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Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

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ClinicalTrials.gov Identifier: NCT03325348
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan

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


Condition or disease Intervention/treatment Phase
Severe Pre-Eclampsia, Antepartum Drug: Nifedipine 10 mg Drug: Labetalol Phase 2 Phase 3

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Oral Nifedipine Versus IV Labetalol in Treatment of Severe Pre Eclampsia in Pregnancy
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 15, 2018


Arm Intervention/treatment
Experimental: Oral Nifedipine
Nifedipine 10mg oral tablet & 1ml 0.9%N/Saline will be given every 15 minutes up till one hour
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
Other Name: Cap nefidil 10 mg

Active Comparator: IV Labetalol
IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour
Drug: Labetalol
IV labetalol 20 mg & mint tablet will be given to patients every 15 min until one hour
Other Name: Labetalol Hydrochloride injection




Primary Outcome Measures :
  1. Time taken for Blood Pressure control [ Time Frame: 60 minutes ]
    Time taken to control Blood pressure will be measured


Secondary Outcome Measures :
  1. Fetal distress [ Time Frame: Labour ]

    Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium.

    of Meconium


  2. Neonatal Intensive Care Unit admission, [ Time Frame: From Birth till 7 days ]
    If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours

  3. perinatal death [ Time Frame: From birth to 7 days ]
    If death of baby occurs in utero or within 7 days of delivery



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325348


Contacts
Contact: Tayyiba Wasim, FCPS +923008400197 tayyibawasim@yahoo.com
Contact: Natasha Usman +923008480027 natashausman5@hotmail.com

Locations
Pakistan
Services Institute of Medical Sciences Recruiting
Lahore, Punjab, Pakistan
Contact: TAYYIBA WASIM, FCPS    +923008400197    tayyibawasim@yahoo.com   
Contact: Natasha Usman, FCPS       natashausman5@hotmail.com   
Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan

Responsible Party: Tayyiba Wasim, professor obs Gynecology, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT03325348     History of Changes
Other Study ID Numbers: IRB/2017/306/SIMS
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan:
Severe Pre eclampsia
Nifidepine
Labetalol

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Eclampsia
Pre-Eclampsia
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Labetalol
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists