NCT07869004

Brief Summary

\*\*Brief Summary\*\* This study aims to evaluate the relationship between fetuin-B levels and intrauterine growth restriction (IUGR). Maternal serum fetuin-B levels will be compared between pregnant women with IUGR and those with appropriate fetal growth. The study will also assess whether fetuin-B levels are associated with clinical and obstetric characteristics, fetal growth parameters, and Doppler findings. The findings may provide further insight into the potential role of fetuin-B in the pathophysiology and clinical assessment of IUGR.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Oct 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

September 30, 2026

Last Update Submit

October 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal Serum Fetuin-B Level

    Maternal serum fetuin-B levels will be measured and compared between pregnant women with intrauterine growth restriction (IUGR) and pregnant women with appropriate-for-gestational-age (AGA) fetuses to evaluate the association between fetuin-B levels and IUGR.

    At the time of diagnosis of IUGR or at the corresponding gestational age in the control group. It is time between the 24th and 37th weeks of pregnancy.

Study Arms (2)

IUGR Group

Pregnant women diagnosed with intrauterine growth restriction (IUGR) according to established clinical and ultrasonographic criteria. Maternal serum fetuin-B levels, fetal growth parameters, and Doppler findings will be evaluated.

Other: measure fetuin b

Control Group (AGA)

Pregnant women with appropriate-for-gestational-age (AGA) fetuses and without evidence of intrauterine growth restriction. Maternal serum fetuin-B levels, fetal growth parameters, and Doppler findings will be evaluated.

Other: measure fetuin b

Interventions

No intervention is administered. This is an observational study in which maternal serum fetuin-B levels are measured and compared between pregnant women with intrauterine growth restriction (IUGR) and pregnant women with appropriate-for-gestational-age (AGA) fetuses.

Control Group (AGA)IUGR Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of pregnant women with singleton pregnancies who are evaluated during pregnancy at the participating center. The study group will include pregnant women diagnosed with intrauterine growth restriction (IUGR) according to predefined fetal growth and Doppler criteria. The control group will consist of pregnant women with appropriate-for-gestational-age (AGA) fetuses without evidence of IUGR. Maternal serum samples will be collected from participants to measure fetuin-B levels, and clinical, obstetric, fetal biometric, and Doppler parameters will be evaluated.

You may qualify if:

  • Pregnant women with a singleton pregnancy.
  • Gestational age between \[X and Y\] weeks at the time of enrollment.
  • Pregnant women diagnosed with intrauterine growth restriction (IUGR) according to predefined fetal growth and Doppler criteria for the study group.
  • Pregnant women with an appropriate-for-gestational-age (AGA) fetus for the control group.
  • Availability of maternal serum samples for fetuin-B measurement.
  • Provision of written informed consent to participate in the study.

You may not qualify if:

  • Multiple pregnancy.
  • Major fetal congenital or chromosomal anomalies.
  • Known maternal chronic diseases that may significantly affect fetal growth or fetuin-B levels, such as pre-existing diabetes mellitus, chronic hypertension, renal disease, or autoimmune disease.
  • Maternal infection or other conditions associated with fetal growth restriction, when clinically relevant.
  • Placental abnormalities that may independently affect fetal growth.
  • Pregnancies with incomplete clinical, laboratory, ultrasonographic, or Doppler data.
  • Inability or unwillingness to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz technical university, school of medicine

Akçaabat, Trabzon, (530) 548 04 97, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal peripheral venous blood samples will be collected from pregnant women for the assessment of fetuin-B levels and, if applicable, molecular/genetic analyses. The samples contain genomic DNA derived from maternal blood cells.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 9, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

No. Individual participant-level data will not be made available to other researchers.

Locations