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

NCT ID: NCT02902354

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-01-31

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.

Conditions

Tocolysis With Nifedipine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Nifedipine for tocolysis

Only women receiving nifedipine (as standard of care) for tocolysis

Group Type: OTHER

Nifedipine for tocolysis

Intervention Type: OTHER

observational

Interventions

Nifedipine for tocolysis

observational

Intervention Type: OTHER

Other Intervention Names

Standard of care

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Goldkamp, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Goldkamp, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Other Identifiers

27468

Identifier Type: -

Identifier Source: org_study_id