Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-21 @ 6:10 AM
Study NCT ID:
NCT02782559
Status:
WITHDRAWN
Last Update Posted:
2018-03-27
First Post:
2016-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sildenafil in Preterm Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'difficulties acquiring the drug and funding for the drug', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2016-02-11', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency (duration of pregnancy from diagnosis/randomization until delivery)', 'timeFrame': 'Diagnosis (randomization) until delivery, up to 34 weeks)', 'description': 'earliest randomization can occur at 24 weeks gestation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preterm Preeclampsia']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia', 'detailedDescription': 'Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks.\n2. Dating of pregnancy by ultrasound \\< or equal to 22 weeks or IVF conception\n3. Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia\n\nExclusion Criteria:\n\n1. Need for immediate delivery of the fetus\n2. Known lethal anomaly\n3. Pre-existing renal disease\n4. Hypersensitivity to sildenafil\n5. Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs\n6. Active peptic ulcer disease\n7. Undergoing nitrate therapy'}, 'identificationModule': {'nctId': 'NCT02782559', 'acronym': 'SIL', 'briefTitle': 'Efficacy of Sildenafil in Preterm Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia', 'orgStudyIdInfo': {'id': 'HSC-MS-16-0083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil', 'description': 'Sildenafil 40mg oral tablet three times a day from randomization until delivery', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched to oral capsule of active treatment three times a day from randomization until delivery', 'interventionNames': ['Drug: Sildenafil', 'Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Sildenafil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Color and size matched to active drug (sildenafil)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robyn P Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}