Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-16 @ 9:05 PM
Study NCT ID:
NCT05001061
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2021-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-10-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurance of complete abortion within 24 hours with Misoprostol drug', 'timeFrame': 'Within 24 hours', 'description': 'Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion'}, {'measure': 'Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug', 'timeFrame': 'within 24 hours', 'description': 'Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Missed Abortion']}, 'referencesModule': {'references': [{'pmid': '32700359', 'type': 'BACKGROUND', 'citation': 'Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1.'}, {'pmid': '17963768', 'type': 'BACKGROUND', 'citation': 'Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion', 'detailedDescription': 'study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with an ultrasound diagnosis of missed abortion \\< 13 weeks gestation without any clinical criteria of Inevitable abortion.\n\nExclusion Criteria:\n\n* Patients refused the medical treatment.\n* Patients have contraindications of the drug (Misoprostol).\n* Missed abortion associated with any signs of sepsis'}, 'identificationModule': {'nctId': 'NCT05001061', 'briefTitle': 'Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion', 'orgStudyIdInfo': {'id': 'Misoprostol abortion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sublingual Misoprostol for termination of first trimester missed abortion', 'description': 'Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses', 'interventionNames': ['Drug: Misoprostol Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal Misoprostol for termination of first trimester missed abortion', 'description': 'Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses', 'interventionNames': ['Drug: Misoprostol Pill']}], 'interventions': [{'name': 'Misoprostol Pill', 'type': 'DRUG', 'description': 'sublingual versus vaginal Misoprostol in termination of first trimester missed abortion', 'armGroupLabels': ['Sublingual Misoprostol for termination of first trimester missed abortion', 'Vaginal Misoprostol for termination of first trimester missed abortion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Emam', 'role': 'CONTACT', 'email': 'emam3882@gmail.com', 'phone': '01003304781'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in obstetrics and gynecology', 'investigatorFullName': 'Ahmed Mahmoud Emam Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}