Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT00201656
Status:
TERMINATED
Last Update Posted:
2014-12-19
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'This trial was terminated following a futility analysis confirming futility of continuing the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness', 'timeFrame': 'conception to birth'}, {'measure': 'Composite neonatal outcome - any one of the following (for twins, either infant): Fetal or neonatal death', 'timeFrame': 'Birth to 28days of life'}, {'measure': 'Respiratory distress syndrome', 'timeFrame': 'birth to 28days of life'}, {'measure': 'Documented sepsis within 72 hours of delivery', 'timeFrame': 'birth to 72 hours after delivery'}, {'measure': 'Grade 3 or 4 intraventricular hemorrhage', 'timeFrame': 'birth to 28days of life'}, {'measure': 'Stage 2 or 3 necrotizing enterocolitis', 'timeFrame': 'birth to 28days of life'}, {'measure': 'Neonatal intensive care unit (NICU) stay', 'timeFrame': 'birth to 28days of life'}, {'measure': 'Birth weight', 'timeFrame': 'at birth'}, {'measure': 'Estimated gestational age (EGA) at delivery', 'timeFrame': 'at delivery'}, {'measure': 'Postpartum endometritis', 'timeFrame': 'birth to 28days of life'}, {'measure': 'Maternal sepsis', 'timeFrame': 'birth to 28days following delivery'}, {'measure': 'Latency', 'timeFrame': 'labor to delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PPROM', 'Cerclage', 'Preterm Premature Rupture of the Membranes with Cerclage'], 'conditions': ['Fetal Membranes, Premature Rupture']}, 'referencesModule': {'references': [{'pmid': '1892180', 'type': 'BACKGROUND', 'citation': 'Treadwell MC, Bronsteen RA, Bottoms SF. Prognostic factors and complication rates for cervical cerclage: a review of 482 cases. Am J Obstet Gynecol. 1991 Sep;165(3):555-8. doi: 10.1016/0002-9378(91)90283-w.'}, {'type': 'BACKGROUND', 'citation': 'American College of Obstetricians and Gynecologists. Preterm Labor. Technical Bulletin no. 206,1995.'}, {'pmid': '11035323', 'type': 'BACKGROUND', 'citation': 'McElrath TF, Norwitz ER, Lieberman ES, Heffner LJ. Management of cervical cerclage and preterm premature rupture of the membranes: should the stitch be removed? Am J Obstet Gynecol. 2000 Oct;183(4):840-6. doi: 10.1067/mob.2000.108870.'}, {'pmid': '11035324', 'type': 'BACKGROUND', 'citation': 'Jenkins TM, Berghella V, Shlossman PA, McIntyre CJ, Maas BD, Pollock MA, Wapner RJ. Timing of cerclage removal after preterm premature rupture of membranes: maternal and neonatal outcomes. Am J Obstet Gynecol. 2000 Oct;183(4):847-52. doi: 10.1067/mob.2000.109039.'}, {'pmid': '7936520', 'type': 'BACKGROUND', 'citation': 'Ludmir J, Bader T, Chen L, Lindenbaum C, Wong G. Poor perinatal outcome associated with retained cerclage in patients with premature rupture of membranes. Obstet Gynecol. 1994 Nov;84(5):823-6.'}, {'pmid': '11731894', 'type': 'BACKGROUND', 'citation': 'Naylor CS, Gregory K, Hobel C. Premature rupture of the membranes: an evidence-based approach to clinical care. Am J Perinatol. 2001 Nov;18(7):397-413. doi: 10.1055/s-2001-18699.'}, {'pmid': '24726507', 'type': 'DERIVED', 'citation': 'Galyean A, Garite TJ, Maurel K, Abril D, Adair CD, Browne P, Combs CA, How H, Iriye BK, Kominiarek M, Lu G, Luthy D, Miller H, Nageotte M, Ozcan T, Porto M, Ramirez M, Sawai S, Sorokin Y; Obstetrix Perinatal Collaborative Research Network. Removal versus retention of cerclage in preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol. 2014 Oct;211(4):399.e1-7. doi: 10.1016/j.ajog.2014.04.009. Epub 2014 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether retention of cervical cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.', 'detailedDescription': 'The placement of cervical cerclage is standard of care for women who experience incompetent cervix. Treadwell et al, published the largest retrospective review of 482 patients receiving cerclage (364 elective and 118 emergent). They found premature rupture of membranes (PROM) in 38% of the subjects with 9% delivering \\<27 weeks. Preterm birth is the cause of at least 75% of neonatal deaths that are not due to congenital malformations. The question of whether to remove cerclage after preterm premature rupture of membranes (PPROM) is one of the unresolved controversies in obstetrics because the few available studies are retrospective, all have small numbers of patients, and the studies have given conflicting results regarding the safety of retaining a cerclage after preterm premature rupture of the membranes. It is unclear from the retrospective studies whether latency (the interval from membrane rupture to the onset of labor) is prolonged with retention of the suture. Furthermore, some, but not all studies suggest an increase in major infectious maternal morbidity and possibly neonatal morbidity. For this reason, clinicians vary greatly in deciding on whether to remove a cerclage in a patient with PPROM and either