Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT04664335
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1762}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pregnancy rate'}, {'measure': 'complications', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'complications during pregnancy, delivery, puerperium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'pregnancy', 'delivery', 'miscarriage', 'cesarian section'], 'conditions': ['Endometriosis', 'Pregnancy Complications', 'Delivery Complication', 'Complication', 'Miscarriage']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo study the impact of endometriosis on subsequent pregnancy and delivery.\n\nMethods:\n\nretrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test with p \\< 0.050% being considered significant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group\n* controls: Operation because of sterility, exclusion of endometriosis during this Operation, child wish, wants to participate, correct age group\n\nExclusion Criteria:\n\n* cases / controls: declines participation, incorrect age Group, no child wish'}, 'identificationModule': {'nctId': 'NCT04664335', 'briefTitle': 'Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'Schäfer_Endo_Preg_Del_Comp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endometriosis cases', 'description': 'endometriosis laparoscopically removed / child wish', 'interventionNames': ['Other: questionnaire']}, {'label': 'controls', 'description': 'endometriosis laparoscopically excluded / child wish', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'otherNames': ['interview'], 'description': 'if no Reply to questionnaire, telephone interview', 'armGroupLabels': ['controls', 'endometriosis cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Münster Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Sebastian D Schaefer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'will share upon reasonable request according to regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Gynecology', 'investigatorFullName': 'Dr. med. Sebastian Daniel Schäfer', 'investigatorAffiliation': 'University Hospital Muenster'}}}}