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临床试验/NCT07517406
NCT07517406招募中不适用

Predictive Value of Glycemic Markers for Gestational Diabetes Mellitus and Pregnancy Complications in Pregnant Women With Prior Bariatric Surgery Who Cannot Tolerate Oral Glucose Tolerance Testing

Burak Deniz Aydoğdu1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
Development of Gestational Diabetes Mellitus (GDM)

研究概览

简要总结

Gestational diabetes mellitus (GDM) is associated with significant maternal and fetal complications. The standard diagnostic test for GDM is the 75-gram oral glucose tolerance test (OGTT). However, pregnant women who have undergone bariatric surgery may not tolerate OGTT due to dumping syndrome and gastrointestinal side effects. This creates diagnostic challenges in this specific population.

The aim of this prospective observational study is to evaluate whether routinely measured glycemic markers, including fasting blood glucose, postprandial blood glucose, HbA1c, and urinary glucose levels, can predict the development of gestational diabetes mellitus and related pregnancy complications in women with prior bariatric surgery.

Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled and followed throughout pregnancy. The predictive value of glycemic markers for GDM, macrosomia, and polyhydramnios will be analyzed using multivariable logistic regression models.

This study aims to provide alternative diagnostic approaches for GDM screening in pregnant women who are unable to tolerate OGTT and to contribute to improving maternal and perinatal outcomes in this growing patient population.

详细描述

Gestational diabetes mellitus (GDM) is a common pregnancy complication associated with increased risks of maternal and perinatal morbidity. Early identification and appropriate management are essential to reduce adverse outcomes such as macrosomia, polyhydramnios, and cesarean delivery.

The standard diagnostic approach for GDM is the 75-gram oral glucose tolerance test (OGTT). However, women with prior bariatric surgery frequently experience intolerance to glucose loading due to dumping syndrome, which limits the reliability and feasibility of OGTT in this population. Consequently, alternative diagnostic strategies are required.

This prospective observational cohort study will be conducted at Prof. Dr. Cemil Taşcıoğlu City Hospital between February 2026 and December 2027. Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled during the first or second trimester. Participants will be categorized according to OGTT tolerance (tolerated vs. not tolerated/refused).

Baseline demographic characteristics including maternal age, gravidity, parity, obstetric history, and educational status will be recorded. Glycemic parameters assessed during routine antenatal follow-up will include fasting plasma glucose, postprandial glucose, HbA1c levels, and urinary glucose measurements. Second and third trimester ultrasound findings will be documented. Pregnancy outcomes including diagnosis of GDM, macrosomia (birth weight >4000 g), and polyhydramnios will be recorded.

The primary objective is to evaluate the predictive value of routine glycemic markers for GDM. Secondary objectives include assessing their association with macrosomia and polyhydramnios.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged 18-50 years
  • Singleton pregnancy
  • History of bariatric surgery prior to pregnancy
  • Followed at Prof. Dr. Cemil Taşcıoğlu City Hospital, Department of Obstetrics and Gynecology
  • Availability of glycemic parameters during early pregnancy (≤14 weeks) and/or between 24 and 28 weeks of gestation (fasting plasma glucose, HbA1c, urine glucose, and/or OGTT results if tolerated)
  • Availability of sonographic and clinical follow-up data between 28 weeks of gestation and delivery (up to 40 weeks)

排除标准

  • Age <18 years or >50 years
  • Multiple pregnancy
  • Presence of known chronic systemic disease (e.g., pregestational diabetes or endocrine disorders)
  • Incomplete or missing clinical data

研究组 & 干预措施

OGTT Tolerant Group

Pregnant women with a history of bariatric surgery who tolerate and complete the 75-gram oral glucose tolerance test during pregnancy.

OGTT Non-Tolerant Group

Pregnant women with a history of bariatric surgery who are unable to tolerate or refuse the 75-gram oral glucose tolerance test during pregnancy.

结局指标

主要结局

Development of Gestational Diabetes Mellitus (GDM)

时间窗: Between 24 and 28 weeks of gestation

Diagnosis of gestational diabetes mellitus based on standard 75-gram oral glucose tolerance test (OGTT) criteria or clinical diagnostic criteria in women unable to tolerate OGTT.

次要结局

  • Polyhydramnios(Between 24 and 40 weeks of gestation)

研究者

发起方
Burak Deniz Aydoğdu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Burak Deniz Aydoğdu

Specialist in Obstetrics and Gynecology

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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