Determination of Risk Factors of Postpartum Urinary Retention (PAUR)

March 13, 2019 updated by: Hospices Civils de Lyon

Determination of Risk Factors of Postpartum Urinary Retention: a Retrospective Case-control Study

Postpartum urinary retention is an uncommon complication of the vaginal delivery. Failure to diagnose it may have a real impact both on the urinary plane but also on the psychological level.

The hypothesis is that the identification of risk factors for the emergence of acute urinary retention would allow preventive management. The investigator conducted a retrospective, comparative, case-control study, including 2 groups of 96 patients who have had a vaginal delivery in the department between 2011 and 2015. The first group included patients with postpartum acute urinary retention (PAUR). The second group, control group, without PAUR, was selected randomly, respecting a 1:1 matching criteria, including the year of delivery and the age of the patient at delivery. The goal was to identify the potential risk factors of post-partum acute urinary retention in order to define a better prevention.

Study Overview

Study Type

Observational

Enrollment (Actual)

192

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

      • Bron, France
        • Hôpital Femme Mère Enfant

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

Probability Sample

Study Population

Patients who have had a vaginal delivery, between 2011 and 2015, in the obstetrics and gynecology department, at the Femme Mère Enfant Hospital, Hospices Civils de Lyon, France.

The control group, without PAUR, was selected randomly, respecting a 1:1 matching criteria, including the year of delivery and the age of the patient at delivery.

Description

Inclusion Criteria:

  • vaginal delivery
  • between 2011 and 2015
  • postpartum acute urinary retention for the first group / without postpartum acute urinary retention for the second group

Exclusion Criteria:

  • caesarean section

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PAUR (postpartum acute urinary retention)
patients presenting postpartum acute urinary retention.
Collection of risk factors
Other Names:
  • Collection of risk factors in patients with postpartum acute urinary retention
Control
patients without postpartum acute urinary retention. This group was selected randomly, respecting a 1:1 matching criteria, including the year of delivery and the age of the patient at delivery.
Collection of risk factors
Other Names:
  • Collection of risk factors in patients without postpartum acute urinary retention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gestity
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
parity
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
number of patients with urological antecedents
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
number of patients with antecedent of PAUR
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
presentation of baby
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
labor duration
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
duration of second stage of labor
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
instrumental delivery
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
dose of local anesthetic for epidural anesthesia
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
duration of epidural anesthesia
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
number of patients with intact perineum after delivery
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
number of patients with spontaneous voiding before leaving the delivery room
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
number of patients with vulvar edema
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015
number of patients with perineal hematoma
Time Frame: between 2011 and 2015
criteria that may influence the occurrence of postpartum acute urinary retention (risk factors) : criteria related to the patient's history (gestity, parity, urological antecedents, antecedent of PAUR), related to delivery (presentation, labor duration, duration of second stage of labor, instrumental delivery), related to anesthesia (dose of local anesthetic for epidural anesthesia, duration of epidural anesthesia), related to postpartum events (intact perineum after delivery, spontaneous voiding before leaving the delivery room, vulvar edema, perineal hematoma)
between 2011 and 2015

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Géry LAMBLIN, Pr, Hospices Civils de Lyon

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 (Actual)

March 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 17-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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