Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM
PS-GDM-2022
1 other identifier
observational
109
1 country
1
Brief Summary
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2022
CompletedFirst Submitted
Initial submission to the registry
May 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedJune 1, 2022
May 1, 2022
3 months
May 22, 2022
May 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Early prediction of gestational diabetes
Early prediction of gestational diabetes by the fetal pancreas measurement with ultrasound and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase measured with ELISA
Two months
Eligibility Criteria
With a design of prospective observational study, this research was carried out in the Perinatology Clinic of Haseki Hospital, affiliated with the University of Health Sciences, in Istanbul, between September 2021 and April 2022, following the approval of the local ethics committee (date: February 09, 2022, Registry No: 05-2022) and the valid Helsinki Declaration. After all the objectives of this work and context of all the procedures that could be undertaken were properly explained to each pregnant woman, the participant was requested to sign an informed written consent form.
You may qualify if:
- Maternal age between 18 and 42 years
- Gestational age between 20 and 28 weeks
You may not qualify if:
- Multiple pregnancies
- Pregestational diabetes
- Fetal congenital malformations
- Placental and amniotic fluid abnormalities
- Preeclampsia
- Severe systemic disease
- Long-term systemic drug usage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haseki Training and Research Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
Guleroglu FY, Ozmen AB, Bakirci IT, Dogu SY, Yilmaz I, Cetin A. Fetal pancreas size and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase provide no potential for early prediction of gestational diabetes mellitus. Arch Gynecol Obstet. 2023 Nov;308(5):1505-1514. doi: 10.1007/s00404-022-06860-2. Epub 2022 Nov 27.
PMID: 36436013DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2022
First Posted
May 26, 2022
Study Start
February 10, 2022
Primary Completion
April 30, 2022
Study Completion
May 10, 2022
Last Updated
June 1, 2022
Record last verified: 2022-05