Assessment of Third Trimester Post-Void Residual and Validation of Bladder Scanner in Pregnancy and Post-Partum

This study is currently recruiting participants.

Verified by West Virginia University, November 2008

First Received: October 29, 2008 Last Updated: November 6, 2008 History of Changes

Sponsored by:	West Virginia University
Information provided by:	West Virginia University
ClinicalTrials.gov Identifier:	NCT00782730

Purpose

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.

Condition
Pregnancy

MedlinePlus related topics: Postpartum Care

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Assessment of Third Trimester Post-Void Residual Along With Determining Validity of the Bladder Scanner in the Third Trimester of Pregnancy and Postpartum

Further study details as provided by West Virginia University:

Primary Outcome Measures:

Define normal post-void residual volume in third trimester pregnancy and post-partum. [ Time Frame: 12-24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782730

Contacts

Contact: Michael L Stitely, MD	304-293-1566	MStitely@hsc.wvu.edu
Contact: Shon P Rowan, MD	304-598-4878	SRowan@hsc.wvu.edu

Locations

United States, West Virginia
West Virginia University	Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Michael L Stitely, MD 304-293-1566 MStitely@hsc.wvu.edu
Contact: Shon P Rowan, MD 304-598-4878 SRowan@hsc.wvu.edu
Principal Investigator: Michael L Stitely, MD
Sub-Investigator: Shon P Rowan, MD

Sponsors and Collaborators

West Virginia University

Investigators

Principal Investigator:

Michael L Stitely, MD

West Virginia University

More Information

No publications provided

Responsible Party:	West Virginia University ( Michael L. Stitely, MD )
Study ID Numbers:	H-20862
Study First Received:	October 29, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00782730 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by West Virginia University:

bladder volume measurement
pregnancy
bladder function
Postvoid residual volume assessment
Bladder volumes

ClinicalTrials.gov processed this record on May 07, 2009