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Are There Any Clinical Benefits to Screening for Late -Onset Gestational Diabetes Mellitus?"

Are There Any Clinical Benefits to Screening for Late -Onset Gestational Diabetes Mellitus?"

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07776314
Enrollment
128
Registered
2026-08-20
Start date
2025-03-13
Completion date
2026-11-10
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Pregnancy in Diabetes, Pregnancy Outcomes

Keywords

late-onset gestationel diabetes mellitus, benefits to screening for late -onset Gestational Diabetes Mellitus, Gestational Diabetes Mellitus

Brief summary

This study aims to screen women who have a negative Gestational diabetes mellitus (GDM) result in routine screening tests or who have never had it with the Fasting Blood Glucose Test (FBG) at 32-34 weeks of gestation to diagnose late-onset GDM with routine FBG ≥5.1 mmol/L (92mg/dl) in fasting blood, and to investigate its connection with perinatal and maternal outcomes, hoping to inform about late-stage GDM.

Detailed description

Gestational diabetes mellitus (GDM) is defined as glucose tolerance disorder that first occurs during pregnancy.It is estimated that GDM occurs in approximately 10% of pregnancies. Gestational diabetes mellitus usually develops after the 24th week of pregnancy due to placental hormones blocking the effects of insulin (increasing insulin resistance).Hormonal changes in the body and placenta of pregnant women, such as estrogen, cortisol, and placental prolactin, together promote the development of insulin resistance. The risk of preeclampsia and premature birth is increased in expectant mothers diagnosed with gestational diabetes.In the newborn, it may cause macrosomia, neonatal hypoglycemia, jaundice, hypocalcemia, polycythemia, respiratory distress syndrome (RDS), congenital malformations and stillbirth. In Turkey, it is recommended that pregnant women have a GDM screening test at 24-28 weeks of gestation. However, pregnant women have prejudices against the test because there are people in their close circle, on the internet and on television screens who recommend not doing this test. Our aim in this study is to detect the pregnant women who do not have the sugar loading test and those whose fasting blood sugar is above 92mg/dl in their routine blood screenings at 32-34 weeks of pregnancy. In this way, the presence of late-term impaired sugar metabolism with high fasting blood sugar. We aim to detect whether it can be detected or not, and to inform and make recommendations to these pregnant patients about late-term high blood sugar and to investigate its consequences on the health of the mother and baby after birth.

Interventions

None listed

Sponsors

Izmir Ataturk Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Gestational Age: Confirmed singleton pregnancy between 32+0 and 34+6 weeks of gestation based on the last menstrual period (LMP) and/or first-trimester crown-rump length (CRL) ultrasound measurement. Follow-up: Intention and willingness to deliver at the study hospital and complete all planned follow-up visits until the end of the postpartum period. Informed Consent: Voluntary agreement to participate in the study evidenced by signed written informed consent.

Exclusion criteria

* Multifetal pregnancies (e.g., twins, triplets) Fetal Anomalies Pre-gestational Chronic Diseases Protocol Non-compliance / Loss to Follow-up Preterm Birth / Preterm Labor

Design outcomes

Primary

MeasureTime frameDescription
Rate of NICU admissionfrom birth up to hospital discharge assessed up to 7 days of lifethe proportion of newborns who require admission to the neonatal ıntensive care unit following delivery
Incidence of Macrosomia and Large for Gestational Age (LGA) InfantsAt birthThe proportion of neonates born with a birth weight of ≥4000 grams (macrosomia) or with a birth weight above the 90th percentile for their gestational age (LGA)
Incidence of Hypertensive Disorders of Pregnancy (HDCP)From enrollment (32-34 weeks of gestation) up to deliveryThe number of pregnant women who develop preeclampsia or gestational hypertension during the follow-up period

Secondary

MeasureTime frameDescription
Mode of Delivery and Need for Emergency Cesarean SectionAt deliveryThe distribution of delivery modes including normal spontaneous vaginal delivery (NSVD), elective cesarean section, and emergency cesarean section, as well as the need for labor induction
Incidence of Shoulder Dystocia and Maternal LacerationsAt deliveryThe percentage of deliveries complicated by shoulder dystocia, and the presence of maternal perineal lacerations

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026