Viewing Study NCT02059135

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 10:36 PM
Ignite Modification Date: 2025-12-29 @ 12:32 PM
Study NCT ID: NCT02059135
Status: COMPLETED
Last Update Posted: 2017-08-09
First Post: 2014-02-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
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': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.massey@lfb-usa.com', 'phone': '508-370-5157', 'title': 'Laura Massey, Sr. Clinical Project Manager', 'organization': 'LFB USA'}, 'certainAgreement': {'otherDetails': "The site may publish the results of the study after the multi-center publication or 18 months after the sponsor's final evaluation of all study data from all sites, whichever occurs first.\n\nUp to 90 days prior to submitting a manuscript or prior to any public presentation, a copy of the abstract, manuscript, or presentation will be provided to Sponsor by the Site for review and comment. Sponsor shall have said 90 day period to respond to the Site with comments.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Note: 6 subjects (2 in the Recombinant Human Antithrombin (ATryn) group and 4 in the placebo group) were randomized but received no treatment. These subjects are included in the ITT population but not the maternal safety population.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery).', 'description': 'Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'Maternal/Fetal Safety Population: ATryn', 'description': 'Subjects treated with Recombinant human antithrombin (ATryn):\n\nATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 60, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%)', 'description': 'Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 53, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Neonatal Safety Population: ATryn', 'description': 'Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 3, 'seriousNumAffected': 32}, {'id': 'EG003', 'title': 'Neonatal Safety Population: Placebo', 'description': 'Neonates born to mothers treated with placebo (Normal Saline 0.9%)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 2, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Postpartum depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal Wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'HELLP syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intrapartum haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Postpartum haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypospadias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Persistent foetal circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neonatal intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meningitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Periventricular leukomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Small for dates baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory tract haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nonreassuring foetal heart rate pattern', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Foetal growth restriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Increase in Gestational Age in Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Antithrombin (ATryn)', 'description': 'ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days\n\nRecombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days'}, {'id': 'OG001', 'title': 'Normal Saline 0.9%', 'description': 'Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.\n\nNormal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.', 'description': 'Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Antithrombin (ATryn)', 'description': 'ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days\n\nRecombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days'}, {'id': 'OG001', 'title': 'Normal Saline 0.9%', 'description': 'Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.\n\nNormal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)', 'description': 'Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once.\n\nScore Outcome 0 No events, no mortality\n\n1. One event, no mortality\n2. Two events, no mortality\n3. Three or more events, no mortality\n4. Death', 'unitOfMeasure': 'scores on a scale of 0 to 4', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Antithrombin (ATryn)', 'description': 'ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days\n\nRecombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days'}, {'id': 'OG001', 'title': 'Normal Saline 0.9%', 'description': 'Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.\n\nNormal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%'}], 'classes': [{'title': 'Maternal Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Eclamptic Seizure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Myocardial Infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Cerebrovascular Accident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Transient Ischemic Attack', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Progressive Renal Insufficiency', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Thrombocytopenia (without HELLP)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Maternal HELLP', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal DIC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Pulmonary Edema', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Placental