DRUG

Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour

Also known as: Cap nefidil 10 mg

Oral Nifedipine

Labetalol DRUG

IV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour

Also known as: Labetalol Hydrochloride injection

IV Labetalol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age 24 to 41 weeks
• BP \> 160/110 mm Hg with proteinuria
• Patients with S/S of imminent eclampsia as headache, visual disturbance.

You may not qualify if:

• Gestational age \< 24 wks
• Non proteinuric chronic hypertension
• Eclampsia
• Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Nifedipine; Labetalol

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Central Study Contacts

Tayyiba Wasim, FCPS

CONTACT

+923008400197; tayyibawasim@yahoo.com

Natasha Usman

CONTACT

+923008480027; natashausman5@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor obs Gynecology

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 30, 2017
• Study Start: February 23, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 15, 2018
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

PA (1)