Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-29 @ 12:54 PM
Study NCT ID:
NCT00432250
Status:
COMPLETED
Last Update Posted:
2007-02-07
First Post:
2007-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], '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': 'SINGLE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2007-02-06', 'studyFirstSubmitDate': '2007-02-06', 'studyFirstSubmitQcDate': '2007-02-06', 'lastUpdatePostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay'}, {'measure': 'Gestational age at delivery'}], 'secondaryOutcomes': [{'measure': 'Rate of hospital stay below 3 days'}, {'measure': 'Interval admission-to-delivery < 7 days'}, {'measure': 'Rate of preterm delivery before 37 weeks'}, {'measure': 'Rate of preterm delivery before 34 weeks'}]}, 'conditionsModule': {'keywords': ['Preterm labor', 'Cervical ultrasonography', 'Hospital stay'], 'conditions': ['Labor, Premature', 'Cervical Length']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.', 'detailedDescription': 'Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups:\n\nCONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol.\n\nSTUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted because of preterm labor\n* Not delivered after 24-48 h of admission\n* Single pregnancy\n* Intact membranes\n* Gestational age between 24.0 and less tahn 36.0 weeks\n* Bishop score \\< 6\n\nExclusion Criteria:\n\n* Fetal death or malformation\n* Signs of chorioamnionitis\n* Non-reassuring fetal test'}, 'identificationModule': {'nctId': 'NCT00432250', 'briefTitle': 'The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'orgStudyIdInfo': {'id': 'CLHSPTL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cervical length ultrasound', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Sabino de Arana 1', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic of Barcelona'}], 'overallOfficials': [{'name': 'Montse Palacio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}, {'name': 'Vicenç Cararach', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}}}}