Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-02 @ 4:38 PM
Study NCT ID:
NCT03354793
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometriosis and Risk of Obstetric Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 844}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intra uterine Growth Restriction', 'timeFrame': '2 years', 'description': 'comparison of rate of IUGR fetuses in the two groups'}, {'measure': 'HELLP syndrome', 'timeFrame': '2 years', 'description': 'comparison of rate of HELLP syndrome in the two groups'}], 'primaryOutcomes': [{'measure': 'Pre-term delivery', 'timeFrame': '2 years', 'description': 'comparison of rate of preterm delivery in the two groups'}], 'secondaryOutcomes': [{'measure': 'Placenta praevia', 'timeFrame': '2 years', 'description': 'comparison of rate of placenta praevia in the two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '34623489', 'type': 'DERIVED', 'citation': "Berlanda N, Alio W, Angioni S, Bergamini V, Bonin C, Boracchi P, Candiani M, Centini G, D'Alterio MN, Del Forno S, Donati A, Dridi D, Incandela D, Lazzeri L, Maiorana A, Mattei A, Ottolina J, Orenti A, Perandini A, Perelli F, Piacenti I, Pino I, Porpora MG, Scaramuzzino S, Seracchioli R, Solima E, Somigliana E, Venturella R, Vercellini P, Vigano P, Vignali M, Zullo F, Zupi E; Endometriosis Treatment Italian Club (ETIC). Impact of endometriosis on obstetric outcome after natural conception: a multicenter Italian study. Arch Gynecol Obstet. 2022 Jan;305(1):149-157. doi: 10.1007/s00404-021-06243-z. Epub 2021 Oct 8."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis', 'detailedDescription': 'All women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All continuous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 to 50 years old women with at least one previous spontaneous pregnancy \\> 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis\n\nExclusion Criteria:\n\n* Pregnancy achieved by assisted reproductive techniques\n* Pregnancy terminated before 12 gestational weeks\n* Twin pregnancy\n* Preexisting hypertension\n* Lupus like anti-coagulant\n* Non corrected uterine malformation\n* Recurrent abortion'}, 'identificationModule': {'nctId': 'NCT03354793', 'briefTitle': 'Endometriosis and Risk of Obstetric Complications', 'organization': {'class': 'OTHER', 'fullName': 'Endometriosis Treatment Italian Club'}, 'officialTitle': 'Impact of Endometriosis on the Risk of Obstetric Complications in Spontaneous Pregnancy: a Multicentric Italian Study', 'orgStudyIdInfo': {'id': 'ETIC002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endometriosis', 'description': 'Survey on first pregnancy after endometriosis diagnosis', 'interventionNames': ['Other: Survey on first pregnancy after endometriosis diagnosis']}, {'label': 'non endometriosis', 'description': 'Survey on first pregnancy', 'interventionNames': ['Other: Survey on first pregnancy']}], 'interventions': [{'name': 'Survey on first pregnancy after endometriosis diagnosis', 'type': 'OTHER', 'description': 'Obstetric complications were noted', 'armGroupLabels': ['endometriosis']}, {'name': 'Survey on first pregnancy', 'type': 'OTHER', 'description': 'Obstetric complications were noted', 'armGroupLabels': ['non endometriosis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicola Berlanda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endometriosis Treatment Italian Club'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endometriosis Treatment Italian Club', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Milan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}