Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-18 @ 8:19 PM
Study NCT ID:
NCT02581761
Status:
UNKNOWN
Last Update Posted:
2015-10-21
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy', 'timeFrame': 'two weeks for each patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodynamically stable women >18 years old', 'with abnormal plateauing serum βHCG'], 'conditions': ['Pregnancies of Unknown Location (PUL)']}, 'descriptionModule': {'briefSummary': 'A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.', 'detailedDescription': 'A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.\n\nThe management of asymptomatic patients with pregnancies of unknown location (PUL) remains a challenge. Determining the location of the pregnancy is the first priority in the evaluation of these women. Some of these asymptomatic women present with inappropriate raising beta-human chorionic gonadotropin (βHCG), while others have assurance of pregnancy duration (e.g. IVF pregnancies) with no sonographic evidence of intra or extra uterine pregnancy. Most of the PULs are failed intra-uterine pregnancies.\n\nThe main concern regarding PUL is the late diagnosis of an ectopic pregnancy (EP). Some studies report that between 5 and 42% of women seen for US assessment with a positive pregnancy test have a PUL and only 6-20% will subsequently diagnosed with EP (1). Other studies report that 94% of PUL will resolve spontaneously, and out of the 6% that did not spontaneously resolve 68.9 % were finally diagnosed with failed IUP and only 5.6% were diagnosed with EP (2).\n\nWomen with PUL should be evaluated in minimum time, but also with minimal invasiveness. Management that will resolve such pregnancies in a rapid manner will save time and money and possibly avoid unnecessary administration of MTX or surgical intervention.\n\nSeveral protocols have been investigated in order to fasten the diagnosis of PUL. For example, obtaining serial β-HCG, the first one in the initial presentation, two days later and seven days later (3). Another protocol suggested endometrial sampling by D\\&C or aspiration of uterine continents with Karman cannula and checking the β-HCG after 24 hours (2).\n\nPurpose: The aim of our study will be to prospectively assess the use of misoprostol in asymptomatic patients with pregnancies of unknown location(PUL).\n\nThe study group will contain hemodynamically stable women \\>18 years old with a PUL with abnormal plateauing serum β-HCG trend (increase\\<53%or decrease \\<15% in 2 days) \\< 1000 IU/l and a pelvic ultrasound unremarkable for an intrauterine pregnancy (IUP) or an ectopic pregnancy (EP).\n\nEach participant will get Vaginal misoprostol 800 mcg or placebo. Main Outcome Measure(s): The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (\\<2 IU/l) by the initial intervention strategy. Secondary outcome measures will include additional treatment (e.g. methotrexate (MTX) administration or laparoscopy), side effects and serum β-HCG clearance time, features of the optimal candidates for treatment by cytotec.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemodynamically stable women \\>18 years old with a PUL with abnormal plateauing serum βHCG trend\n\nExclusion Criteria:\n\n* Hemoglobin\\<10'}, 'identificationModule': {'nctId': 'NCT02581761', 'acronym': 'amalis', 'briefTitle': 'A Prospective Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'A Randomized Prospective Double Blind Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location', 'orgStudyIdInfo': {'id': 'SHEBA-14-1327-IA-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cytotec treatment group', 'description': 'patient with pregnancy of unkown location will receive cytotec 800 mcg per vaginal', 'interventionNames': ['Drug: CYTOTEC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment group', 'description': 'patient with pregnancy of unkown location will receive suppository which contain Whitepsol H-15 with no active material (Cytotec).', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CYTOTEC', 'type': 'DRUG', 'otherNames': ['Misoprostol'], 'description': 'synthetic prostaglandin E1', 'armGroupLabels': ['Cytotec treatment group']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Whitepsol H-15'], 'description': 'no active material', 'armGroupLabels': ['Placebo treatment group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'Dr. Isa Amal', 'investigatorAffiliation': 'Sheba Medical Center'}}}}