Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
Study NCT ID:
NCT02913495
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2016-09-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-28', 'releaseDate': '2023-06-06'}, {'resetDate': '2025-11-25', 'releaseDate': '2025-11-25'}], 'estimatedResultsFirstSubmitDate': '2023-06-06'}}, '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'}, {'id': 'D000077713', 'term': '17 alpha-Hydroxyprogesterone Caproate'}], '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'}, {'id': 'D019326', 'term': '17-alpha-Hydroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm birth <37 weeks', 'timeFrame': 'up to 9 months (delivery)', 'description': 'Incidence of gestational age of delivery less than 37 weeks'}], 'secondaryOutcomes': [{'measure': 'Gestational age of delivery', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Preterm birth <34 weeks and <28 weeks', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Second trimester cervical length <25mm', 'timeFrame': '2 months'}, {'measure': 'Mode of delivery', 'timeFrame': 'up to 9 months (delivery)', 'description': 'Delivery mode- vaginal, cesarean, operative vaginal'}, {'measure': 'Maternal mortality', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': '5 minute Apgar score', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Neonatal intensive care unit admission', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Composite neonatal morbidity', 'timeFrame': 'up to 9 months (delivery)', 'description': '(respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, and perinatal mortality up to 28 days of life)'}, {'measure': 'Birthweight', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Perinatal mortality up to 28 days of life', 'timeFrame': 'up to 10 months (4 weeks after delivery)'}, {'measure': 'Medication side effects', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Satisfaction with medication (5 point Likert scale)', 'timeFrame': 'up to 9 months (delivery)'}, {'measure': 'Medication adherence', 'timeFrame': 'up to 9 months (delivery)', 'description': 'Vaginal progesterone:\n\n* Overall adherence: #days used/#days of treatment x 100\n* Non-adherent: ≥4 days between doses\n\nIntramuscular progesterone:\n\n* Overall adherence: #weeks used/#weeks of treatment x 100\n* Non-adherent: ≥10 days between doses'}, {'measure': 'Planned subgroup analysis for the outcome preterm birth <37 weeks, <34 weeks, <28 weeks', 'timeFrame': 'up to 9 months (delivery)', 'description': 'Planned subgroup analysis for the primary outcome as well as the secondary outcomes of preterm birth \\<34 weeks and \\<28 weeks of patients with a cervical length \\<25mm versus ≥25mm, history-indicated cerclage versus not, and for those started on progesterone 16-20 weeks versus 20-24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Progesterone', 'Prevention of preterm birth'], 'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '22996126', 'type': 'BACKGROUND', 'citation': 'Committee on Practice Bulletins-Obstetrics, The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012 Oct;120(4):964-73. doi: 10.1097/AOG.0b013e3182723b1b. No abstract available.'}, {'pmid': '27546354', 'type': 'BACKGROUND', 'citation': 'Saccone G, Khalifeh A, Elimian A, Bahrami E, Chaman-Ara K, Bahrami MA, Berghella V. Vaginal progesterone vs intramuscular 17alpha-hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Mar;49(3):315-321. doi: 10.1002/uog.17245. Epub 2017 Feb 6.'}, {'pmid': '35189093', 'type': 'DERIVED', 'citation': 'Boelig RC, Schoen CN, Frey H, Gimovsky AC, Springel E, Backley S, Berghella V. Vaginal progesterone vs intramuscular 17-hydroxyprogesterone caproate for prevention of recurrent preterm birth: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):722.e1-722.e12. doi: 10.1016/j.ajog.2022.02.012. Epub 2022 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.', 'detailedDescription': 'Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with singleton pregnancies\n* ≥18 years old\n* Estimated gestational age less than 24 0/7 weeks\n* Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.\n* Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.\n\nExclusion Criteria:\n\n* History of an adverse reaction to progesterone;\n* A contraindication to progesterone treatment;\n* Placenta previa or accreta;\n* Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;\n* Multifetal gestation;\n* Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT02913495', 'acronym': 'VIP', 'briefTitle': 'Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth', 'orgStudyIdInfo': {'id': '16D.542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal Progesterone', 'description': "200mg micronized progesterone vaginally, to be taken daily starting at 16 0/7 - 23 6/7 weeks, and continued daily until 36 6/7 weeks' gestation or delivery", 'interventionNames': ['Drug: Vaginal Progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intramuscular Progesterone', 'description': "250mg intramuscular progesterone to be administered weekly starting at 16 0/7 - 23 6/7 weeks, and continued weekly until 36 6/7 weeks' or delivery.", 'interventionNames': ['Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)']}], 'interventions': [{'name': 'Vaginal Progesterone', 'type': 'DRUG', 'otherNames': ['micronized progesterone'], 'armGroupLabels': ['Vaginal Progesterone']}, {'name': 'Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)', 'type': 'DRUG', 'otherNames': ['Makena'], 'armGroupLabels': ['Intramuscular Progesterone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rupsa C Boelig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University Hospital; Sidney Kimmel Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Results will be available, individual participant data may not be'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baystate Medical Center', 'class': 'OTHER'}, {'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'Vriginia Commonwealth University', 'class': 'UNKNOWN'}, {'name': 'Ohio State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-06', 'type': 'RELEASE'}, {'date': '2023-06-28', 'type': 'RESET'}, {'date': '2025-11-25', 'type': 'RELEASE'}, {'date': '2025-11-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Thomas Jefferson University'}}}}