Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum

June 11, 2013 updated by: Michael Stitely, West Virginia University

Assessment of Third Trimester Post-void Residual Along With Determining Validity of the Bladder Scanner in the Third Trimester of Pregnancy and Postpartum

This will be a descriptive study measuring the post-void residual of patients in the third trimester and postpartum. Also, bladder scan values will be compared to the amount of urine obtained from a Foley catheter to determine the accuracy of the bladder scanner in the third trimester and postpartum.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All adult patients undergoing elective or non-emergent Cesarean delivery will be asked to enroll. Also adult patients having a labor epidural placed during labor will be asked to participate.

Description

Inclusion Criteria:

  • Age greater than 18 years.
  • Having a non-emergent Cesarean Delivery or labor epidural placed.

Exclusion Criteria:

  • Age less than 18 years.
  • Emergent Cesarean delivery.
  • No epidural labor analgesia.

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

Cohorts and Interventions

Group / Cohort
Bladder Scan Group
Patients who agree to enroll in the trial and allow their known bladder volumes and residual bladder volumes to be measured by actual volumes retrograde instilled, and also by bladder scanner ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Define normal post-void residual volume in third trimester pregnancy and post-partum.
Time Frame: 12-24 hours
12-24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Calculate the validity of measurements form the bladder scanner ultrasound for bladder volumes during the third trimester of pregnancy and post-partum.
Time Frame: 12-24 hours
12-24 hours

Collaborators and Investigators

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

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Michael L Stitely, MD, West Virginia 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

October 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-20862

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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