Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 10:50 AM
Study NCT ID:
NCT03876756
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2019-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Risk Factors of Postpartum Urinary Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-06', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gestity', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'parity', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'number of patients with urological antecedents', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'number of patients with antecedent of PAUR', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'presentation of baby', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'labor duration', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'duration of second stage of labor', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'instrumental delivery', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'dose of local anesthetic for epidural anesthesia', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'duration of epidural anesthesia', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'number of patients with intact perineum after delivery', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'number of patients with spontaneous voiding before leaving the delivery room', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'number of patients with vulvar edema', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}, {'measure': 'number of patients with perineal hematoma', 'timeFrame': 'between 2011 and 2015', 'description': "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)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Acute Urinary Retention']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vaginal delivery\n* between 2011 and 2015\n* postpartum acute urinary retention for the first group / without postpartum acute urinary retention for the second group\n\nExclusion Criteria:\n\n* caesarean section'}, 'identificationModule': {'nctId': 'NCT03876756', 'acronym': 'PAUR', 'briefTitle': 'Determination of Risk Factors of Postpartum Urinary Retention', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Determination of Risk Factors of Postpartum Urinary Retention: a Retrospective Case-control Study', 'orgStudyIdInfo': {'id': '17-020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PAUR (postpartum acute urinary retention)', 'description': 'patients presenting postpartum acute urinary retention.', 'interventionNames': ['Other: postpartum acute urinary retention']}, {'label': 'Control', 'description': '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.', 'interventionNames': ['Other: no postpartum acute urinary retention']}], 'interventions': [{'name': 'postpartum acute urinary retention', 'type': 'OTHER', 'otherNames': ['Collection of risk factors in patients with postpartum acute urinary retention'], 'description': 'Collection of risk factors', 'armGroupLabels': ['PAUR (postpartum acute urinary retention)']}, {'name': 'no postpartum acute urinary retention', 'type': 'OTHER', 'otherNames': ['Collection of risk factors in patients without postpartum acute urinary retention'], 'description': 'Collection of risk factors', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Géry LAMBLIN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}