Viewing Study NCT00615550

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Ignite Creation Date: 2025-12-24 @ 5:02 PM
Ignite Modification Date: 2026-02-27 @ 1:08 AM
Study NCT ID: NCT00615550
Status: COMPLETED
Last Update Posted: 2012-03-13
First Post: 2008-01-18
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: PREGNANT Short Cervix Trial
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gcreasy@columbialabs.com', 'phone': '973-486-8797', 'title': 'George W Creasy MD', 'organization': 'Columbia Laboratories'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Trial not powered for subgroup analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Randomization to delivery (1 day to 168 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'placebo vaginal gel', 'otherNumAtRisk': 223, 'otherNumAffected': 24, 'seriousNumAtRisk': 224, 'seriousNumAffected': 98}, {'id': 'EG001', 'title': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel', 'otherNumAtRisk': 235, 'otherNumAffected': 30, 'seriousNumAtRisk': 235, 'seriousNumAffected': 97}], 'otherEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bleeding peripartum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cervix disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'chorioamnionitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'premature rupture of membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'foetal growth retardation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 44, 'numAffected': 44}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'premature labor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'premature rupture of the membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cervix disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'uterine contractions abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'foetal distress abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cervical incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'chorioamnionitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'foetal growth retardation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pregnancy induced hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'foetal heart rate deceleration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'intra-uterine death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'funisitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'oligohydramnios', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HELLP syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'postpartum haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'bradycardia foetal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'breech presentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cholestasis of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'foetal movements decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'obstructed labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'placenta accreta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'tachycardia foetal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'umbilical cord prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'vomiting in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'uterine pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cervix cerclage procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'maternal therapy to enhance foetal lung maturity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ureaplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'abdominal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cholecysitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'feotal monitoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'physical assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Birth <=32 6/7 Weeks Gestation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo vaginal gel'}, {'id': 'OG001', 'title': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 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'0.048', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Statistical analysis presented for composite score data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.92', 'groupDescription': 'Statistical analysis presented for RDS data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery Hospitalization (1-212 days)', 'description': 'Each infant is scored based on the 7 morbidity and mortality events above:\n\n0= no morbidity event\n\n1. 1 morbidity event\n2. 2 morbidity events\n3. 3 or more morbidity events\n4. mortality', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo vaginal gel'}, {'id': 'OG001', 'title': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel'}], 'classes': [{'title': 'Number of deliveries <= 27 6/7 weeks', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Number of deliveries <= 34 6/7 weeks', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Number of deliveries <= 36 weeks', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 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'groupDescription': 'Statistical analysis presented for \\<36 weeks data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Gestational Age at Delivery', 'description': 'Number of participants at \\<=27 6/7 , \\<=34 6/7, and \\<36 6/7.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Number of Neonates Who Died.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo vaginal gel'}, {'id': 'OG001', 'title': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.431', 'groupIds': ['OG000', 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'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Birth weight < 2500 grams', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.85', 'groupDescription': 'Statistical analysis for birth weight \\< 1500 grams data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.11', 'groupDescription': 'Statistical analysis for birth weight \\< 2500 grams data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'date of delivery', 'description': 'Assessment of birth weight \\< 1500 grams or \\< 2500 grams', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Available birth weight.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'placebo vaginal gel'}, {'id': 'FG001', 'title': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'March 2008 to June 2010'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'placebo vaginal gel'}, {'id': 'BG001', 'title': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}, {'title': '>=65 years', 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Enrollment', 'classes': [{'title': 'Belarus', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 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'Assessment of birth weight \\< 1500 grams or \\< 2500 grams'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preterm', 'Cervix'], 'conditions': ['Preterm Delivery', 'Short Cervix', 'Short Uterine Cervical Length']}, 'referencesModule': {'references': [{'pmid': '17899572', 'type': 'BACKGROUND', 'citation': "O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96. doi: 10.1002/uog.5158."}, {'pmid': '17899571', 'type': 'BACKGROUND', 'citation': "DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159."}, {'pmid': '17671254', 'type': 'BACKGROUND', 'citation': 'Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.'}, {'pmid': '17899585', 'type': 'BACKGROUND', 'citation': 'Romero R. Prevention of spontaneous preterm birth: the role of sonographic cervical length in identifying patients who may benefit from progesterone treatment. Ultrasound Obstet Gynecol. 2007 Oct;30(5):675-86. doi: 10.1002/uog.5174. No abstract available.'}, {'pmid': '21472815', 'type': 'RESULT', 'citation': "Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15."}, {'pmid': '22284156', 'type': 'RESULT', 'citation': "Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11."}], 'seeAlsoLinks': [{'url': 'http://onlinelibrary.wiley.com/doi/10.1002/uog.9017/pdf', 'label': 'Ultrasound Obstet Gynecol (2011)'}, {'url': 'http://onlinelibrary.wiley.com/doi/10.1002/uog.9017/pdf', 'label': 'Open Access to Final Study Result Publication'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.', 'detailedDescription': 'A Short uterine cervical length in the mid-trimester is the most powerful predictor of preterm birth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject has a short cervical length by transvaginal ultrasound (TVU) defined as 10-20mm. In cases of "dynamic cervix", the shortest observed/documented cervical length by TVU is to be used as the cervical length for inclusion purposes.\n2. Singleton gestation.\n3. The pregnancy has an estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.\n4. Maternal age between 15 (or local age of majority/emancipation) and 45 years of age at the time of screening. An alternative age range can be accepted according to the standards and applicable regulations of the study centers.\n5. The subject speaks either English or a common local language.\n6. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.\n7. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.\n\nExclusion Criteria:\n\n1. The subject has a cervical length \\<10 or \\>20mm.\n2. The subject has a multifetal gestation.\n3. The subject has or is scheduled to have a cervical cerclage prior to randomization. According to ACOG Practice Bulletin Number 48 (November 2003), cerclage can be considered in a subject with a history of 3 or more unexplained midtrimester pregnancy losses or preterm deliveries.228,229\n4. Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.\n5. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.\n6. The subject has been treated with a progestogen within the previous 4 weeks.\n7. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).\n8. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.\n9. The subject has active liver dysfunction or disease.\n10. The subject has known or suspected malignancy of the breast or genital organs.\n11. The subject is currently participating in another interventional study or has participated in an interventional drug study within one month prior to screening for this study.\n12. The subject\'s current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.\n13. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)\n14. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures.\n15. The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment.\n16. The subject is HIV positive with a CD4 count of \\<350 cells/mm3 and is receiving more than one (1) medication to prevent the transfer of AIDS to the fetus.\n17. Complete placenta previa.'}, 'identificationModule': {'nctId': 'NCT00615550', 'briefTitle': 'PREGNANT Short Cervix Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Juniper Pharmaceuticals, Inc.'}, 'officialTitle': 'The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)]', 'orgStudyIdInfo': {'id': 'COL-1620-302'}, 'secondaryIdInfos': [{'id': '09-CH-N014'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo vaginal gel', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prochieve', 'description': 'Progesterone 8% Vaginal Gel', 'interventionNames': ['Drug: progesterone']}], 'interventions': [{'name': 'progesterone', 'type': 'DRUG', 'otherNames': ['Prochieve 8%'], 'description': '8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation', 'armGroupLabels': ['Prochieve']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Dept. of OB/GYN', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Med Ctr Women's Care Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCI Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90502', 'city': 'Torrance', 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