NCT00782730

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

October 29, 2008

Last Update Submit

June 11, 2013

Conditions

Pregnancy

Keywords

bladder volume measurementpregnancybladder functionPostvoid residual volume assessmentBladder volumes

Outcome Measures

Primary Outcomes (1)

  • Define normal post-void residual volume in third trimester pregnancy and post-partum.

    12-24 hours

Secondary Outcomes (1)

  • Calculate the validity of measurements form the bladder scanner ultrasound for bladder volumes during the third trimester of pregnancy and post-partum.

    12-24 hours

Study Arms (1)

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 Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Study Officials

  • Michael L Stitely, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

US(1)