Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 4:28 AM
Study NCT ID:
NCT01270334
Status:
UNKNOWN
Last Update Posted:
2011-01-05
First Post:
2011-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-04', 'studyFirstSubmitDate': '2011-01-04', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment failure- need for D&C', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'side effects, need foe analgetics, time for compliting abortion', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['MISED ABORTION- Vaginal PH']}, 'descriptionModule': {'briefSummary': 'vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women dignosed with missed abortion in the first trimester', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion\n\n* missed abortion under 8 weeks by sac diameter over 18 years old informed concent given\n\nExclusion Criteria:\n\n* missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18'}, 'identificationModule': {'nctId': 'NCT01270334', 'briefTitle': 'Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions', 'orgStudyIdInfo': {'id': 'cytoph'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ph above cutoff', 'interventionNames': ['Other: PH meassurment']}, {'label': 'PH under cutoff', 'interventionNames': ['Other: PH meassurment']}], 'interventions': [{'name': 'PH meassurment', 'type': 'OTHER', 'description': 'meassuring ph USING PROBE', 'armGroupLabels': ['PH under cutoff', 'ph above cutoff']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'contacts': [{'name': 'shira baram, md', 'role': 'CONTACT', 'phone': '972-4-6494035'}, {'name': 'shira baram, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Haemel Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'centralContacts': [{'name': 'shira baram, dr', 'role': 'CONTACT', 'email': 'shira_ba@clalit.org.il', 'phone': '972-4-6494035'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'doctor baram shira', 'oldOrganization': 'HaEmek Medical Center'}}}}