Evaluation of Post-voiding Residual Urine: a Before-after... | NCT02597413

Studies
Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

NCT02597413

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

May 24, 2016Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Postpartum Women

Interventions

Catheterization

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Nov 4, 2015

First Submission Date that Met QC Criteria

Nov 4, 2015

First Posted Date

Nov 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2016

Last Update Posted Date

May 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catheterization	Procedure	Women in this group will be systematically catheterized before leaving the delivery room.	After group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence/absence of a post-voiding residue	Assessed just after the first post-partum voiding.	Day 0 to Day 2 (just after first voiding)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathias Neron	Centre Hospitalier Universitaire de Nīmes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Nîmes - Hôpital Universitaire Carémeau		Nîmes		30029	France

Intervention Browse Module

MeSH Terms

ID	Term
D002404	Catheterization

Ancestor Terms

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided