Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia | NCT03325348

Studies
Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

NCT03325348

Sponsor

Services Institute of Medical Sciences, Pakistan

Status

Unknown status

Last Update Posted

Oct 30, 2017Actual

Enrollment

194Estimated

Phase

Phase 2Phase 3

Conditions

Severe Pre-Eclampsia, Antepartum

Interventions

Nifedipine 10 mg
Labetalol

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2017Actual

Primary Completion Date

Dec 2017Estimated

Completion Date

Jan 15, 2018Estimated

First Submitted Date

Sep 30, 2017

First Submission Date that Met QC Criteria

Oct 24, 2017

First Posted Date

Oct 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2017

Last Update Posted Date

Oct 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tayyiba Wasim, professor obs Gynecology, Services Institute of Medical Sciences, PakistanPrincipal Investigator

Lead Sponsor

Services Institute of Medical Sciences, PakistanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

194Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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	Oral Nifedipine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Fetal distress	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,	If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tayyiba Wasim, FCPS	Contact	+923008400197		tayyibawasim@yahoo.com
Natasha Usman	Contact	+923008480027		natashausman5@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Services Institute of Medical Sciences	Recruiting	Lahore	Punjab Province		Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009543	Nifedipine
D007741	Labetalol

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided