Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum
This study has been completed.
Sponsor:
West Virginia University
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 29, 2008 | ||||
| Last Updated Date | June 11, 2013 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Define normal post-void residual volume in third trimester pregnancy and post-partum. [ Time Frame: 12-24 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00782730 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum | ||||
| Official Title ICMJE | Assessment of Third Trimester Post-void Residual Along With Determining Validity of the Bladder Scanner in the Third Trimester of Pregnancy and Postpartum | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 35 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00782730 | ||||
| Other Study ID Numbers ICMJE | H-20862 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michael Stitely, West Virginia University | ||||
| Study Sponsor ICMJE | West Virginia University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | West Virginia University | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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