Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT07190157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship of DV Doppler Parameters to Perinatal Outcomes in IUGR vs Non-IUGR
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perinatal Mortality', 'timeFrame': 'From delivery up to 7 days postpartum', 'description': 'Death of the fetus or neonate, including stillbirth and neonatal death.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perinatal Outcome', 'Fetal Growth Restriction', 'Pregnancy'], 'conditions': ['Fetal Growth Restriction', 'Perinatal Outcome', 'Pregnancy, High Risk']}, 'referencesModule': {'references': [{'pmid': '31784981', 'type': 'BACKGROUND', 'citation': 'Fratelli N, Amighetti S, Bhide A, Fichera A, Khalil A, Papageorghiou AT, Prefumo F, Thilaganathan B. Ductus venosus Doppler waveform pattern in fetuses with early growth restriction. Acta Obstet Gynecol Scand. 2020 May;99(5):608-614. doi: 10.1111/aogs.13782. Epub 2019 Dec 22.'}, {'pmid': '21154784', 'type': 'BACKGROUND', 'citation': 'Cruz-Martinez R, Figueras F, Benavides-Serralde A, Crispi F, Hernandez-Andrade E, Gratacos E. Sequence of changes in myocardial performance index in relation to aortic isthmus and ductus venosus Doppler in fetuses with early-onset intrauterine growth restriction. Ultrasound Obstet Gynecol. 2011 Aug;38(2):179-84. doi: 10.1002/uog.8903. Epub 2011 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'This observational study investigates whether blood flow in the ductus venosus, a small fetal vein measured by Doppler ultrasound, is related to pregnancy outcomes. A total of pregnant women with and without intrauterine growth restriction (IUGR) will be examined between 24 and 37 weeks of gestation. Ductus venosus Doppler parameters will be recorded and compared with perinatal outcomes such as Apgar scores, neonatal intensive care unit admission, and perinatal mortality. The aim of this research is to improve the early identification of high-risk pregnancies and to support better monitoring and management strategies for fetal health.', 'detailedDescription': 'Detailed Description:\n\nIntrauterine growth restriction (IUGR) is a major cause of perinatal morbidity and mortality and has been associated with impaired fetal circulation. The ductus venosus (DV) plays a critical role in fetal hemodynamics by directing oxygenated blood to the heart and brain. Abnormal DV Doppler waveforms have been linked to adverse perinatal outcomes, particularly in growth-restricted fetuses.\n\nThis prospective observational case-control study will include approximately 160 singleton pregnancies between 24 and 37 weeks of gestation, of which 80 will be diagnosed with IUGR and 80 will be healthy controls. Doppler parameters of the DV, including pulsatility index, peak velocity, and a-wave characteristics, will be measured. These values will be correlated with perinatal outcomes such as Apgar scores, neonatal intensive care unit admission, and perinatal mortality.\n\nThe study is expected to provide further insight into the predictive value of DV Doppler in differentiating high-risk pregnancies and to contribute to improved prenatal surveillance and management strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group/Cohort 1: IUGR Group Title: IUGR Group Description: Pregnant women with singleton fetuses between 24-37 weeks of gestation, with abdominal circumference (AC) and/or estimated fetal weight (EFW) below the 10th percentile.\n\nGroup/Cohort 2: Control Group Title: Control Group Description: Pregnant women with singleton fetuses between 24-37 weeks of gestation, with AC and/or EFW between the 10th and 90th percentile (appropriate-for-gestational-age).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies between 24 and 37 weeks of gestation Singleton pregnancies with abdominal circumference (AC) and/or estimated fetal weight (EFW) below the 10th percentile for gestational age Singleton pregnancies with abdominal circumference (AC) and/or estimated fetal weight (EFW) between the 10th and 90th percentiles for gestational age\n\nExclusion Criteria:\n\nMultiple pregnancies Pregnancies with major fetal structural anomalies or chromosomal abnormalities Pregnant women with maternal systemic comorbidities (e.g., diabetes mellitus, chronic hypertension, renal disease, autoimmune disorders) Pregnancies in women under 18 years of age Presence of perinatal infection Pregnancies conceived by in vitro fertilization (IVF)\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07190157', 'acronym': 'DV-FGR', 'briefTitle': 'Relationship of DV Doppler Parameters to Perinatal Outcomes in IUGR vs Non-IUGR', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Izmir City Hospital'}, 'officialTitle': 'Evaluation of the Relationship Between Ductus Venosus Doppler Parameters and Perinatal Outcomes in Pregnancies With and Without Intrauterine Growth Restriction', 'orgStudyIdInfo': {'id': '2024/212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IUGR Group', 'description': 'Pregnant women with singleton fetuses between 24-37 weeks of gestation, with abdominal circumference (AC) and/or estimated fetal weight (EFW) below the 10th percentile.'}, {'label': 'Control Group', 'description': 'Pregnant women with singleton fetuses between 24-37 weeks of gestation, with AC and/or EFW between the 10th and 90th percentile (appropriate-for-gestational-age).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Izmir', 'state': 'BAYRAKLI', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hale Ankara Aktaş', 'role': 'CONTACT', 'email': 'haleankara@gmail.com', 'phone': '+90 (232) 955 05 00'}, {'name': 'İlayda Gercik Arzik', 'role': 'CONTACT', 'email': 'ilgercik@gmail.com', 'phone': '+90 (232) 955 05 00'}], 'facility': 'Izmir city hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir City Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Hale Ankara Aktaş, dr', 'role': 'CONTACT', 'email': 'haleankara@gmail.com', 'phone': '(0232) 955 05 00'}], 'overallOfficials': [{'name': 'Hakan Gölbasi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izmir City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'NO,'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}