Back to results

Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Primary Purpose

Severe Pre-Eclampsia, Antepartum

Status

Unknown status

Phase

Phase 2

Locations

Pakistan

Study Type

Interventional

Intervention

Nifedipine 10 mg

Labetalol

About this trial

This is an interventional treatment trial for Severe Pre-Eclampsia, Antepartum focused on measuring Severe Pre eclampsia, Nifidepine, Labetalol

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Services Institute of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Nifedipine

IV Labetalol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time taken for Blood Pressure control

Time taken to control Blood pressure will be measured

Secondary Outcome Measures

Fetal distress

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

Neonatal Intensive Care Unit admission,

If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours

perinatal death

If death of baby occurs in utero or within 7 days of delivery

Full Information

NCT ID

NCT03325348

First Posted

September 30, 2017

Last Updated

October 24, 2017

Sponsor

Services Institute of Medical Sciences, Pakistan

1. Study Identification

Unique Protocol Identification Number

NCT03325348

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 23, 2017 (Actual)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

January 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Services Institute of Medical Sciences, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Pre-Eclampsia, Antepartum

Keywords

Severe Pre eclampsia, Nifidepine, Labetalol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Nifedipine

Arm Type

Experimental

Arm Description

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

Arm Title

IV Labetalol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nifedipine 10 mg

Other Intervention Name(s)

Cap nefidil 10 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Labetalol

Other Intervention Name(s)

Labetalol Hydrochloride injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Time taken for Blood Pressure control

Description

Time taken to control Blood pressure will be measured

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Fetal distress

Description

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

Time Frame

Labour

Title

Neonatal Intensive Care Unit admission,

Description

If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours

Time Frame

From Birth till 7 days

Title

perinatal death

Description

If death of baby occurs in utero or within 7 days of delivery

Time Frame

From birth to 7 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tayyiba Wasim, FCPS

Phone

+923008400197

tayyibawasim@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Natasha Usman

Phone

+923008480027

natashausman5@hotmail.com

Facility Information:

Facility Name

Services Institute of Medical Sciences

City

Lahore

State/Province

Punjab

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

TAYYIBA WASIM, FCPS

Phone

+923008400197

tayyibawasim@yahoo.com

First Name & Middle Initial & Last Name & Degree

Natasha Usman, FCPS

natashausman5@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

We'll reach out to this number within 24 hrs