Relationship of DV Doppler Parameters to Perinatal Outcomes in IUGR vs Non-IUGR
NCT ID: NCT07190157
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
160 participants
OBSERVATIONAL
2025-10-01
2025-11-30
Brief Summary
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Detailed Description
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Intrauterine 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.
This 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.
The 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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IUGR Group
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.
No interventions assigned to this group
Control Group
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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
\-
18 Years
45 Years
FEMALE
Yes
Sponsors
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Izmir City Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Hakan Gölbasi
Role: STUDY_DIRECTOR
Izmir City Hospital
Locations
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Izmir city hospital
Izmir, BAYRAKLI, Turkey (Türkiye)
Izmir City Hospital
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2024/212
Identifier Type: -
Identifier Source: org_study_id
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