Izmir City Hospital
Izmir, Bayrakli, 35540, Turkey (Türkiye)
NCT Number: NCT07193381
This prospective observational cohort study aims to evaluate the relationship between ductus venosus Doppler parameters and perinatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR). Pregnant women diagnosed with IUGR will undergo longitudinal Doppler assessments of the ductus venosus during the third trimester. The Doppler indices will be correlated with perinatal outcomes, including Apgar scores, neonatal intensive care unit (NICU) admission, and perinatal mortality. The study seeks to determine whether serial ductus venosus Doppler measurements can serve as predictive markers of adverse neonatal outcomes in IUGR pregnancies.
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Notify Me18 year–45 year
Female
Observational
Izmir, Bayrakli, 35540, Turkey (Türkiye)
Intrauterine growth restriction (IUGR) is a major obstetric complication associated with increased risks of perinatal morbidity and mortality. Accurate assessment of fetal well-being and timely prediction of adverse outcomes are critical in the management of these pregnancies. The ductus venosus, a key component of the fetal circulation, reflects central venous pressure and cardiac function. Alterations in ductus venosus Doppler waveforms have been suggested as early markers of fetal compromise.
This prospective observational cohort study is designed to longitudinally evaluate ductus venosus Doppler parameters in pregnancies diagnosed with IUGR and to explore their association with perinatal outcomes. Pregnant women meeting the inclusion criteria will undergo serial Doppler examinations of the ductus venosus during the third trimester, performed at defined intervals until delivery.
Perinatal outcomes to be assessed include Apgar scores, neonatal intensive care unit (NICU) admission, duration of hospitalization, and perinatal mortality. By correlating longitudinal ductus venosus Doppler changes with clinical outcomes, the study aims to determine whether these parameters may serve as reliable predictors of neonatal risk in IUGR pregnancies. Ultimately, this research may provide additional evidence to support the use of ductus venosus Doppler in clinical decision-making and in the timing of delivery for growth-restricted fetuses.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Female participants aged 18-45 years
Singleton pregnancy
Intrauterine growth restriction (IUGR) with estimated fetal weight <10th percentile for gestational age
Gestational age ≥24 weeks at enrollment
Ability to comply with scheduled follow-up visits and Doppler examinations
Signed informed consent obtained
Exclusion criteria
Multiple gestations (twins or higher-order pregnancies)
Major fetal congenital anomalies
Known chromosomal abnormalities
Maternal chronic systemic diseases likely to affect fetal growth (e.g., uncontrolled diabetes mellitus, severe renal disease, severe hypertension)
Maternal infections known to impact fetal growth (e.g., TORCH infections)
Time frame: From delivery until neonatal discharge (up to 28 days postpartum)
A composite outcome including perinatal mortality, Apgar score <7 at 5 minutes, and NICU admission. The association between ductus venosus Doppler indices and this composite outcome will be analyzed.
Time frame: From study enrollment through delivery (up to 14 weeks), assessed weekly
Rate of change per week calculated from serial weekly Doppler exams.
İlayda Gercik Arzık, MD
Other Gov
Longitudinal Assessment of Ductus Venosus Doppler Parameters and Their Association With Perinatal Outcomes in Pregnancies With Intrauterine Growth Restriction
Acronym: IUGR-DV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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