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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02902354
Enrollment
0
Registered
2016-09-15
Start date
2016-09-30
Completion date
2017-01-31
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tocolysis With Nifedipine

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.

Interventions

OTHERNifedipine for tocolysis

observational

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.every 20 min for 3 hoursTo determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026