Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

October 24, 2017 updated by: Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

194

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Labetalol Hydrochloride injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal distress
Time Frame: Labour

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,
Time Frame: From Birth till 7 days
If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours
From Birth till 7 days
perinatal death
Time Frame: From birth to 7 days
If death of baby occurs in utero or within 7 days of delivery
From birth to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 15, 2018

Study Registration Dates

First Submitted

September 30, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2017/306/SIMS

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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