Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-18 @ 9:29 PM
Study NCT ID:
NCT02576418
Status:
UNKNOWN
Last Update Posted:
2017-09-11
First Post:
2015-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing', 'timeFrame': '7 or 14 days from testing', 'description': 'SN, SP, PPV and NPV superiority of PartoSure TTD test compared to CL measurement via transvaginal ultrasound (15 mm cutoff) for the presentation-to-spontaneous-delivery time intervals of ≤ 7 days or 14 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Partosure TTD test', 'CL', 'ART', 'SN', 'SP', 'PPV', 'NPV'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'To calculate sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) of PartoSure TTD test in predicting delivery within 7 or 14 days from testing and to compare it with cervical length (CL) measurement by transvaginal ultrasound (15 mm cut-off)', 'detailedDescription': '* This trial is a prospective observational study.\n* Pregnancies after ART between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor, clinically intact membranes, cervical dilatation of ≤ 2 cm will be invited to participate to the study. Signed consent form is required to be able to participate to the study.\n* PartoSure and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.\n* Trial Population:Pregnancies after ART between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor are hospitalized at My Duc hospital from October 2015 to April 2016. The sample size for this trial of 100 subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible for enrollment into this trial, each female subject must fulfill all of the following criteria at the start of enrollment:\n\n* Pregnancies after assisted reproductive technology include singleton and twins\n* Between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor including uterine contractions, intermittent lower abdominal pain and pelvic pressure.\n* Clinically intact membranes.\n* Cervical dilatation of ≤ 2 cm\n* Agree to participate in the study, and to disclose any medical events to the investigator\n* Have given written informed consent\n\nExclusion Criteria:\n\nTo be eligible for enrollment in this study each subject must not meet any of the following criteria:\n\n* Vaginal bleeding\n* Overt rupture of the fetal membranes as indicated by visualized leakage of fluid from the cervix\n* Placenta previa\n* Cervical cerclage in place\n* Received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or CL measurement.\n* Digital exam prior to specimen collection.\n* A symptom not associated with idiopathic threatened preterm delivery (e.g trauma)\n* Enrollment in a tocolytic study.'}, 'identificationModule': {'nctId': 'NCT02576418', 'briefTitle': 'PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam National University'}, 'officialTitle': 'Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)', 'orgStudyIdInfo': {'id': 'NCKH/CGRH_08_2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partosure TTD Test', 'description': 'PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.', 'interventionNames': ['Other: Partosure TTD test']}], 'interventions': [{'name': 'Partosure TTD test', 'type': 'OTHER', 'description': 'PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.', 'armGroupLabels': ['Partosure TTD Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'state': 'Ward 13. Tan Binh District', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Vinh Q Dang, MD', 'role': 'CONTACT', 'email': 'bsvinh.dq@myduchospital.vn', 'phone': '+84 908225481'}, {'name': 'Anh H Dang, MSc', 'role': 'CONTACT', 'email': 'anh.dh@myduchospital.vn', 'phone': '+ 84 908302412'}], 'facility': 'My Duc Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Tuong M Ho, Doctor', 'role': 'CONTACT', 'email': 'homanhtuong@yahoo.com', 'phone': '+ 84 903633377'}, {'name': 'Anh H Dang, MSc.', 'role': 'CONTACT', 'email': 'anh.dh@myduchospital.vn', 'phone': '+84 908 302412'}], 'overallOfficials': [{'name': 'Tuong M Ho, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Center for Genetics and Reproductive Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vietnam National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Manh Tuong Ho', 'investigatorAffiliation': 'Vietnam National University'}}}}