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Trial record 2 of 144 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT02902354
Recruitment Status : Withdrawn
First Posted : September 15, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Goldkamp, MD, St. Louis University

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

Condition or disease Intervention/treatment Phase
Tocolysis With Nifedipine Other: Nifedipine for tocolysis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis
Study Start Date : September 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arm Intervention/treatment
Nifedipine for tocolysis
Only women receiving nifedipine (as standard of care) for tocolysis
Other: Nifedipine for tocolysis
observational
Other Name: Standard of care




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902354


Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Jennifer Goldkamp, MD St. Louis University

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Responsible Party: Jennifer Goldkamp, MD, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02902354     History of Changes
Other Study ID Numbers: 27468
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents