Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-10 @ 10:40 PM
Study NCT ID:
NCT02304835
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2014-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.', 'timeFrame': 'At the follow-up at 2-3 weeks after inclusion', 'description': 'There was concordance if :\n\n* The result of urinary test is \\< 1000 IU/L and the value of β-hCG blood measurement was \\< 1000 IU/L, Or if\n* The result of urinary test is ≥ 1000 iu/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.\n\nThere was discrepancy if:\n\n* The result of urinary test is ≥ 1000 IU/L and the value of β-hCG blood measurement was \\< 1000 IU/L, Or if\n* The result of urinary test is \\< 1000 IU/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the urinary semi-quantitative test by the patient', 'timeFrame': 'at the follow up at 2-3 weeks after the inclusion', 'description': 'The analysis of the acceptability is descriptive:\n\n* The rate of patients who performed the urinary test.\n* Assessment of the urinary test by physicIan : very easy/easy/difficult/Impossible\n* The assessment by the patient: questionnaire (Have you found the explanations given sufficient for performing the test?, How did you find the carrying out of this test? What are your feelings about checking the results of the medical abortion yourself?)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abortion; Attempted, Medical']}, 'descriptionModule': {'briefSummary': 'This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.\n\nThe aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women asking for medical abortion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.\n* Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.\n* Informed patients accepting the computer processing of their medical data and their right of access and correction.\n\nExclusion Criteria:\n\n* Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.\n* Patients with contraindications to medical abortion.\n* Patients with severe and progressive disease.\n* Patients unable to complete a questionnaire.\n* Patients refusing to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02304835', 'briefTitle': 'Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Pharma SAS'}, 'officialTitle': 'Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion', 'orgStudyIdInfo': {'id': 'BETINA'}}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Cabinet Médical', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Danielle HASSOUN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cabinet Médical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Pharma SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}