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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Stitely, West Virginia University
ClinicalTrials.gov Identifier:
NCT00782730
First received: October 29, 2008
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 35
Study Start Date: October 2008
Primary Completion Date: December 2009 (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

Locations
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Michael L Stitely, MD West Virginia University
  More Information

No publications provided

Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00782730     History of Changes
Other Study ID Numbers: H-20862
Study First Received: October 29, 2008
Last Updated: June 11, 2013
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 June 13, 2013