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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

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.

Interventions

  • Other: Nifedipine for tocolysis
    • observational

Arms, Groups and Cohorts

  • Other: Nifedipine for tocolysis
    • Only women receiving nifedipine (as standard of care) for tocolysis

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 14 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Louis University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer Goldkamp, MD, MD – St. Louis University
  • Overall Official(s)
    • Jennifer Goldkamp, MD, Principal Investigator, St. Louis University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.