Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-05 @ 8:31 AM
Study NCT ID:
NCT04215835
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'induction to abortion time', 'timeFrame': '6 hours', 'description': 'induction to abortion time'}, {'measure': 'Incidence of complete miscarriage', 'timeFrame': '6 hours', 'description': 'Incidence of complete miscarriage'}], 'secondaryOutcomes': [{'measure': 'Need for surgical evacuation of the products of conception', 'timeFrame': '6 hours', 'description': 'Need for surgical evacuation of the products of conception'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Missed Abortion']}, 'descriptionModule': {'briefSummary': 'This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age less than 64 days gestation (\\<9 wks).\n* Hemoglobin \\>10 g/dL.\n* BMI between 18.5 kg/m2 and 25 kg/m2.\n* Missed abortion.\n* previous one or more cesarean delivaries\n\nExclusion Criteria:\n\n* Molar pregnancy.\n* Fibroid uterus.\n* Uterine anomalies.\n* Coagulopathy.\n* Medical disorder that contraindicate induction of abortion (e.g. heart failure).\n* Previous attempts for induction of abortion in the current pregnancy.\n* Allergy to misoprostol or letrozole.'}, 'identificationModule': {'nctId': 'NCT04215835', 'briefTitle': 'Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'letrozole pretreatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': '3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.', 'interventionNames': ['Drug: letrozole then misoprostol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses', 'interventionNames': ['Drug: placebo then misoprostol']}], 'interventions': [{'name': 'letrozole then misoprostol', 'type': 'DRUG', 'description': 'Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days\n\nDrug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion', 'armGroupLabels': ['study group']}, {'name': 'placebo then misoprostol', 'type': 'DRUG', 'description': 'Drug: Placebo placebo for 3 days\n\nDrug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AHMED SAMY', 'role': 'CONTACT', 'email': 'ahmedsamy8233@gmail.com', 'phone': '+201100681167'}], 'overallOfficials': [{'name': 'AHMED SAMY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor obstetrics and gynecology', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}