Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT02950935
Status:
TERMINATED
Last Update Posted:
2018-07-20
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progesterone in Threatened Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Difficulty in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate at 12 weeks of gestation', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction of the frequency of uterine contractions;', 'timeFrame': '15 days'}, {'measure': 'Pain reduction (using a Numerical Rating Scale);', 'timeFrame': '15 days'}, {'measure': 'Reduction of subchorionic haematoma;', 'timeFrame': '15 days', 'description': 'Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.'}, {'measure': 'Number of subjects with onset of new threatened abortion', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Threatened Abortion in First Trimester']}, 'descriptionModule': {'briefSummary': 'The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women attending the emergency room of the study sites with the following characteristics:\n* Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule;\n* Age: 18-37 years;\n* BMI: 18-28 kg/m2;\n* Symptoms of threatened abortion (vaginal bleeding , with or without pelvic pain);\n* Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat);\n* Gestation week ≥6 weeks (5 w +1d) and \\<12 weeks (11 w + 1d) according to ultrasound dating (CRL);\n* Closed uterine cervix;\n* At the first case of threatened abortion in the current pregnancy.\n\nExclusion Criteria:\n\n* Pregnancy obtained via ART treatment;\n* Subchorionic haematoma with \\>50% placental detachment;\n* History of recurrent miscarriage;\n* Severe uterine malformations;\n* Known hypersensitivity to study medication;\n* Neoplasias (known or suspected breast or genital tract cancer);\n* Severe impairment of hepatic or renal function;\n* Use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility);\n* Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;\n* Porphyria;\n* A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;\n* Antiphospholipid syndrome;\n* Diabetes mellitus;\n* Known thyroid diseases or autoimmune conditions.'}, 'identificationModule': {'nctId': 'NCT02950935', 'briefTitle': 'Progesterone in Threatened Abortion', 'organization': {'class': 'INDUSTRY', 'fullName': 'IBSA Institut Biochimique SA'}, 'officialTitle': 'Prospective, Double-blind, Randomised, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of Natural Progesterone 25 mg/Bid Administered Subcutaneously in the Maintenance of Early Pregnancy in Women With Symptoms of Threatened Abortion', 'orgStudyIdInfo': {'id': '16I-Prg06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progesterone', 'description': '25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.', 'interventionNames': ['Drug: Progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo will be administered twice à day until the 12th week of gestation.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'description': 'subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.', 'armGroupLabels': ['Progesterone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70021', 'city': 'Bari', 'state': 'BA', 'country': 'Italy', 'facility': '"F. Miulli" Regional General Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'P.O.G. Salesi', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Cattolica', 'country': 'Italy', 'facility': 'Ospedale Cervesi', 'geoPoint': {'lat': 43.96182, 'lon': 12.73631}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': "Presidio Ospedale S'Anna", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IBSA Institut Biochimique SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}