Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04685694
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of RPOC After Induced Abortion
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RPOC rate', 'timeFrame': '2 months', 'description': 'RPOC rate in repeat ultrasound scan performed 5 weeks after randomization'}], 'secondaryOutcomes': [{'measure': 'Adhesions', 'timeFrame': '2 months', 'description': 'According to our study protocol all women with persistent products of conception diagnosed on repeated ultrasound examination undergo hysteroscopy. During hysteroscopy, assessment of the uterine cavity including intrauterine adhesion formation will be performed. Intrauterine adhesions will be classified according to the American Society for Reproductive Medicine (ASRM), based on the extent of cavity involvement (\\<1/3; 1/3 to 2/3, \\>2/3) and the type of adhesion seen (filmy, filmy and dense, dense).'}, {'measure': 'Bleeding', 'timeFrame': '2 months', 'description': 'Bleeding pattern will be assessed via questionnaire upon recruitment and follow up visits. Bleeding will be characterized by its pattern (regular, intermenstrual) and quantity (normal, hypomenorrhoea, menorrhagia).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RPOC, induced abortion, misoprostol'], 'conditions': ['Abortion Induced Complicated']}, 'referencesModule': {'references': [{'pmid': '16707509', 'type': 'BACKGROUND', 'citation': 'Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.'}, {'pmid': '14747165', 'type': 'BACKGROUND', 'citation': 'Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. doi: 10.1093/humrep/deh049.'}, {'pmid': '24417417', 'type': 'BACKGROUND', 'citation': 'Ashwal E, Melamed N, Hiersch L, Wiznitzer A, Yogev Y, Peled Y. The incidence and risk factors for retained placenta after vaginal delivery - a single center experience. J Matern Fetal Neonatal Med. 2014 Dec;27(18):1897-900. doi: 10.3109/14767058.2014.883374. Epub 2014 Feb 4.'}, {'pmid': '28891361', 'type': 'BACKGROUND', 'citation': 'Anteby M, Many A, Ashwal E, Yogev Y, Shinar S. Risk factors and complications of manual placental removal after vaginal delivery - how common are additional invasive procedures? J Matern Fetal Neonatal Med. 2019 Feb;32(3):384-388. doi: 10.1080/14767058.2017.1379071. Epub 2017 Sep 19.'}, {'pmid': '35752301', 'type': 'DERIVED', 'citation': 'Tzur Y, Berkovitz-Shperling R, Goitein Inbar T, Bar-On S, Gil Y, Levin I, Cohen A. Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study. Am J Obstet Gynecol. 2022 Oct;227(4):599.e1-599.e9. doi: 10.1016/j.ajog.2022.06.025. Epub 2022 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion', 'detailedDescription': 'An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 \\< age \\< 45 year old\n* Thick irregular endometrium \\>12 mm on trans-vaginal ultrasound\n\nExclusion Criteria:\n\n* Endometritis\n* Cervical opening \\> 1 cm\n* Uterine abnormalities\n* Contraindication to Misoprostol treatment'}, 'identificationModule': {'nctId': 'NCT04685694', 'acronym': 'RPOC', 'briefTitle': 'Management of RPOC After Induced Abortion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion', 'orgStudyIdInfo': {'id': '0444-19-TLV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Expectant', 'description': 'No medication is assigned.'}, {'type': 'EXPERIMENTAL', 'label': 'Medical', 'description': 'SL 800 mcg Misoprostol', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': 'sl 800 mcg misoprostol', 'armGroupLabels': ['Medical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Medical Center; ,', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Yossi Tzur, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tel Aviv Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'on line sharing via secured system', 'accessCriteria': 'for research purposes only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD. Deputy Director Research & Development', 'investigatorFullName': 'Eli Sprecher, MD', 'investigatorAffiliation': 'Tel-Aviv Sourasky Medical Center'}}}}