Abruption', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal Severe Intra and Post-Partum Hemorrhage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maternal VTE Including DVT and Pulmonary Embolism', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fetal Death (including stillbirth)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fetal and neonatal death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Small for Gestational Age (SGA) <10%', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Respiratory Distress Syndrom (RDS)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Bronchopulmonary Dysplasia (BPD)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Retinopathy of Prematurity stage >= 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "Neonatal Necrotizing Enterocolitis-Bell's gr >= 2", 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Intraventricular Hemorrhage gr >= 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Cystic Periventricular Leucomalacia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Early Sepsis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Late Sepsis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal Meningitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avoidance of neonatal morbidity and mortality', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery).', 'description': "Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs \\<28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity \\[BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell's stage ≥ 2)\\].", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Recombinant Human Antithrombin (ATryn)', 'description': 'ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days\n\nRecombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days'}, {'id': 'FG001', 'title': 'Normal Saline 0.9%', 'description': 'Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.\n\nNormal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%'}], 'periods': [{'title': 'Maternal Follow-up (ITT Population)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'declined to see site staff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "didn't return to site (f/u elsewhere)", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Neonatal Follow-up (Safety Population)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'delivered at another hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Recombinant Human Antithrombin (ATryn)', 'description': 'ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days\n\nRecombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days'}, {'id': 'BG001', 'title': 'Normal Saline 0.9%', 'description': 'Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.\n\nNormal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '27.18', 'spread': '1.96', 'groupId': 'BG000'}, {'value': '27.34', 'spread': '2.06', 'groupId': 'BG001'}, {'value': '27.25', 'spread': '2.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type of Preeclampsia', 'classes': [{'categories': [{'title': 'Preeclampsia', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Superimposed Preeclampsia', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity (number of previous live births)', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT Population'}}, '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': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2014-02-06', 'resultsFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-11', 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality', 'timeFrame': 'Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery).', 'description': "Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs \\<28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity \\[BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell's stage ≥ 2)\\]."}], 'primaryOutcomes': [{'measure': 'Increase in Gestational Age in Days', 'timeFrame': 'Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.', 'description': 'Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.'}], 'secondaryOutcomes': [{'measure': 'Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)', 'timeFrame': 'Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)', 'description': 'Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once.\n\nScore Outcome 0 No events, no mortality\n\n1. One event, no mortality\n2. Two events, no mortality\n3. Three or more events, no mortality\n4. Death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preeclampsia', 'Preterm preeclampsia', 'Pregnancy'], 'conditions': ['Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '32780999', 'type': 'DERIVED', 'citation': 'Paidas MJ, Tita ATN, Macones GA, Saade GA, Ehrenkranz RA, Triche EW, Streisand JB, Lam GK, Magann EF, Lewis DF, Dombrowski MP, Werner EF, Branch DW, Habli MA, Grotegut CA, Silver RM, Longo SA, Amon E, Cleary KL, How HY, Novotny SR, Grobman WA, Whiteman VE, Wing DA, Scifres CM, Sibai BM. Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia. Am J Obstet Gynecol. 2020 Nov;223(5):739.e1-739.e13. doi: 10.1016/j.ajog.2020.08.004. Epub 2020 Aug 8.'}, {'pmid': '26886785', 'type': 'DERIVED', 'citation': 'Cotten CM. Adverse consequences of neonatal antibiotic exposure. Curr Opin Pediatr. 2016 Apr;28(2):141-9. doi: 10.1097/MOP.0000000000000338.