Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT04664660
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometriosis and Obstetric Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm delivery', 'timeFrame': 'Time of delivery', 'description': 'Incidence of delivery before 37 weeks of pregnancy'}, {'measure': 'Gestational diabetes', 'timeFrame': "after 18 weeks' pregnancy", 'description': 'fasting blood glucose \\>17 mmol/L'}, {'measure': 'Gestational hypertension', 'timeFrame': "after 20 weeks' gestation", 'description': 'blood pressure persistently \\> 140/90 mm Hg'}, {'measure': 'Assisted reproduction technologies', 'timeFrame': 'before pregnancy', 'description': 'Patients who referred to assisted reproduction technologies'}, {'measure': 'Cesarean Section', 'timeFrame': 'Time of delivery', 'description': 'Robson Classifications'}, {'measure': 'Postpartum hemorrhage', 'timeFrame': 'Time of delivery', 'description': 'Greater than 500 mL estimated blood loss in a vaginal delivery or greater than 1000 mL estimated blood loss at the time of cesarean delivery'}, {'measure': 'Birth-weight', 'timeFrame': 'Time of delivery', 'description': 'small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight over the 90th percentile)'}, {'measure': 'Apgar scores', 'timeFrame': 'Time of delivery', 'description': 'Apgar scores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Obstetric outcome', 'Delivery outcome', 'Neonatal outcome'], 'conditions': ['Endometriosis', 'Obstetric Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes', 'detailedDescription': 'This is a retrospective, observational, case-control study. Pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. Women with endometriosis will be matched to controls by age. A database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020. Women with a histological diagnosis of endometriosis before pregnancy matched by age with healthy controls.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020\n* Histologic diagnosis of endometriosis before pregnancy for case group\n* Age matched healthy patients for control group\n\nExclusion Criteria:\n\n* Clinical records not available'}, 'identificationModule': {'nctId': 'NCT04664660', 'briefTitle': 'Endometriosis and Obstetric Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Modena'}, 'officialTitle': 'Endometriosis and Risk Factors in Pregnancy, Labor and Delivery', 'orgStudyIdInfo': {'id': 'EndoPreg01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with previous histologic diagnosis of endometriosis', 'interventionNames': ['Other: Retrospective analysis of obstetrics outcomes']}, {'label': 'Patient without endometriosis', 'interventionNames': ['Other: Retrospective analysis of obstetrics outcomes']}], 'interventions': [{'name': 'Retrospective analysis of obstetrics outcomes', 'type': 'OTHER', 'description': 'Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.', 'armGroupLabels': ['Patient without endometriosis', 'Patients with previous histologic diagnosis of endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41125', 'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Alboni, MD, PhD', 'role': 'CONTACT', 'email': 'alboni.carlo@aou.mo.it', 'phone': '0594224387'}], 'facility': 'Carlo Alboni', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'centralContacts': [{'name': 'Carlo Alboni', 'role': 'CONTACT', 'email': 'alboni.carlo@aou.mo.it', 'phone': '0594224387'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I prefer not to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy', 'investigatorFullName': 'Carlo Alboni, MD, PhD', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Modena'}}}}