Ductus Venosus Doppler in IUGR Pregnancies

NCT ID: NCT07193381

Last Updated: 2025-09-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intrauterine Growth Restriction (IUGR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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İlayda Gercik Arzık, MD

OTHER_GOV

Sponsor Role lead

Responsible Party

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İlayda Gercik Arzık, MD

MD, Perinatology Specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hakan Golbasi, Assistant Professor

Role: STUDY_DIRECTOR

Izmir City Hospital

Locations

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Izmir City Hospital

Izmir, Bayrakli, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ILAYDA GERCIK ARZIK, MD

Role: CONTACT

+905556124197

Hale Ankara Aktas, MD

Role: CONTACT

+905415470595

Facility Contacts

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Ilayda Gercik Arzik, MD

Role: primary

+905556124197

Hale Ankara Aktas, MD

Role: backup

+905415470595

Other Identifiers

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2025/337

Identifier Type: -

Identifier Source: org_study_id

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