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy, safety and pharmacokinetics (PK) of recombinant human antithrombin (ATryn) in addition to expectant management for the treatment of preterm preeclampsia (PPE). Efficacy will be assessed by comparing the difference in extension of gestational age from the time of randomization into the study until delivery between ATryn and placebo treated subjects. In addition, the effect of ATryn on fetal and neonatal clinical outcomes will be assessed. The PK characteristics of ATryn in the subjects will be investigated by measuring AT activity levels in the mother during treatment and in cord blood.', 'detailedDescription': "Hospitalized PPE patients who are being expectantly managed, after initial assessment and stabilization period, will be considered for the study. After informed consent has been obtained subjects will be screened for eligibility. Screening includes obtaining the subject's medical/obstetric history and a physical examination which includes an assessment of maternal and fetal status. Blood samples for hematology, clinical chemistries, biomarkers, coagulation, immunogenicity and AT activity levels will be drawn. Urine will be collected for baseline urinalysis, protein/creatinine ratio and biomarkers. Eligible subjects who meet inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive a continuous infusion of either ATryn or placebo.\n\nSampling for AT activity will be performed immediately prior to the first dose of study drug and at specified times thereafter.\n\nSubjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation. The average extension of pregnancy with standard of care expectant management in this patient population is approximately 7 days. It is assumed that treatment with ATryn will provide an additional increase in gestational age of 5-7 days as compared to this standard of care. Total duration on study drug is therefore estimated to be approximately 7 to 14 days on average.\n\nPost treatment assessments of the mother will be performed at hospital discharge and approximately 4-6 weeks after delivery of the neonate. Information on the neonates will be collected until they reach a post-menstrual age (PMA) of 36 weeks. If the neonate reaches 36 weeks PMA \\< 28 days following delivery, the final neonatal follow-up visit should be done at the 4-6 week post-delivery visit.\n\nAfter the primary study completion and follow-up period, the neonate total number of days in the Neonatal Intensive Care Unit (NICU), days on a ventilator, days requiring supplemental oxygen (FiO2 ≥21%),the neonate hospital discharge date and whether the neonate is discharged from the hospital with a requirement for supplemental home oxygen therapy will be collected to help assess health care utilization. In addition, the date of death will be collected if the neonate expires before hospital discharge. These data will be considered supplemental to the primary study data set."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized female pregnant patients of gestational age of ≥23 0/7 weeks to ≤30 0/7 weeks (for subjects at gestational age 23 0/7 to 23 6/7 all standard interventions including antenatal steroids and cesarean for fetal indications must be offered).\n\n Gestational age determination by local practice using one of the following three approaches:\n * Last menstrual period (LMP) dating and confirmatory ultrasound\n * Ultrasound alone when LMP is not reliable\n * Known date of conception in the setting of assisted reproductive technology\n2. At least 16 years of age (NOTE: different age restrictions may apply per local regulation and/or ethical considerations; subjects under the local age of consent may be excluded at the discretion of the reviewing Institutional Review Board (IRB)\n3. Recent diagnosis of Preeclampsia or Superimposed Preeclampsia as defined by:\n\n • For Preeclampsia\n * Gestational hypertension defined as a recorded systolic blood pressure (BP) of\n\n ≥140 mm Hg or diastolic BP of ≥90 mm Hg on 2 occasions at least 4 hours apart (since the commencement of medical intervention in any facility) OR\n * Severe gestational hypertension defined as systolic blood pressure of ≥ 160 mm Hg or diastolic blood pressure ≥ 110 mm Hg, confirmed with second assessment within a short interval (minutes) AND\n * New onset of any of the following:\n\n * Proteinuria defined as ≥0.3 g protein per 24 hours in a 12-24 hour urine collection or protein/creatinine ratio of ≥0.3 mg/mg\\* (on a random sample or any collection period.)\n * Platelet count less than 100,000/μL\n * Serum creatinine concentrations greater than 1.1 mg/dL in the absence of other renal disease\n * Elevated liver transaminases to ≥ twice upper limit of normal\n * Cerebral or visual symptoms\n\n For Superimposed preeclampsia:\n * The start of antihypertensive medication, increasing the dose of a currently administered antihypertensive medication or adding a second antihypertensive medication after 20 weeks of pregnancy for systolic BP ≥ 160 or diastolic BP ≥ 105 in a patient that had a previous history of controlled hypertension before 20 weeks of pregnancy. AND\n * New onset of any of the following:\n\n * proteinuria defined as ≥0.3 g protein per 24 hours in a 12-24 hour urine collection or protein/creatinine ratio of ≥0.3 mg/mg (on a random sample or any collection period)\n * Platelet count less than 100,000/μL\n * Serum creatinine concentrations greater than 1.1 mg/dL in the absence of other renal disease\n * Elevated liver transaminases to ≥ twice upper limit of normal\n * Cerebral