Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT02669420
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2016-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol for Second Trimester Pregnancy Termination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2016-01-23', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean duration from the initial misoprostol dose until complete fetal expulsion', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intra Uterine Fetal Death']}, 'referencesModule': {'references': [{'pmid': '34061352', 'type': 'DERIVED', 'citation': 'Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy 13-24 weeks.\n* Women with indication for termination of the pregnancy due to intra uterine fetal death\n\nExclusion Criteria:-Pregnancy before 13 weeks.\n\n* Pregnancy beyond 24 weeks.\n* Women with scared uterus.\n* Known hypersensitivity for misoprostol.\n* Refusal of the woman to participate.'}, 'identificationModule': {'nctId': 'NCT02669420', 'acronym': 'MIS', 'briefTitle': 'Misoprostol for Second Trimester Pregnancy Termination', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extra amniotic misoprostol', 'description': 'misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours)', 'interventionNames': ['Procedure: termination of second trimester pregnancy']}, {'type': 'EXPERIMENTAL', 'label': 'vaginal misoprostol', 'description': 'misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours)', 'interventionNames': ['Procedure: termination of second trimester pregnancy']}], 'interventions': [{'name': 'termination of second trimester pregnancy', 'type': 'PROCEDURE', 'description': 'Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial', 'armGroupLabels': ['extra amniotic misoprostol', 'vaginal misoprostol']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'abo bakr mitwally', 'investigatorAffiliation': 'Assiut University'}}}}