Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-30 @ 11:39 AM
Study NCT ID:
NCT05034861
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2021-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015150', 'term': 'Echocardiography, Doppler'}], 'ancestors': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Condition at birth', 'timeFrame': '5 minutes after delivery', 'description': 'Incidence of Apgar score at 5 min \\<7 or arterial pH of \\<7.0 or venous \\<7.1 or resuscitation (compressions, medications, intubation)'}, {'measure': 'Neonatal Intensive Care Unit admission', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'Incidence any admission to the Neonatal Intensive Care Unit'}, {'measure': 'Brain injury', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'Incidence of Intraventricular haemorrhage (IVH) grade II or above-defined as bleeding into the ventricles; or hypoxic-ischaemic encephalopathy or periventricular leukomalacia or seizures recorded by EEG'}, {'measure': 'Ventilation', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate'}, {'measure': 'Respiratory distress syndrome', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'defined as need of surfactant and ventilation as a result of prematurity'}, {'measure': 'Cardiovascular support/treatment', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment'}, {'measure': 'Neonatal sepsis', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis\n\n\\- Necrotising enterocolitis (NEC)'}, {'measure': 'Retinopathy', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier', 'description': 'incidence of retinopathy requiring laser or anti-VEGF administration'}, {'measure': 'Fetal/neonatal death', 'timeFrame': 'anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier', 'description': 'Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier'}], 'secondaryOutcomes': [{'measure': 'Maternal anxiety levels', 'timeFrame': 'at the recruitment visit and every 2 weeks until delivery', 'description': 'measured by a screening Generalized Anxiety Disorder 7- question scale (GAD-7 scale). There are four possible answers to all the questions, corresponding to scores 0,1,2,3, respectively, therefore the total score ranges between 0 (not anxious) - 21 (severely anxious).'}, {'measure': 'Compliance', 'timeFrame': 'after the recruitment visit until delivery', 'description': 'adherence to the plan of care - % of the patients attending scheduled visits'}, {'measure': 'Number of hospital visits', 'timeFrame': 'after the recruitment visit until delivery', 'description': 'total number of meetings with the healthcare provider'}, {'measure': 'Mode of delivery', 'timeFrame': 'through study completion, an average of 5 weeks after the recruitment visit', 'description': 'rate of vaginal/caesarean; spontaneous/planned/emergency'}, {'measure': 'Onset of labour', 'timeFrame': 'through study completion, an average of 5 weeks after the recruitment visit', 'description': 'rate of spontaneous/induced/caesarean before uterine contractions'}, {'measure': 'Gestational hypertension', 'timeFrame': "between 20 weeks' gestation - up to 6 weeks after birth", 'description': "incidence of new onset hypertension (blood pressure ≥140/90 mmHg) after 20 weeks' of gestation in the absence of preeclampsia as defined by International Society for Study of Hypertension in Pregnancy (ISSHP)"}, {'measure': 'Preeclampsia', 'timeFrame': "between 20 weeks' gestation - up to 6 weeks after birth", 'description': 'incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fetal growth restriction', 'fetal growth retardation', 'pregnancy', 'cardiotocography', 'ultrasound', 'Doppler', 'intrauterine growth restriction', 'maternal-fetal medicine', 'obstetrics'], 'conditions': ['Fetal Growth Restriction']}, 'referencesModule': {'references': [{'pmid': '32738107', 'type': 'RESULT', 'citation': 'Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.'}, {'pmid': '30950117', 'type': 'RESULT', 'citation': 'Nohuz E, Riviere O, Coste K, Vendittelli F. Prenatal identification of small-for-gestational age and risk of neonatal morbidity and stillbirth. Ultrasound Obstet Gynecol. 2020 May;55(5):621-628. doi: 10.1002/uog.20282. Epub 2020 Apr 6.'}, {'pmid': '30883981', 'type': 'RESULT', 'citation': "Ciobanu A, Khan N, Syngelaki A, Akolekar R, Nicolaides KH. Routine ultrasound at 32 vs 36 weeks' gestation: prediction of small-for-gestational-age neonates. Ultrasound Obstet Gynecol. 2019 Jun;53(6):761-768. doi: 10.1002/uog.20258. Epub 2019 Apr 30."}, {'pmid': '24839087', 'type': 'RESULT', 'citation': 'Figueras F, Gratacos E. Stage-based approach to the management of fetal growth restriction. Prenat Diagn. 2014 Jul;34(7):655-9. doi: 10.1002/pd.4412. Epub 2014 Jun 9.'}, {'pmid': '26909664', 'type': 'RESULT', 'citation': 'Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.'}, {'pmid': '31520557', 'type': 'RESULT', 'citation': 'Molina LCG, Odibo L, Zientara S, Obican SG, Rodriguez A, Stout M, Odibo AO. Validation of Delphi procedure consensus criteria for defining fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Jul;56(1):61-66. doi: 10.1002/uog.20854. Epub 2020 Jun 7.'}, {'pmid': '29606482', 'type': 'RESULT', 'citation': 'Baschat AA. Planning management and delivery of the growth-restricted fetus. Best Pract Res Clin Obstet Gynaecol. 2018 May;49:53-65. doi: 10.1016/j.bpobgyn.2018.02.009. Epub 2018 Mar 1.'}, {'pmid': '30878322', 'type': 'RESULT', 'citation': "Akolekar R, Ciobanu A, Zingler E, Syngelaki A, Nicolaides KH. Routine assessment of cerebroplacental ratio at 35-37 weeks' gestation in the prediction of adverse perinatal outcome. Am J Obstet Gynecol. 2019 Jul;221(1):65.e1-65.e18. doi: 10.1016/j.ajog.2019.03.002. Epub 2019 Mar 13."