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

Saint Louis University (SLU)

Status: Withdrawn

Conditions: Tocolysis With Nifedipine

Treatments: Other: Nifedipine for tocolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02902354

27468

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Nifedipine for tocolysis

Other group

Description:

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

Treatment:

Other: Nifedipine for tocolysis