NCT03876756

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

4.6 years

First QC Date

March 6, 2019

Last Update Submit

March 13, 2019

Conditions

Postpartum Acute Urinary Retention

Outcome Measures

Primary Outcomes (14)

  • gestity

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

PAUR (postpartum acute urinary retention)

patients presenting postpartum acute urinary retention.

Other: 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.

Other: no postpartum acute urinary retention

Interventions

postpartum acute urinary retentionOTHER

Collection of risk factors

Also known as: Collection of risk factors in patients with postpartum acute urinary retention
PAUR (postpartum acute urinary retention)
no postpartum acute urinary retentionOTHER

Collection of risk factors

Also known as: Collection of risk factors in patients without postpartum acute urinary retention
Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

Location

Study Officials

  • Géry LAMBLIN, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 15, 2019

Study Start

March 1, 2011

Primary Completion

October 1, 2015

Study Completion

May 1, 2017

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)