Ductus Venosus Doppler in IUGR Pregnancies

N/ACompletedNCT07193381

İlayda Gercik Arzık, MD81 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intrauterine Growth Restriction (IUGR)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

Izmir City Hospital

Izmir, Bayrakli, Turkey (Türkiye)

Outcomes

Primary Outcomes

Composite adverse perinatal outcome (perinatal mortality, Apgar score <7 at 5 minutes, NICU admission)

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 delivery until neonatal discharge (up to 28 days postpartum)

Secondary Outcomes

Longitudinal change (slope) of ductus venosus PI during third trimester

Rate of change per week calculated from serial weekly Doppler exams.

Time frame: From study enrollment through delivery (up to 14 weeks), assessed weekly

Data from ClinicalTrials.gov

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