or visual symptoms\n4. In the opinion of the investigator the patient has demonstrated sufficient clinical stability to be eligible for expectant management\n5. The patient is expected to be managed as an inpatient until delivery\n6. Signed informed consent for both subject and neonate\n\nExclusion Criteria:\n\n1. Criteria that would likely require immediate delivery of the fetus are exclusionary if present just prior to randomization:\n\n * Refractory hypertension despite maximal medical intervention of systolic BP ≥160 mm Hg or diastolic BP of ≥110 mm Hg\n * Thrombocytopenia (platelets ˂ 100/mm3) with or without Hemolysis elevated liver enzymes low platelets (HELLP) syndrome defined as defined as Aspartate amino transferase (AST) ≥70 units/L, and platelets ˂100/mm3, and evidence of hemolysis on blood film plus either Lactic dehydrogenase (LDH) ≥600 IU/mL or total bilirubin ≥1.2 mg/dL)\n * Oliguria (≤500 mL/24 hours) or evidence of progressive renal insufficiency\n * Serum creatinine concentration greater than 1.1 mg/dL\n * Persistent visual disturbances\n * Placental abruption\n * Pulmonary edema\n * Nonreassuring fetal heart rate tracing\n * Intractable headache unrelieved with analgesia\n * Intractable right upper quadrant abdominal pain or vomiting\n * If umbilical Doppler ultrasound has been performed, the presence of an abnormal umbilical artery Doppler as defined by absent or reverse end diastolic flow\n * Biophysical score ≤ 4/10 on 2 occasions\n * Oligohydramnios (deepest vertical pocket less than 2 x 2cm on ultrasound)\n * Other maternal or fetal conditions that would preclude expectant management\n2. Known lethal or major fetal anomaly\n3. Recent (within 12 months) history of maternal alcoholism or drug dependence\n4. Diagnosis of epilepsy\n5. Has need for chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase (Cox)-2 inhibitors, or unwilling to abstain from use of NSAIDs during the study treatment period (low dose aspirin of 81 mg/day or less allowable)\n6. Received within 72 hours or has requirement for heparin; low molecular weight heparins such as enoxaparin or dalteparin; fondaparinux; antiplatelet agents such as clopidogrel, prasugrel, or high dose aspirin (\\>81 mg/day); Direct Thrombin Inhibitors (DTI) such as dabigatran\n7. Pre-existing renal disease, documented pre-pregnancy or in pregnancy prior to 20 weeks gestation (prior to the diagnosis of preeclampsia) or 24 hr urine of ≥0.3 gm/24 hours, documented in pregnancy, prior to 20 weeks gestation or ≥2+ dipstick or ≥ 0.3 Protein Creatinine Ratio (PCR), documented in pregnancy at the last available test prior to 20 weeks gestation. In the case of conflicting results between dipstick, PCR, and timed urine collection tests to work up an episode of proteinuria, the timed urine collection result would supersede other results\n8. Multi-fetal pregnancy\n9. History of Antiphospholipid antibody syndrome\n10. Known hypersensitivity to goat and goat milk proteins\n11. Participation in another interventional clinical trial of an investigational, unapproved therapy (drug, biologic, device) within 30 days of consent'}, 'identificationModule': {'nctId': 'NCT02059135', 'acronym': 'PRESERVE-1', 'briefTitle': 'Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia', 'organization': {'class': 'INDUSTRY', 'fullName': 'rEVO Biologics'}, 'officialTitle': 'Prospective Randomized Double-Blind, Placebo Controlled Evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia (PRESERVE-1)', 'orgStudyIdInfo': {'id': 'RB AT PPE 01-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant Human Antithrombin (ATryn)', 'description': 'ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days', 'interventionNames': ['Biological: Recombinant human antithrombin (ATryn)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline 0.9%', 'description': 'Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.', 'interventionNames': ['Other: Normal Saline 0.9%']}], 'interventions': [{'name': 'Recombinant human antithrombin (ATryn)', 'type': 'BIOLOGICAL', 'otherNames': ['Recombinant human antithrombin (rhAT)'], 'description': 'Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days', 'armGroupLabels': ['Recombinant Human Antithrombin (ATryn)']}, {'name': 'Normal Saline 0.9%', 'type': 'OTHER', 'otherNames': ['Normal Saline'], 'description': 'Placebo Comparator: Normal Saline 0.9%', 'armGroupLabels': ['Normal Saline 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35210', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Oschner Baptist', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint John Hospital and Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '32916', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45211', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Tri-State Maternal Fetal Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women & Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '347403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Medical Center', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Houston School of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Health', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospitals & Clinics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Michael Paidas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale New Haven Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'rEVO Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}