Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics

NCT06343974 | Recruiting

• 1 other identifier: 0843
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls. The main questions it aims to answer are:

• Are fetal liver ultrasound radiomic features reproducible?
• Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls? Participants will undergo ultrasound examination to collect ultrasound data for the analyses.

Conditions

Pregnancy in Diabetic; Diabetes Mellitus, Type 1

Keywords

ultrasonography; fetus; radiomics; hyperinsulinemia; liver; pregnancy

Outcome Measures

Primary Outcomes (1)

• Fetal liver ultrasound texture

  Fetal liver ultrasound texture is the collection of radiomic features that are extracted from the fetal liver ultrasound picture. The ultrasound pictures are acquired using transabdominal ultrasound. The radiomic features are extracted using conventional radiomics libraries e.g. pyradiomics.

  34+0 - 34+6 weeks of gestation

Secondary Outcomes (17)

• Birth weight in grams

  After delivery, up to 24 hours

• Birth weight centile

  After delivery, up to 24 hours

• Large for gestational age (LGA)

  After delivery, up to 24 hours

• Interventricular septum (IVS) width

  34+0 - 34+6 weeks of gestation

• Number of pregnancies with neonatal hypoglycemia

  During initial hospitalization, up to one week of age

Study Arms (2)

Type 1 diabetes

Pregnant woman with type 1 diabetes.

Healthy controls

Pregnant women with uncomplicated pregnancy and normal oral glucose tolerance test (OGTT).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women will be recruited at Turku University Hospital and Turku maternity welfare clinics during their routine pregnancy follow-up.

You may qualify if:

• Age between 18-45 years
• Capable to give an informed consent
• Singleton pregnancy
• Planning to deliver in Turku University Hospital
• Maternal BMI \< 40
• Gestational age should be confirmed by first trimester ultrasound
• Normal oral glucose tolerance test (OGTT) at 24-28 gestational weeks in controls

You may not qualify if:

• Major fetal chromosomal, genetic, or structural anomaly
• Fetal growth restriction, or birth weight \< 10th centile
• Birth weight \> 90th centile or polyhydramnios in the controls
• Non-reassuring fetal status requiring immediate treatment, or intrauterine fetal demise
• Verified fetal infection (e.g. cytomegalovirus, toxoplasma, hepatitis B and C), excluding bacterial infection due to intrapartum chorioamnionitis
• Placenta accreta spectrum disorder
• Major maternal medical condition requiring systemic pharmacological treatment, other than non-severe hypertension, hypothyroidism, asthma, mild psychiatric disorders, etc.
• Alcohol or tobacco use, or substance abuse in pregnancy

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (2)

Turku University Hospital

Turku, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Pregnancy in Diabetics; Diabetes Mellitus, Type 1; Hyperinsulinism

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mikael Huhtala, M.D., Ph.D.

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Huhtala, M.D., Ph.D.

CONTACT

+35823130000; misahu@utu.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, MD, PhD

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 3, 2024
• Study Start: October 11, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)