Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT01678703
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2012-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-30', 'studyFirstSubmitDate': '2012-08-22', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The degree of difficulty to accomplish the abortion', 'timeFrame': 'at the time of performing the surgical abortion', 'description': 'The difficulty score will be recorded by the surgeon at the operating room immediately upon completion of the procedure.'}], 'primaryOutcomes': [{'measure': 'Initial cervical opening and the need for further dilatation at the start of the procedure', 'timeFrame': '8-12 hours after insersion of laminaria or Misoprostol', 'description': 'The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol'}], 'secondaryOutcomes': [{'measure': 'pain score during cervical preparation and after the procedure', 'timeFrame': 'at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia', 'description': 'The pain score will be accessed immediately after the insertion of the laminaria or the vaginal Misoprostol.\n\nPain score will be recorded again right before performing the abortion and will address the 8-12 hours elapsed from the insertion.\n\nAnother assessment of pain will be recorded immediately after the abortion following recovery from general anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['late abortion', 'laminaria', 'Misoprostol', 'Cervical preparation'], 'conditions': ['Induced; Abortion, Nonmedical']}, 'descriptionModule': {'briefSummary': 'This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.\n\nThe investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.\n\nThe investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.', 'detailedDescription': 'This is a prospective randomized study.\n\nThe aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.\n\nPrimary outcome measures will include:\n\nInitial cervical opening and the need for further dilatation at the procedure Procedure duration\n\nDifficulty score performing the abortion\n\nComplications during and after the procedure\n\nAssessment of pain, using VAS scale, and the need for analgesia before and after the procedure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients with a viable singleton\n* Pregnancy 14-20 weeks of gestation\n* Admitted for termination of pregnancy\n\nExclusion Criteria:\n\n* Contraindication for administration of Misoprostol\n* Patients with more than one previous cesarean section scar\n* Patients with impaired coagulation\n* Significant pulmonary or cardiac disease\n* Non viable pregnancy\n* Placenta accreta or previa by ultrasound'}, 'identificationModule': {'nctId': 'NCT01678703', 'briefTitle': 'Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion', 'orgStudyIdInfo': {'id': '2trimabort.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laminaria group', 'description': 'Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion', 'interventionNames': ['Device: Laminaria, MedGyn Products, Inc. USA.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol group', 'description': 'Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Laminaria, MedGyn Products, Inc. USA.', 'type': 'DEVICE', 'otherNames': ['laminaria tents'], 'description': 'Insertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance.', 'armGroupLabels': ['Laminaria group']}, {'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': 'Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion', 'armGroupLabels': ['Misoprostol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Ron Sagiv, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tel Aviv University, Sackler Medical School, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}