Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-25 @ 1:48 AM
Study NCT ID:
NCT02990403
Status:
UNKNOWN
Last Update Posted:
2017-03-08
First Post:
2016-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D004394', 'term': 'Dydrogesterone'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'live birth means success pregnancy（more than gestational age of 20 weeks）'}], 'secondaryOutcomes': [{'measure': 'D-dimer', 'timeFrame': 'through study completion, an average of 3 year'}, {'measure': 'Uterine artery blood flow', 'timeFrame': 'through study completion, an average of 3 year'}, {'measure': 'human chorionic gonadotropin', 'timeFrame': 'through study completion, an average of 3 year'}]}, 'conditionsModule': {'conditions': ['Recurrent Pregnancy Loss']}, 'descriptionModule': {'briefSummary': 'In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a prospective randomized controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Woman who had 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.\n\nExclusion Criteria:\n\n1. having experienced severe allergies, trauma history and/or operation history within 3 months.\n2. with a history of mental illness and/or family history of mental illness limb disabled.\n3. taking medicine within one month.\n4. suffering major events or having mood swings.\n5. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)\n6. chromosome aberrations in anyone of the couple.\n7. patients who have drugs contraindications'}, 'identificationModule': {'nctId': 'NCT02990403', 'briefTitle': 'The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss', 'orgStudyIdInfo': {'id': 'ShanghaiFMIH-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aspirin+LMWH group', 'description': 'aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd', 'interventionNames': ['Drug: Aspirin', 'Drug: Heparin']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin+LMWH+immunoglobulin group', 'description': 'aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks', 'interventionNames': ['Drug: Aspirin', 'Drug: Heparin', 'Drug: Immunoglobulin']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin+LMWH+prednisone group', 'description': 'aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd', 'interventionNames': ['Drug: Aspirin', 'Drug: Heparin', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin+LMWH+IVIG+prednisone group', 'description': 'aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd', 'interventionNames': ['Drug: Aspirin', 'Drug: Heparin', 'Drug: Prednisone', 'Drug: Immunoglobulin']}, {'type': 'OTHER', 'label': 'dydrogesterone group', 'description': 'dydrogesterone 20-30mg/day, po, tid', 'interventionNames': ['Drug: Dydrogesterone']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'armGroupLabels': ['aspirin+LMWH group', 'aspirin+LMWH+IVIG+prednisone group', 'aspirin+LMWH+immunoglobulin group', 'aspirin+LMWH+prednisone group']}, {'name': 'Heparin', 'type': 'DRUG', 'armGroupLabels': ['aspirin+LMWH group', 'aspirin+LMWH+IVIG+prednisone group', 'aspirin+LMWH+immunoglobulin group', 'aspirin+LMWH+prednisone group']}, {'name': 'Prednisone', 'type': 'DRUG', 'armGroupLabels': ['aspirin+LMWH+IVIG+prednisone group', 'aspirin+LMWH+prednisone group']}, {'name': 'Immunoglobulin', 'type': 'DRUG', 'armGroupLabels': ['aspirin+LMWH+IVIG+prednisone group', 'aspirin+LMWH+immunoglobulin group']}, {'name': 'Dydrogesterone', 'type': 'DRUG', 'armGroupLabels': ['dydrogesterone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200051', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shihua Bao, PhD', 'role': 'CONTACT', 'email': 'baoshihua@tongji.edu.cn', 'phone': '86-21-20261430', 'phoneExt': '2012'}, {'name': 'Yan Yan, Master', 'role': 'CONTACT', 'email': 'shtjyanyan@163.com', 'phone': '86-21-20261430', 'phoneExt': '2012'}, {'name': 'Shihua Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yan Yan, master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai first Maternity and Infant health hospital, Tong Ji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shihua Bao', 'investigatorAffiliation': 'Shanghai First Maternity and Infant Hospital'}}}}