- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02902354
Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Nifedipine for tocolysis
Only women receiving nifedipine (as standard of care) for tocolysis
|
observational
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
every 20 min for 3 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27468
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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