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NCT Number: NCT05392231

Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM

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).

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Early prediction of gestational diabetes

    Time frame: Two months

    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

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus

Acronym: PS-GDM-2022

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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