Changes in Central Arterial Pressure When Comparing Nifed... | NCT02912910

Studies
Changes in Central Arterial Pressure When Comparing Nifedipine/Labetalol for Routine Hypertension Control in Pregnancy

NCT02912910

Sponsor

St. Louis University

Status

Withdrawn

Last Update Posted

Nov 13, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Nifedipine
Labetalol

Countries

Not provided

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI withdrew protocol

Expanded Access Info

Start Date

Sep 2016Estimated

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Sep 21, 2016

First Posted Date

Sep 23, 2016Estimated

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

Nov 8, 2017

Last Update Posted Date

Nov 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.

Detailed Description

Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.

Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.

Their participation will be complete after the 4 hour assessment is complete.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nifedipine		patients will be assigned to antihypertensive medications by their physicians in the course of their routine care	Other: Nifedipine
Labetalol		patients will be assigned to antihypertensive medications by their physicians in the course of their routine care	Other: Labetalol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine	Other	patients will be assigned to antihypertensive medications by their physicians in the course of their routine care	Nifedipine

Measure	Description	Time Frame
central blood pressure changes		every 30 min for 4 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy
Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol

Exclusion Criteria:

Multiple pregnancy
Currently on multiple anti-hypertension medications
Narcotic use
Irregular heart rhythms or arrhythmias
Peripheral arterial disease, leg artery disease
Reynaud's phenomena
Intense cold/hypothermia
If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
Known sensitivity to labetalol or nifedipine
Severe tachycardia (>120)
Greater than 1st degree heart block
Severe asthma
Congestive heart failure or heart disease
Lupus
Inability to adequately monitor BP
Currently receiving magnesium sulfate

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.

Sampling Method

Probability Sample

Name	Affiliation	Role
Jennifer Goldkamp	St. Louis University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular 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