Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 10:41 PM
Study NCT ID:
NCT06130150
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Function in High-risk Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1', 'timeFrame': '1 day', 'description': 'High-risk pregnant women have lower FSFI score results then normal pregnant women'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-risk pregnancy', 'perinatology', 'sexual dysfunction', 'female sexual function', 'fsfi'], 'conditions': ['High Risk Pregnancy', 'Sexual Dysfunction', 'Anxiety', 'Female Sexual Function']}, 'descriptionModule': {'briefSummary': 'Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women between the ages of 18-40 who were diagnosed with risky pregnancy for any reason during their pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: - Pregnant women over 18 years old, -Pregnant women 39 years old and under, -Pregnant women in their 3rd trimester.\n\nExclusion Criteria: - Pregnant women under 18 years old, -Pregnant women over 40 years old, -Pregnant women in their 1st or 2nd trimester.'}, 'identificationModule': {'nctId': 'NCT06130150', 'briefTitle': 'Sexual Function in High-risk Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Evaluation of Sexual Function in High-risk Pregnant Women', 'orgStudyIdInfo': {'id': 'KBU-EMEKLIOGLU-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-risk', 'description': 'This group includes pregnant women with the risk factors determined in the study'}, {'label': 'Normal', 'description': 'This group includes pregnant women with no risk'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'state': 'Sisli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Aylin Ozkahraman, MD', 'role': 'CONTACT', 'email': 'aylinozkahraman@icloud.com', 'phone': '+905069123510'}], 'facility': 'Prof. Dr. Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Cagdas Nurettin Emeklioglu, MD', 'role': 'CONTACT', 'email': 'c.n.emeklioglu@gmail.com', 'phone': '+905359129913'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Cagdas Nurettin Emeklioglu', 'investigatorAffiliation': 'Karabuk University'}}}}