Ductus Venosus Doppler in IUGR Pregnancies

NCT07193381 | Completed

• 1 other identifier: 2025/337
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrauterine Growth Restriction (IUGR)

Keywords

Ductus Venosus; Doppler Ultrasound; Neonatal Intensive Care Unit (NICU)

Outcome Measures

Primary Outcomes (1)

• 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.

  From delivery until neonatal discharge (up to 28 days postpartum)

Secondary Outcomes (1)

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

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

Study Arms (1)

IUGR Pregnancies

Pregnant women diagnosed with intrauterine growth restriction will be followed longitudinally with serial ductus venosus Doppler assessments during the third trimester. Perinatal outcomes will be recorded until delivery and the early neonatal period.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18-45 years with singleton pregnancies diagnosed with intrauterine growth restriction (IUGR) will be recruited from the Department of Perinatology at Izmir City Hospital. Eligible participants will be followed with serial Doppler ultrasound examinations of the ductus venosus during the third trimester and monitored until delivery and the early neonatal period.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• İlayda Gercik Arzık, MD: lead

Study Sites (1)

Izmir City Hospital

Izmir, Bayrakli, 35540, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hakan Golbasi, Assistant Professor

  Izmir City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Perinatology Specialist

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 25, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)