}, {'pmid': '31990493', 'type': 'RESULT', 'citation': 'Antenatal and postnatal mental health: clinical management and service guidance. London: National Institute for Health and Care Excellence (NICE); 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK553127/'}, {'pmid': '33166504', 'type': 'RESULT', 'citation': 'Lai J, Syngelaki A, Nicolaides KH, von Dadelszen P, Magee LA. Impact of new definitions of preeclampsia at term on identification of adverse maternal and perinatal outcomes. Am J Obstet Gynecol. 2021 May;224(5):518.e1-518.e11. doi: 10.1016/j.ajog.2020.11.004. Epub 2020 Nov 6.'}]}, 'descriptionModule': {'briefSummary': "Fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. Growth restricted fetuses do not reach their potential due to multiple factors. Although early (\\<32 weeks' gestation) FGR is associated with the highest risk of adverse outcomes, late FGR (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. Despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR (COSMOS) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset FGR observation.\n\nAll women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial. Patients will be randomly divided into two groups: CTG - a group that will receive electronic device for cCTG home assessment, and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria. Further management will depend on the arm of the study. Pregnancy and neonatal outcomes will be collected and analyzed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant individuals', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women aged 18 years or older,\n* singleton pregnancy,\n* ≥32+0 and ≤36+6 weeks' of gestation,\n* fluent in Polish or English,\n* diagnosed with late-onset FGR based of the Delphi criteria,\n* with positive EDF in UA,\n* with macroscopically normal fetus on ultrasound assessment.\n\nExclusion Criteria:\n\n* multiple pregnancy,\n* fetal malformations,\n* abnormal genetic testing results (if available),\n* uncertain pregnancy dating,\n* indication for immediate delivery within 48 hours after enrollment,\n* preterm prelabour rupture of membranes."}, 'identificationModule': {'nctId': 'NCT05034861', 'acronym': 'COSMOS', 'briefTitle': 'COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mother and Child, Warsaw, Poland'}, 'officialTitle': 'COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'InstituteMCPoland'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cCTG', 'description': 'cCTG group, that will undergo a following process: EFW and Doppler assessment biweekly, and instead of additional weekly Doppler-only assessment, the patients will be provided with an electronic cCTG device at no cost (Carebits). Women will be asked to apply Carebits device at least twice weekly for at least 30 minutes (e.g. Mondays-Thursdays) with minimum 72 hours interval in case of 2 sessions per week. The trace will be examined by an independent centre, available 24 hours daily. The person examining the trace is trained or already specialized in Obs\\&Gynae. In case of situation requiring medical intervention, the patient will be immediately contacted by phone and advised to self-refer to the nearest Antenatal Unit. In case of normal trace, a full report will follow within 30 minutes after last reading of the trace.', 'interventionNames': ['Device: cCTG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doppler', 'description': 'Doppler group, that will undergo a standard process of antenatal care in case of FGR. The EFW and CTG STV will be assessed biweekly. In case of positive end-diastolic flow in UA, Doppler assessment (MCA PI, UA PI, DV PI, Ut PI) will be provided on a weekly basis. In case of deterioration to AEDF/REDF, further management will depend on clinical situation and the patient will be excluded from the study group (applies to both arms).', 'interventionNames': ['Diagnostic Test: Doppler']}], 'interventions': [{'name': 'cCTG', 'type': 'DEVICE', 'otherNames': ['Carebits device', 'www.carebits.pl'], 'description': 'Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.', 'armGroupLabels': ['cCTG']}, {'name': 'Doppler', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Doppler assessment'], 'description': 'Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.', 'armGroupLabels': ['Doppler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-211', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Fijałkowska, Professor', 'role': 'CONTACT', 'email': 'anna.fijalkowska@imid.med.pl', 'phone': '+48223277383'}, {'name': 'Urszula Nowacka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karolina Krajewska, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Mother and Child', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Urszula Nowacka, MD', 'role': 'CONTACT', 'email': 'ulasarzynska@gmail.com; urszula.nowacka@imid.med.pl', 'phone': '+48223277044'}, {'name': 'Tadeusz Issat, Professor', 'role': 'CONTACT', 'email': 'tadeusz.issat@imid.med.pl', 'phone': '+48223277044'}], 'overallOfficials': [{'name': 'Urszula Nowacka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Mother and Child, Warsaw, Poland'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'The deidentified participant data will become available upon publishing the protocol and results of the study. Study protocol will be available immediately following publication.', 'ipdSharing': 'YES', 'description': 'Data will be available on reasonable request', 'accessCriteria': 'The data will be provided on request for anyone after methodologically sound proposal (contact details: urszula.nowacka@imid.med.pl).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mother and Child, Warsaw, Poland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bielanski Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Urszula Nowacka', 'investigatorAffiliation': 'Institute of Mother and Child, Warsaw, Poland'}}}}