Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-04 @ 7:01 AM
Study NCT ID:
NCT02484820
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of spontaneous delivery', 'timeFrame': '37 weeks of gestation', 'description': 'Comparison of the number of spontaneous delivery before 37 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.'}], 'secondaryOutcomes': [{'measure': 'Number of spontaneous delivery', 'timeFrame': '34 weeks of gestation', 'description': 'Comparison of the number of spontaneous delivery before 34 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.'}, {'measure': 'Number of spontaneous delivery', 'timeFrame': '28 weeks of gestation', 'description': 'Comparison of the number of spontaneous delivery before 28 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.'}, {'measure': 'Number of admission for preterm labor', 'timeFrame': 'from date of randomization until the date of the delivery', 'description': 'Comparison of the number of admission for preterm labor from date of randomization until the date of the delivery between the 2 groups.'}, {'measure': 'Number of fetal-neonatal death', 'timeFrame': 'at delivery', 'description': 'Number of fetal-neonatal death at delivery'}, {'measure': 'Number of birth death', 'timeFrame': 'From date of delivery until 6 weeks after the date of term', 'description': 'Number of birth death at delivery until 6 weeks after the date of term'}, {'measure': 'Number of patients with neonatal morbidity', 'timeFrame': 'From date of delivery until 6 weeks after the date of term', 'description': 'Number of patient with neonatal morbidity at delivery until 6 weeks after the date of term'}, {'measure': 'Number of patients with increase of vaginal discharge', 'timeFrame': 'from date of randomization until the date of the delivery', 'description': 'Comparison of the number of patients with increase of vaginal discharge from date of randomization until the date of the delivery between the 2 groups of the study.'}, {'measure': 'Number of patients with spontaneous pessary ejection', 'timeFrame': 'from date of randomization until the date of the delivery', 'description': 'Comparison of the number of patients with pessary ejection from date of randomization until the date of the delivery between the 2 groups of the study.'}, {'measure': 'Number of patients with discomfort', 'timeFrame': 'from date of randomization until the date of the delivery', 'description': 'Comparison of the number of patients with discomfort from date of randomization until the date of the delivery between the 2 groups of the study. The discomfort is measure by a standardized questionnaire.'}, {'measure': 'number of day between resolutive threatened preterm labor and delivery', 'timeFrame': 'At delivery', 'description': 'Comparison of number of day between the two groups of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm Birth', 'pessary', 'threatened preterm labor'], 'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.\n\nAfter 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.\n\nA pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.\n\nThe multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.\n\nTo evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimal age of 18 years\n* Informed consent\n* Confirmation of dating of pregnancy by first trimester echography.\n* Episode of threatened preterm labour\n* Singleton between 24 and 34 weeks of gestation\n* Cervical length ≤20mm in cervimetry\n* Pulmonary maturation completed\n* ≤6 contractions by hour after 24 hours of tocolysis.\n\nExclusion Criteria:\n\n* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)\n* Spontaneous rupture of membranes at the time of randomization\n* Cervical cerclage in situ\n* Uterus malformations\n* Antecedent of conisation\n* Active vaginal bleeding, placenta previa\n* Intra-amniotic infection\n* Hydramnios\n* Maternal chronic pathology (hypertension, diabetes)\n* Anomaly of breathing foetal rate'}, 'identificationModule': {'nctId': 'NCT02484820', 'acronym': 'PREMAPESSAIRE', 'briefTitle': 'Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial', 'orgStudyIdInfo': {'id': '1508059'}, 'secondaryIdInfos': [{'id': '2015-A00672-47', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pessary', 'description': 'Silicone pessary is associated with standard care Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)', 'interventionNames': ['Device: Silicone pessary']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care only, No silicone pessary will be placed in the vagina.'}], 'interventions': [{'name': 'Silicone pessary', 'type': 'DEVICE', 'description': 'Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)', 'armGroupLabels': ['Pessary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Céline CHAULEUR, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}