Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM

NCT ID: NCT05392231

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-10

Study Completion Date

2022-05-10

Brief Summary

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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).

Detailed Description

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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).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.

Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Maternal age between 18 and 42 years
* Gestational age between 20 and 28 weeks

Exclusion Criteria

* Multiple pregnancies
* Pregestational diabetes
* Fetal congenital malformations
* Placental and amniotic fluid abnormalities
* Preeclampsia
* Severe systemic disease
* Long-term systemic drug usage
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haseki Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 36436013 (View on PubMed)

Other Identifiers

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05-2022

Identifier Type: -

Identifier Source: org_study_id

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