- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876756
Determination of Risk Factors of Postpartum Urinary Retention (PAUR)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bron, France
- Hôpital Femme Mère Enfant
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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.
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Collection of risk factors
Other Names:
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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:
|
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)
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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
Sponsor
Investigators
- Principal Investigator: Géry LAMBLIN, Pr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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