Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-24 @ 2:30 PM
Study NCT ID:
NCT02405156
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of induction of abortion', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'The incidence of need for surgical evacuation of placenta.', 'timeFrame': '24 hours'}, {'measure': 'Hemoglobin change', 'timeFrame': '24 hours'}, {'measure': 'Maternal morbidity', 'timeFrame': '24 hours'}, {'measure': 'Success of induction of abortion', 'timeFrame': '24 hours', 'description': 'number of participants with Success of induction of abortion'}, {'measure': 'Hematocrit change', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Letrozole', 'misoprostol', 'second trimester miscarriage'], 'conditions': ['Miscarriage']}, 'descriptionModule': {'briefSummary': 'To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.', 'detailedDescription': 'This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.\n\nPatients fulfilling inclusion and exclusion criteria will be divided into two groups.\n\nGroup (A):\n\n181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.\n\nGroup (B):\n\n181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.\n\nData recording:\n\n1. Duration of complete abortion.\n2. Post abortion bleeding.\n3. Incomplete delivery of the placenta necessitates evacuation under anesthesia.\n4. Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.\n5. Recording maternal morbidities.\n6. Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age more than 18 years old (age of legal consent).\n* Gestational age between 12 weeks and 24 weeks.\n* Hemoglobin \\>10 g/dL.\n* BMI between 25 kg/m2 and 35 kg/m2.\n* Miscarriage .\n* Living fetus with multiple congenital malformations incompatible with life.\n* PPROMs with drained liquor and parents are consenting for termination of pregnancy.\n\nExclusion Criteria:\n\n* Maternal age less than 18 years old.\n* Gestational age less than 12 weeks or more than 24 weeks.\n* Hemoglobin \\<10 g/dL.\n* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).\n* Polyhydraminos.\n* Anencephaly.\n* Fibroid uterus.\n* BMI less than 25kg/m2 and more than 35kg/m2.\n* Coagulopathy.\n* History or evidence of adrenal pathology.\n* Previous attempts for induction of abortion in the current pregnancy.'}, 'identificationModule': {'nctId': 'NCT02405156', 'briefTitle': 'Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion', 'orgStudyIdInfo': {'id': '305172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'letrozole + misoprostol', 'description': 'Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.', 'interventionNames': ['Drug: Letrozole', 'Drug: Misoprostol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + misoprostol', 'description': 'Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.', 'interventionNames': ['Drug: Placebo', 'Drug: Misoprostol']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['femara'], 'armGroupLabels': ['letrozole + misoprostol']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo + misoprostol']}, {'name': 'Misoprostol', 'type': 'DRUG', 'armGroupLabels': ['letrozole + misoprostol', 'placebo + misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mostafa Gomaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Ihab Serag-ElDin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Gasser El-Bishry, FRCOG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Ahmed Swidan, M.B.B.ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mohamed S. Sweed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mohamed Samir Sweed', 'investigatorFullName': 'Mohamed S Sweed, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}