Glycemic Markers for Predicting Gestational Diabetes in Pregnant Women With Previous Bariatric Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorBurak Deniz Aydoğdu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of pregnant women aged 18-50 years with a history of bariatric surgery prior to conception who were followed at the Department of Obstetrics and Gynecology of Prof. Dr. Cemil Taşcıoğlu City Hospital. Eligible participants have documented glycemic parameters during the first and/or second trimester (including fasting plasma glucose, HbA1c, urine glucose and/or oral glucose tolerance test results) and available third trimester and/or delivery records. Only singleton pregnancies with complete clinical data are included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
84 Participants
are grouped into 2 trial groupsGroup A: OGTT Tolerant Group
Group B: OGTT Non-Tolerant Group
Trial outcomes
Primary outcomes
1
Development of Gestational Diabetes Mellitus (GDM)
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.
Time frame
Between 24 and 28 weeks of gestationSecondary outcomes
1
Polyhydramnios
Polyhydramnios diagnosed by ultrasound during pregnancy as documented in routine antenatal follow-up.
Time frame
Between 24 and 40 weeks of gestationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Burak Deniz Aydoğdu
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor institution
Source ClinicalTrials.gov