Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT04110704
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerclage After Full Dilatation Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-10', 'size': 1506189, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-29T13:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation', 'timeFrame': 'Up to 42 weeks'}], 'secondaryOutcomes': [{'measure': 'CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.', 'timeFrame': 'Up to 48 weeks', 'description': 'We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.'}, {'measure': 'CRAFT-OBS: Number of participants with adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services)', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'CRAFT-OBS: Number of participants who deliver <34 weeks gestation', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Gestation at delivery', 'timeFrame': 'Up to 42 weeks', 'description': 'The proportion of participants who delivery at each gestation of completed weeks'}, {'measure': 'CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Any cervical length measurements taken antenatally', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Number of antenatal hospital appointments', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Number of hospital admissions', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Number of ultrasound indicated antenatal interventions', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies', 'timeFrame': 'Up to 48 weeks', 'description': 'COPOP core outcomes'}, {'measure': 'CRAFT-RCT: Number of participants with an adverse perinatal outcome', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'CRAFT-RCT: Gestation at delivery', 'timeFrame': 'Up to 42 weeks', 'description': 'Proportion of participants who deliver at each gestation of completed weeks'}, {'measure': 'CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)', 'timeFrame': 'Up to 30 weeks'}, {'measure': 'CRAFT-RCT: Time between intervention and delivery.', 'timeFrame': 'Up to 42 weeks'}, {'measure': 'CRAFT-RCT - Health costs at 28 days post-delivery.', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'CRAFT-IMG: Evidence of cervical injury', 'timeFrame': 'Up to 40 weeks', 'description': 'Size of any cervical lesion and its location seen on MRI or ultrasound scans'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth', 'Preterm Premature Rupture of Membrane', 'Preterm Spontaneous Labor With Preterm Delivery']}, 'referencesModule': {'availIpds': [{'id': 'IRAS 261294', 'url': 'http://preview-kcl.cloud.contensis.com/Preview/1/research/project?id=478a6e61-4446-4a12-945e-c41a3879371d', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth \\<34 weeks and \\<37 weeks.\n\nCRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation\n\nCRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'CRAFT-OBS\n\nInclusion Criteria:\n\n* Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.\n* Singleton pregnancy.\n* Willing and able to give informed consent (with or without interpreter).\n\nExclusion Criteria:\n\n* Under 16 years of age.\n* Inability to give informed consent.\n* Previous caesarean section carried out before labour.\n* Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study\n\nCRAFT-RCT:\n\nInclusion criteria:\n\n* Pregnant women up to 23+6 weeks gestation with a history of FDCS.\n* Short cervix (\\<=25mm) on transvaginal ultrasound scan.\n\nExclusion criteria:\n\n* Women with persistent fresh vaginal bleeding evident on speculum examination.\n* Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.\n* Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).\n* Known significant congenital or structural or chromosomal fetal abnormality.\n* Suspected or proven rupture of the fetal membranes at the time of recruitment.\n\nCRAFT-IMG\n\nInclusion criteria:\n\n* Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.\n\nExclusion criteria:\n\n* Contraindications to MRI, e.g. claustrophobia, BMI \\>40 kg/m2 (due to technical limitations of scanner) or a women with a non-MRI compatible metallic implant.'}, 'identificationModule': {'nctId': 'NCT04110704', 'acronym': 'CRAFT', 'briefTitle': 'Cerclage After Full Dilatation Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies', 'orgStudyIdInfo': {'id': '261294'}, 'secondaryIdInfos': [{'id': '42833', 'type': 'OTHER', 'domain': 'CPMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transvaginal cerclage', 'interventionNames': ['Procedure: Insertion of transvaginal cerclage']}, {'type': 'NO_INTERVENTION', 'label': 'Active monitoring'}], 'interventions': [{'name': 'Insertion of transvaginal cerclage', 'type': 'PROCEDURE', 'description': 'Transvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia.', 'armGroupLabels': ['Transvaginal cerclage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Agnieszka Glazewska-Hallin', 'role': 'CONTACT'}], 'facility': "Guy's and St Thomas' Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Agnieszka Glazewska-Hallin', 'role': 'CONTACT', 'email': 'agnieszka.glazewska-hallin@kcl.ac.uk', 'phone': '020 7188', 'phoneExt': '8151'}, {'name': 'Michael Waring', 'role': 'CONTACT', 'phone': 'michael.waring@kcl.ac.uk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}