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Not yet recruitingNCT07190157DV-FGRUpdated Oct 2, 2025

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

An observational study in Fetal Growth Restriction, Perinatal Outcome and Pregnancy, High Risk, sponsored by Izmir City Hospital. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Izmir City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 45 Years
Sex
Female
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Fetal Growth Restriction
  • Perinatal Outcome
  • Pregnancy, High Risk

Keywords

  • Perinatal Outcome
  • Fetal Growth Restriction
  • Pregnancy
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In context

Fetal Growth Retardation

264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.

This study's planned enrollment of 160 is close to the median of 161 across 142 observational studies indexed under Fetal Growth Retardation.

Browse Fetal Growth Retardation studies →

Lead sponsor

Izmir City Hospital is the lead sponsor of 23 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Group/Cohort 1: IUGR Group Title: IUGR Group Description: 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.

Group/Cohort 2: Control Group Title: Control Group Description: 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).

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

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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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

  • 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).

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What researchers measure

Primary outcomes

  1. Perinatal Mortality

    Death of the fetus or neonate, including stillbirth and neonatal death.

    Time frame: From delivery up to 7 days postpartum

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Study locations

2 sites
  • Izmir city hospital
    Izmir, BAYRAKLI 34000, Turkey (Türkiye)
  • Izmir City Hospital
    Izmir, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 31784981 ↗
  • 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. PubMed 21154784 ↗

Individual participant data

Plan to share: No — NO,

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07190157
Lead sponsor
Izmir City Hospital
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Oct 2, 2025

Study contacts

Hale Ankara Aktaş, dr
Contact
haleankara@gmail.com
(0232) 955 05 00
Hakan Gölbasi
study director · Izmir City Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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