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

Not Applicable

Withdrawn

• Conditions: Tocolysis With Nifedipine
• Interventions: Other: Nifedipine for tocolysis

• Registration Number: NCT02902354
• Lead Sponsor: St. Louis University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nifedipine for tocolysis	Nifedipine for tocolysis	Only women receiving nifedipine (as standard of care) for tocolysis

Primary Outcome Measures

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