Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04133402
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2019-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fertility After Intrauterine Tamponing Balloon: Where Are we
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of infertility', 'timeFrame': '7 years', 'description': 'defined as the absence of pregnancy after 12 months of attempted pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy', 'timeFrame': '7 years'}, {'measure': 'Frequency of gynecological complications after use of an intrauterine tamponade balloon.', 'timeFrame': '7 years'}, {'measure': 'Type of gynecological complications after use of an intrauterine tamponade balloon.', 'timeFrame': '7 years', 'description': 'type = infections , pelvic pain, cycle disorders'}, {'measure': 'the frequency of obstetric complications for the next pregnancy', 'timeFrame': '7 years'}, {'measure': 'type of obstetrical complications', 'timeFrame': '7 years', 'description': 'complications = intrauterine growth retardation, threat of premature labor'}, {'measure': 'Frequency of recurrent postpartum haemorrhage in the next pregnancy', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemorrhage Post-partum', 'Fertility', 'Uterine balloon tamponade', 'Vaginal Birth'], 'conditions': ['Hemorrhage Postpartum', 'Fertility Disorders']}, 'descriptionModule': {'briefSummary': "Today, few data are available on the patient's fertility following intrauterine tamponade balloon (BTIU) used for postpartum hemorrhage (PPH) after vaginal delivery (AVB). Several studies have concluded that there are no fertility disorders after conservative surgical treatment or embolization. BTIU is an essential treatment in the management of PPH. The aim was to evaluate post-BTIU fertility and the appearance of gynecological symptoms.\n\nThis is a bicentric retrospective study (Valenciennes, Lille, France), between 2012 and 2017. The data will be collected by telephone interview on fertility and various gynecological functional symptoms."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major patients with postpartum haemorrhage after vaginal delivery between 2012 and 2017 in Valenciennes maternity and the CHRU Lille, treated by intrauterine tamponade therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaginal birth\n* Post partum haemorrhage\n* Intrauterine tamponing balloon\n* Between 2012 and 2017\n* CHRU Lille and CH Valenciennes\n\nExclusion Criteria:\n\n* Minor patients\n* Initial intake started in another center (postpartum transfer).\n* Refusal to participate in the study\n* Invasive treatments for postpartum haemorrhage\n* Caesarean'}, 'identificationModule': {'nctId': 'NCT04133402', 'acronym': 'FERTIBTIU', 'briefTitle': 'Fertility After Intrauterine Tamponing Balloon: Where Are we', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of Fertility of Patients With a History of Postpartum Hemorrhage, Complicating Low-dose Delivery With Intrauterine Tamponade Treatment', 'orgStudyIdInfo': {'id': '2017_89'}, 'secondaryIdInfos': [{'id': '2018-A01609-46', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Charles Garabedian, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}