Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-04 @ 5:54 PM
Study NCT ID:
NCT04753957
Status:
TERMINATED
Last Update Posted:
2022-05-26
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Progesterone in Pregnancy-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial (ng/mg) progesterone time/concentration profile', 'timeFrame': '12 hours', 'description': 'Concentration of progesterone in endometrium, sampled at time of scheduled c-section'}, {'measure': 'Plasma (ng/ml) progesterone time/concentration profile', 'timeFrame': '12 hours', 'description': 'concentration of serum progesterone, sampled at time of scheduled c-section'}], 'secondaryOutcomes': [{'measure': 'Side effect survey', 'timeFrame': '24hr after delivery', 'description': 'survey of side effects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.', 'detailedDescription': 'The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18yo\n* Singleton gestation, ≥36 0/7 weeks gestation\n* Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate\n\nExclusion Criteria:\n\n* Contraindication to vaginal progesterone suppository\n\n * Active hepatic disease\n * Prior or current thrombus\n * Known adverse reaction to progesterone\n * Peanut allergy\n* Bleeding disorder (such as thrombophilia)\n* Use of 17-hydroxyprogesterone caproate in the pregnancy\n* Use of vaginal progesterone in the pregnancy\n* History of adverse reaction to progesterone\n* Current vaginitis'}, 'identificationModule': {'nctId': 'NCT04753957', 'acronym': 'PiP-2', 'briefTitle': 'Pharmacokinetics of Progesterone in Pregnancy-2', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Pharmacokinetics of Progesterone in Pregnancy-2', 'orgStudyIdInfo': {'id': '20D.1094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal progesterone', 'description': '200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery', 'interventionNames': ['Drug: micronized Progesterone']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention, scheduled cesarean delivery'}], 'interventions': [{'name': 'micronized Progesterone', 'type': 'DRUG', 'description': '200mg micronized progesterone placed vaginally', 'armGroupLabels': ['Vaginal progesterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Following trial completion and publication', 'ipdSharing': 'YES', 'description': 'IPD may be requested following trial completion and publication with appropriate data sharing agreement.', 'accessCriteria': 'Data sharing agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}