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

November 8, 2017 updated by: Jennifer Goldkamp, MD, St. Louis University
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression

Study Overview

Status

Withdrawn

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

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Nifedipine for tocolysis
observational
Other Names:
  • Standard of care

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

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

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)?

No

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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