Changes in Central Arterial Pressure of Normotensive Wome... | NCT02902354

Studies
Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis

NCT02902354

Sponsor

St. Louis University

Status

Withdrawn

Last Update Posted

Nov 13, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Tocolysis With Nifedipine

Interventions

Nifedipine for tocolysis

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Withdrawn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

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 15, 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 determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression

Detailed Description

Only women whom have been prescribed nifedipine tocolysis by their covering obstetrician will be approached to participate in the study.

The patient will take their nifedipine as scheduled, we will attain central arterial pressure reading in addition to arterial waveform measurements. These will be collected:

Before administration of the medication Every 20 minutes for 3 hours (total of 10 measurements)

-This timing will allow measurements through approximately 2 half lives Routine sphygmomanometry will also be completed at the testing times All of these measurements will be collected for study purposes, although the nurses will have the opportunity to record the routine blood pressure measurements for their charting/vital signs assessment if they desire.

Once the patient has been monitored for 3 hours, her participation in the study is considered complete and no additional information will be collected. Each patient will serve as her own control (blood pressure prior to administration of medication), no randomization will occur.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nifedipine for tocolysis	Other	Only women receiving nifedipine (as standard of care) for tocolysis	Other: Nifedipine for tocolysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine for tocolysis	Other	observational	Nifedipine for tocolysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.	To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.	every 20 min for 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy
Currently receiving tocolysis with nifedipine (10 or 20mg q4-6 hours)

Exclusion Criteria:

Multiple pregnancy
Diagnosis of hypertensive disorder in pregnancy or blood pressures 140/90 or higher on -more than 2 occasions.
Currently on antihypertensive medications (Nifedipine XL, labetalol, hydralazine, methyl-dopa, etc)
Currently on other tocolytic medications (exp: magnesium, Indocin)
Narcotic use
Renal diseaseI
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
Severe tachycardia (>120)
Greater than 1st degree heart block
Severe asthma
Congestive heart failure or heart disease
Lupus, rheumatoid arthritis
Inability to adequately monitor BP
Magnesium treatment

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jennifer Goldkamp, MD	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

Intervention Browse Module

MeSH Terms

ID	Term
D009543	Nifedipine
D015145	Tocolysis
D059039	Standard of Care

Ancestor Terms

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

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