Relationship of DV Doppler Parameters to Perinatal Outcomes in IUGR vs Non-IUGR

NCT ID: NCT07190157

Last Updated: 2025-10-02

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

NOT_YET_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-11-30

Brief Summary

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This observational study investigates whether blood flow in the ductus venosus, a small fetal vein measured by Doppler ultrasound, is related to pregnancy outcomes. A total of pregnant women with and without intrauterine growth restriction (IUGR) will be examined between 24 and 37 weeks of gestation. Ductus venosus Doppler parameters will be recorded and compared with perinatal outcomes such as Apgar scores, neonatal intensive care unit admission, and perinatal mortality. The aim of this research is to improve the early identification of high-risk pregnancies and to support better monitoring and management strategies for fetal health.

Detailed Description

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Detailed Description:

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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Fetal Growth Restriction Perinatal Outcome Pregnancy, High Risk

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Singleton pregnancies between 24 and 37 weeks of gestation Singleton pregnancies with abdominal circumference (AC) and/or estimated fetal weight (EFW) below the 10th percentile for gestational age Singleton pregnancies with abdominal circumference (AC) and/or estimated fetal weight (EFW) between the 10th and 90th percentiles for gestational age

Exclusion Criteria

Multiple pregnancies Pregnancies with major fetal structural anomalies or chromosomal abnormalities Pregnant women with maternal systemic comorbidities (e.g., diabetes mellitus, chronic hypertension, renal disease, autoimmune disorders) Pregnancies in women under 18 years of age Presence of perinatal infection Pregnancies conceived by in vitro fertilization (IVF)

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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Izmir City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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)

Site Status

Izmir City Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hale Ankara Aktaş, dr

Role: CONTACT

(0232) 955 05 00

Facility Contacts

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Hale Ankara Aktaş

Role: primary

+90 (232) 955 05 00

İlayda Gercik Arzik

Role: backup

+90 (232) 955 05 00

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.

Reference Type BACKGROUND
PMID: 31784981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21154784 (View on PubMed)

Other Identifiers

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2024/212

Identifier Type: -

Identifier Source: org_study_id

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