practice is currently an acceptable standard. This is a fairly rare complication, the combination of PPROM in a patient with cerclage in place only occurs in about 1-3/1000 pregnant women. Thus it has been impossible to study this problem prospectively in any single institution. The establishment of the Obstetrix Collaborative Research Group affords the unique opportunity to study this rare complication. Obstetrix manages 19 practices of Perinatologists around the U.S. and Mexico and is comprised of nearly 100 such subspecialists. This problem is most often referred to a Perinatologist when it occurs, so it is not unusual for these practices to see 5 - 10 such patients per year. Obstetrix fully funds the infrastructure of this research group and inclusion in this study will not alter the cost of patient care in either group as there is virtually no cost in removing the cerclage and all these patients are kept in hospital until delivery when membranes rupture as standard of care.\n\nThis is a multicenter trial. The purpose is to determine whether retention of cerclage after preterm premature rupture of the membranes improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A previously placed prophylactic cerclage defined as any cerclage done \\< 23 6/7 weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation \\< 3 cm\n2. Spontaneous rupture of membranes 22-32 weeks\n3. Singleton or twin gestation\n4. Shirodkar or McDonald cerclage in place \\> 1 week\n\nExclusion Criteria:\n\n1. Active labor (\\> 8 uterine contractions \\[UCs\\] per hour)\n2. Chorioamnionitis as defined by temperature \\> 38 plus fetal tachycardia or uterine tenderness\n3. Placenta previa or undiagnosed vaginal bleeding\n4. Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP)\n5. Mature pulmonary studies\n6. Positive gram stain, culture, white blood cells (WBC) \\> 30, or glucose \\< 14 on amniocentesis\n7. Major fetal anomaly\n8. Presentation \\> 48 hours after rupture of membranes\n9. abdominal cerclage\n10. Cerclage done for symptomatic cervical dilation (cervix dilated \\> 3 cm)\n11. Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)'}, 'identificationModule': {'nctId': 'NCT00201656', 'acronym': 'PROMCerclage', 'briefTitle': 'Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OBX0002'}, 'secondaryIdInfos': [{'id': 'OBX0002', 'type': 'OTHER', 'domain': 'Obstetrix CREQ Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Retention of Cerclage', 'description': 'Group one = Subject whose Cerclage is retained after randomization.', 'interventionNames': ['Procedure: Retention of Cerclage', 'Procedure: Removal vs. Retention of Cervical Cerclage']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 - Removal of Cerclage', 'description': 'Group 2 = Subjects who will have cerclage removed after randomization', 'interventionNames': ['Procedure: Removal of Cerclage', 'Procedure: Removal vs. Retention of Cervical Cerclage']}], 'interventions': [{'name': 'Retention of Cerclage', 'type': 'PROCEDURE', 'description': 'Retain Cerclage until clinical removal is indicated by protocol', 'armGroupLabels': ['1 Retention of Cerclage']}, {'name': 'Removal of Cerclage', 'type': 'PROCEDURE', 'description': 'Immediate removal of Cerclage following randomization', 'armGroupLabels': ['2 - Removal of Cerclage']}, {'name': 'Removal vs. Retention of Cervical Cerclage', 'type': 'PROCEDURE', 'otherNames': ['McDonald or Shirodkar Cerclage'], 'description': 'Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress', 'armGroupLabels': ['1 Retention of Cerclage', '2 - Removal of Cerclage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Good Samaritan Hospital', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Memorial Medical Center', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90801-1428', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California-Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80110', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Presbyterian/St Luke's Hospital", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New-Haven Medical Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lousiana State University Health Science', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Hutzel Women's Hospital", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital, Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sunrise Medical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Sacred Heart Medical Center', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Medical Center', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Hospital', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '98122-4307', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Kimberly Maurel, RN, MSN, CNS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Obstetrix Medical Group, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrix Medical Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}