Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study (RPM-Eval)

May 23, 2016 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes Cedex 09, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population is all paturient women admitted to delivery rooms.

Description

Inclusion Criteria:

  • Paturient women admitted to the delivery room

Exclusion Criteria:

  • Patients who have been catheterized during the third trimester of the current pregnancy
  • History of surgery on the urinary tract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Catheterization
Women in this group will be systematically catheterized before leaving the delivery room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 to Day 2 (just after first voiding)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Mathias Neron, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • LOCAL/2015/MN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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