Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-17 @ 2:20 PM
Study NCT ID:
NCT02792556
Status:
UNKNOWN
Last Update Posted:
2018-08-09
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative predictive value of urine pregnancy test CHECK TOP', 'timeFrame': 'During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)', 'description': 'Negative predictive value of urine pregnancy test CHECK TOP taking as reference transvaginal ultrasound.\n\nA negative result at transvaginal ultrasound will be defined as the absence of ongoing pregnancy. An ongoing pregnancy is characterized by the presence of gestational sac, yolk sac and/or embryo with cardiac activity. A positive result will be retained only in case of ongoing pregnancy.\n\nCheck Top test will be considered as negative if only one colored line appears in the control window, without any line in the result window. It will be considered as positive if two colored lines are present in the result window, corresponding to a β-HCG level \\> 1000 IU/ml.'}], 'secondaryOutcomes': [{'measure': 'Positive predictive value of urine pregnancy test Check Top', 'timeFrame': 'During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)', 'description': 'Positive predictive value of urine pregnancy test Check Top compared to transvaginal ultrasound.'}, {'measure': 'Sensibility of urine pregnancy test Check Top', 'timeFrame': 'During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)', 'description': 'Sensibility of urine pregnancy test Check Top compared to transvaginal ultrasound.'}, {'measure': 'Specificity of urine pregnancy test Check Top', 'timeFrame': 'During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)', 'description': 'Specificity of urine pregnancy test Check Top compared to transvaginal ultrasound.'}, {'measure': 'Acceptability of urine pregnancy test Check Top by patients.', 'timeFrame': 'During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug abortion', 'urine pregnancy test', 'negative predictive value', 'check Top test', 'transvaginal ultrasound'], 'conditions': ['Drug Abortion']}, 'descriptionModule': {'briefSummary': "According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.\n\nThe success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.\n\nThe control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.\n\nIn the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.\n\nTo simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.\n\nThe main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.\n\nThis is a monocentric observational study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Women ≥18 years of age\n * Undergoing drug abortion in Orthogenic Departement, Croix-Rousse Hospital, Lyon\n * Intrauterine pregnancy, single or multiple, until 8 weeks of amenorrhea\n * Agreeing to participate in the study after receiving information note\n * Affiliated to a social security system\n * Not subject to a measure of legal protection\n* Exclusion Criteria:\n\n * Women \\<18 years\n * Ineligible patient to drug abortion\n * Patient practicing a surgical abortion'}, 'identificationModule': {'nctId': 'NCT02792556', 'acronym': 'CHECK-TOP', 'briefTitle': 'Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).', 'orgStudyIdInfo': {'id': '69HCL16_0263'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient having a drug abortion', 'description': 'Urine pregnancy test for adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake.', 'interventionNames': ['Device: Urine pregnancy test']}], 'interventions': [{'name': 'Urine pregnancy test', 'type': 'DEVICE', 'description': 'Urine pregnancy test Check Top after transvaginal ultrasound', 'armGroupLabels': ['patient having a drug abortion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corinne REBELLE', 'role': 'CONTACT', 'email': 'corine.rebelle@chu-lyon.fr', 'phone': '+33 4 72 07 16 63'}], 'facility': 'Hospices Civils de Lyon - Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Corine REBELLE, MD', 'role': 'CONTACT', 'email': 'corine.rebelle@chu-lyon.fr', 'phone': '+33 4 72 07 16 63'}, {'name': 'Mahé RAFFIN', 'role': 'CONTACT', 'email': 'mahe.raffin@chu-lyon.fr', 'phone': '+33 4.26.73.27.38'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}