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

NCT07190157 | Not Yet Recruiting

• 1 other identifier: 2024/212
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fetal Growth Restriction; Perinatal Outcome; Pregnancy, High Risk

Keywords

Perinatal Outcome; Fetal Growth Restriction; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Perinatal Mortality

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

  From delivery up to 7 days postpartum

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (2)

Izmir city hospital

Izmir, BAYRAKLI, 34000, Turkey (Türkiye)

Location

Izmir City Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31784981 BACKGROUND

• 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.

  PMID: 21154784 BACKGROUND

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 Gölbasi

  Izmir City Hospital

  STUDY DIRECTOR

Central Study Contacts

Hale Ankara Aktaş, dr

CONTACT

(0232) 955 05 00; haleankara@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: October 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)