NCT02597413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

November 4, 2015

Last Update Submit

May 23, 2016

Conditions

Postpartum Women

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of a post-voiding residue

    Assessed just after the first post-partum voiding.

    Day 0 to Day 2 (just after first voiding)

Study Arms (2)

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

CatheterizationPROCEDURE

Women in this group will be systematically catheterized before leaving the delivery room.

After group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Paturient women admitted to the delivery room

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Interventions

Catheterization

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Mathias Neron

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 5, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

FR(1)