Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT03077633
Status:
WITHDRAWN
Last Update Posted:
2018-03-21
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerclage for Twins With Short Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups: Cerclage + Progesterone vs. Progesterone alone'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Financial/business decision by Sponsor to not proceed with this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of very preterm birth (PTB)', 'timeFrame': 'Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.', 'description': 'Rate of very PTB (PTB less than 32 weeks)'}, {'measure': 'Rate of adverse perinatal outcome', 'timeFrame': 'Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.', 'description': 'The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cerclage', 'Cervical shortening', 'Twins', 'Progesterone'], 'conditions': ['Preterm Birth', 'Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2', 'Cervical Incompetence', 'Cervical Shortening']}, 'descriptionModule': {'briefSummary': 'A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (\\</= 15.0mm) between 16w0d to 25w6d.', 'detailedDescription': 'A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB\\<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)\n* Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.\n* Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.\n\nExclusion Criteria:\n\n* Maternal age less than 18 years\n* Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)\n* Rupture of membranes, either twin\n* One or both twins has no cardiac activity\n* One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios\n* Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus)\n* Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure\n* Symptomatic uterine contractions, 6 or more per hour\n* Ongoing bleeding from uterus\n* Patient declines to consider cerclage\n* Patient declines treatment with vaginal progesterone\n* Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.)\n* Cerclage is already in place\n* Cerclage placement is judged to be technically impossible\n* Patient has a history of poor follow-up or poor adherence to physician recommendations\n* Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable\n* Patient does not give consent to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT03077633', 'briefTitle': 'Cerclage for Twins With Short Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OBX0038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cervical Cerclage + Progesterone', 'description': 'Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)', 'interventionNames': ['Procedure: Cervical Cerclage placement', 'Drug: Vaginal Progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Progesterone', 'description': 'Daily administration of vaginal progesterone (200mg tab)', 'interventionNames': ['Drug: Vaginal Progesterone']}], 'interventions': [{'name': 'Cervical Cerclage placement', 'type': 'PROCEDURE', 'description': 'Cervical Cerclage placement', 'armGroupLabels': ['Cervical Cerclage + Progesterone']}, {'name': 'Vaginal Progesterone', 'type': 'DRUG', 'otherNames': ['Prometrium'], 'description': '200mg tab of vaginal progesterone administered daily from time of randomization until delivery.', 'armGroupLabels': ['Cervical Cerclage + Progesterone', 'Progesterone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrew Combs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatrix'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatrix', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}