Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 5:15 PM
Study NCT ID:
NCT06795334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Impact of Induced Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-25', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-25', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'artificial abortion', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'medical abortion', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-medical Abortion Surgery']}, 'descriptionModule': {'briefSummary': "Through prospective observation of the queue, the risks of mid to long term complications for Chinese women caused by surgical and medical abortion, as well as their potential impacts on women's fertility, pregnancy complications/comorbidities, and maternal and infant health, are identified. This provides scientific evidence for the assessment, protection, and preservation of fertility among Chinese women of childbearing age, and decision-making basis for the development and improvement of artificial abortion and fertility policies and guidelines for the country."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who voluntarily request non-medical abortion surgery, early pregnancy (≤ 10 weeks of gestation); Age range: 20-40 years old (inclusive); Willingness to have another child; No long-term intention to go abroad during the research period; Willing to accept regular postoperative follow-up and voluntarily sign an informed consent form.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who voluntarily request non-medical abortion surgery, early pregnancy (≤ 10 weeks of gestation); Age range: 20-40 years old (inclusive); Willingness to have another child; No long-term intention to go abroad during the research period; Willing to accept regular postoperative follow-up and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n* Pathological miscarriage such as spontaneous abortion and missed abortion; Difficulty in reading, writing, or understanding; Other situations deemed unsuitable for inclusion by doctors.'}, 'identificationModule': {'nctId': 'NCT06795334', 'briefTitle': 'Long Term Impact of Induced Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Long Term Impact of Induced Abortion: a Multicenter Prospective Cohort Study in China', 'orgStudyIdInfo': {'id': 'ChiCTR2400089586'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xinyan Liu, Ph.D', 'role': 'CONTACT', 'email': '4826645@qq.com', 'phone': '+86 186 0000 8013'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}