Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-28 @ 6:49 PM
Study NCT ID:
NCT01380158
Status:
WITHDRAWN
Last Update Posted:
2021-02-17
First Post:
2011-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Preterm Birth With a Pessary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D002581', 'term': 'Uterine Cervical Incompetence'}], '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'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D000026', 'term': 'Abortion, Habitual'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delivery prior to 37 weeks of gestation', 'timeFrame': 'within the first 30 days after delivery of the neonate', 'description': 'Gestational age at birth will be recorded'}], 'secondaryOutcomes': [{'measure': 'Rate of birth less than seven days from randomization', 'timeFrame': 'within the first 30 days after delivery of the neonate', 'description': 'Gestational age at birth will be recorded'}, {'measure': 'Previable birth (<24 weeks)', 'timeFrame': 'within the first 30 days after delivery of the neonate', 'description': 'Gestational age at birth will be recorded'}, {'measure': 'Perinatal death', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'defined as either a stillbirth or postnatal death prior to hospital discharge'}, {'measure': 'Low birth weight', 'timeFrame': 'within the first 30 days after delivery of the neonate', 'description': 'Birthweight at delivery will be recorded'}, {'measure': 'Major adverse neonatal outcomes', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis'}, {'measure': 'Need for neonatal special care', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'ventilation, phototherapy, treatment for sepsis, blood transfusion'}, {'measure': 'Incidence of complications due to pessary', 'timeFrame': 'Every 4 weeks while pregnant with pessary in situ', 'description': 'Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pessary', 'preterm birth', 'short cervix', 'cervical incompetence'], 'conditions': ['Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '8569824', 'type': 'BACKGROUND', 'citation': 'Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.'}, {'pmid': '19788970', 'type': 'BACKGROUND', 'citation': 'Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.'}, {'pmid': '12802023', 'type': 'BACKGROUND', 'citation': "Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140."}, {'pmid': '5646408', 'type': 'BACKGROUND', 'citation': 'Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. doi: 10.1097/00006250-196805000-00024. No abstract available.'}, {'pmid': '5944837', 'type': 'BACKGROUND', 'citation': 'Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. doi: 10.1097/00003081-196608000-00011. No abstract available.'}, {'pmid': '12747228', 'type': 'BACKGROUND', 'citation': 'Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017.'}, {'pmid': '14669390', 'type': 'BACKGROUND', 'citation': 'Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachow J. [Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery]. Ginekol Pol. 2003 Oct;74(10):1029-36. Polish.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).\n* Women ages 18 to 45 years of age\n\nExclusion Criteria:\n\n* Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.\n* Presence of prophylactic cervical cerclage\n* Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)\n* Painful regular uterine contractions, or ruptured membranes\n* Visual cervical dilation of 2cm or greater and visible membranes.\n* Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.'}, 'identificationModule': {'nctId': 'NCT01380158', 'acronym': 'PrePPy', 'briefTitle': 'Preventing Preterm Birth With a Pessary', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Preventing Preterm Birth With a Pessary', 'orgStudyIdInfo': {'id': '2010-225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pessary use during pregnancy', 'description': 'Device: Cup pessary', 'interventionNames': ['Device: Cup pessary (Bioteque America, Inc)']}, {'type': 'NO_INTERVENTION', 'label': 'Expectant management', 'description': 'Expectant Management + weekly intramuscular progesterone injections'}], 'interventions': [{'name': 'Cup pessary (Bioteque America, Inc)', 'type': 'DEVICE', 'description': 'Placement of cup pessary in the vagina after randomization', 'armGroupLabels': ['Pessary use during pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Franklin Square Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Rita W Driggers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}