PregnancyNCT00782730
Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum
An observational study of Pregnancy, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age greater than 18 years.
- Having a non-emergent Cesarean Delivery or labor epidural placed.
Who cannot join
- Age less than 18 years.
- Emergent Cesarean delivery.
- No epidural labor analgesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
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
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.
- Conditions
- Pregnancy
- Keywords
- bladder volume measurement, pregnancy, bladder function, Postvoid residual volume assessment, Bladder volumes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Define normal post-void residual volume in third trimester pregnancy and post-partum.
Measured: 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.
Measured: 12-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stitely, West Virginia University
- Investigators
- Michael L Stitely, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782730
- Sponsor's protocol ID
- H-20862
- Status last verified
- Jun 2013
- First submitted
- 29 Oct 2008
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00782730
- Acronym / sponsor ID
- H-20862
- Conditions
- Pregnancy
- Keywords
- bladder volume measurement, pregnancy, bladder function, Postvoid residual volume assessment, Bladder volumes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age greater than 18 years.
- Having a non-emergent Cesarean Delivery or labor epidural placed.
Key exclusion criteria (3 listed)
- Age less than 18 years.
- Emergent Cesarean delivery.
- No epidural labor analgesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define normal post-void residual volume in third trimester pregnancy and post-partum.
Time frame: 12-24 hours
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Stitely, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define normal post-void residual volume in third trimester pregnancy and post-partum. (time frame: 12-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.