Postpartum WomenRPM-EvalNCT02597413
Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study
An observational study of Postpartum Women, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Women
- What is being tested?
- Catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2015
- 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: The study population is all paturient women admitted to delivery rooms.
Who may be able to join
- Paturient women admitted to the delivery room
Who cannot join
- Patients who have been catheterized during the third trimester of the current pregnancy
- History of surgery on the urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.
Read the detailed description
Secondarily, we will evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of acute urine retention (first voiding volume > 500cc) and on post-partum bacteriuria rates.
- Conditions
- Postpartum Women
- Being tested
- Catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatheterizationProcedure or surgery
Women in this group will be systematically catheterized before leaving the delivery room.
| Study group | Role | What they receive |
|---|---|---|
| Before group | Women in this group are included before the implementation of a strategy of systematic catheterization (they will not be catheterized). | |
| After group | Women in this group are included after the implementation of a department-wide strategy of systematic catheterization.
Intervention: catheterization Receives: Procedure: Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of a post-voiding residue
Assessed just after the first post-partum voiding.
Measured: Day 0 to Day 2 (just after first voiding)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Neron, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597413
- Sponsor's protocol ID
- LOCAL/2015/MN-01
- Acronym
- RPM-Eval
- Status last verified
- May 2016
- First submitted
- 4 Nov 2015
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study
- ClinicalTrials.gov ID
- NCT02597413
- Acronym / sponsor ID
- RPM-Eval / LOCAL/2015/MN-01
- Conditions
- Postpartum Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Nov 2015 (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.
The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.
Detailed description
Secondarily, we will evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of acute urine retention (first voiding volume > 500cc) and on post-partum bacteriuria rates.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before group | – | –Women in this group are included before the implementation of a strategy of systematic catheterization (they will not be catheterized). |
| After group | – | Procedure: CatheterizationWomen in this group are included after the implementation of a department-wide strategy of systematic catheterization. Intervention: catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is all paturient women admitted to delivery rooms.
Key inclusion criteria (1 listed)
- Paturient women admitted to the delivery room
Key exclusion criteria (2 listed)
- Patients who have been catheterized during the third trimester of the current pregnancy
- History of surgery on the urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CatheterizationWomen in this group will be systematically catheterized before leaving the delivery room. | Procedure or surgery | After group |
Primary outcome
Presence/absence of a post-voiding residue
Time frame: Day 0 to Day 2 (just after first voiding)
Assessed just after the first post-partum voiding.
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 24 May 2016.
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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.
Mathias Neron principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Postpartum Women, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 1 inclusion and 2 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 24 May 2016. 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 France. 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?
Presence/absence of a post-voiding residue (time frame: Day 0 to Day 2 (just after first voiding)). 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 24 May 2016.