Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-27 @ 5:40 PM
Study NCT ID:
NCT01269450
Status:
TERMINATED
Last Update Posted:
2018-06-06
First Post:
2011-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progesterone and Second Trimester Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}, {'id': 'C000624167', 'term': 'Utrogestan'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of spontaneous preterm birth - before 37 weeks.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Maternal and fetal outcomes', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['second trimester vaginal bleeding', 'late abortion', 'preterm birth', 'progesterone'], 'conditions': ['Antepartum Bleeding', 'Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '31087325', 'type': 'DERIVED', 'citation': 'Salim R, Hakim M, Zafran N, Nachum Z, Romano S, Garmi G. Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding. Acta Obstet Gynecol Scand. 2019 Oct;98(10):1318-1325. doi: 10.1111/aogs.13641. Epub 2019 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'Working hypothesis and aims:\n\nTo investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.\n\nThe participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Viable pregnancy\n* Gestational age between 13 to 26 weeks\n* Vaginal bleeding from uterine origin\n* Singleton pregnancy\n* Normal clotting tests\n* Hemodynamically stable woman\n\nExclusion Criteria:\n\n* Water leak\n* Signs of preterm labor\n* Fetal malformations incompatible with life\n* Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state\n* Past preterm birth'}, 'identificationModule': {'nctId': 'NCT01269450', 'briefTitle': 'Progesterone and Second Trimester Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '0023-08-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Utrogestan', 'interventionNames': ['Drug: micronized progesterone 200 mg (Utrogestan)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'micronized progesterone 200 mg (Utrogestan)', 'type': 'DRUG', 'description': 'micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily', 'armGroupLabels': ['Utrogestan']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo 200mg vaginal tablets', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Emek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Hadera', 'country': 'Israel', 'facility': 'dEP ob/gyn, Hillel Yaffe Medical Center.', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'city': 'Nazareth', 'country': 'Israel', 'facility': 'Dep. OB/GYN, The Nazareth Hospital, E.M.M.S', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}], 'overallOfficials': [{'name': 'RAED SALIM, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Raed Salim', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}