Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-02 @ 8:59 AM
Study NCT ID:
NCT04894292
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Adenomoyosis on Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '10 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-23', 'studyFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2021-05-16', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy complication', 'timeFrame': '15 month', 'description': 'Preterm labour'}], 'secondaryOutcomes': [{'measure': 'Pregnancy complication', 'timeFrame': '16 month', 'description': 'placental anomalies'}, {'measure': 'Pregnancy complication', 'timeFrame': '17 month', 'description': 'preeclampsia, eclampsia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adenomyosis', 'pregnancy complications', 'MUSA classification', 'ultrasound'], 'conditions': ['Adenomyosis', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '31374085', 'type': 'BACKGROUND', 'citation': "Harada T, Taniguchi F, Amano H, Kurozawa Y, Ideno Y, Hayashi K, Harada T; Japan Environment and Children's Study Group. Adverse obstetrical outcomes for women with endometriosis and adenomyosis: A large cohort of the Japan Environment and Children's Study. PLoS One. 2019 Aug 2;14(8):e0220256. doi: 10.1371/journal.pone.0220256. eCollection 2019."}, {'pmid': '31318420', 'type': 'BACKGROUND', 'citation': 'Horton J, Sterrenburg M, Lane S, Maheshwari A, Li TC, Cheong Y. Reproductive, obstetric, and perinatal outcomes of women with adenomyosis and endometriosis: a systematic review and meta-analysis. Hum Reprod Update. 2019 Sep 11;25(5):592-632. doi: 10.1093/humupd/dmz012.'}]}, 'descriptionModule': {'briefSummary': 'Adenomyosis can be defined as the settling of endometrial gland cells in the myometrium and deformity in the uterus and the prevalence of adenomyosis is according to the patient population and countries around 20%. There are recent publications reporting that this rate increases up to 50% in women dealing with infertility. In adenomyosis, where uterine morphology is affected, it is not thought that the uterus, which is expected to provide many morphological adaptations during pregnancy, will not be affected. Therefore, in this prospective study, it was planned to investigate the effects of adenomyosis during pregnancy.\n\nFor this study the presence of adenomyosis will be questioned by using ultrasonographic morphological uterine limitation (MUSA) in women who apply to the outpatient clinic with suspicion of pregnancy and undergo transvaginal ultrasonography for the diagnosis of pregnancy before sixth gestational week.\n\nPatients will be divided into two groups according to the presence of adenomyosis and pregnancy complications such as preterm labor, premature rupture of membranes, cesarean section rates, preeclampsia, fetal malpresentation and preeclampsia will be compared between the groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women diagnosed by TV usg before the 6th gestational week will be divided into two according to the MUSA classification, and those with adenomyosis who are not in the study group will be evaluated as the control group.\n\nAll the participants should be at between 18-35 age years old and all perinatal visits and deliveries should be at Tepecik Obstetric Clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-35 years\n* Being diagnosed before the 6th gestational week\n* Having all pregnancy follow-ups and deliveries in our hospital\n\nExclusion Criteria:\n\n* Previous uterine surgery\n* Multiple pregnancies\n* Pregnant women with uterine malformations\n* Pregnant women with fetal anomalies\n* Those who got pregnant using assisted reproductive technique'}, 'identificationModule': {'nctId': 'NCT04894292', 'briefTitle': 'The Effect of Adenomoyosis on Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Tepecik Training and Research Hospital'}, 'officialTitle': 'Adverse Obstetrical Outcomes for Women With Adenomyosis', 'orgStudyIdInfo': {'id': 'TepecikTRH-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adenomyosis Group', 'interventionNames': ['Other: Non intervention']}, {'label': 'Non-adenomyosis Group', 'interventionNames': ['Other: Non intervention']}], 'interventions': [{'name': 'Non intervention', 'type': 'OTHER', 'description': 'During the study there is no extra intervention planned for the participants.', 'armGroupLabels': ['Adenomyosis Group', 'Non-adenomyosis Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Göksel Kanmaz, Assoc. Prof.', 'role': 'CONTACT', 'email': 'drgokselkanmaz@gmail.com', 'phone': '+905308205483'}], 'facility': 'Tepecik Education and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Abdurrahman Hamdi İnan, Assoc. Prof.', 'role': 'CONTACT', 'email': 'ahamdiinan@gmail.com', 'phone': '(0232) 373 89 21'}], 'overallOfficials': [{'name': 'Ahkam Göksel Kanmaz, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tepecik Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tepecik Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof', 'investigatorFullName': 'Ahkam Göksel Kanmaz', 'investigatorAffiliation': 'Tepecik Training and Research Hospital'}}}}