Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07776314

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

İzmir Katip Çelebi Atatürk Training and Research

Izmir, Karabağlar, 35360, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yasin Ateş

CONTACT

[email protected]

05343325171

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Rate of NICU admission

    Time frame: from birth up to hospital discharge assessed up to 7 days of life

    the proportion of newborns who require admission to the neonatal ıntensive care unit following delivery

  2. Incidence of Macrosomia and Large for Gestational Age (LGA) Infants

    Time frame: At birth

    The 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)

  3. Incidence of Hypertensive Disorders of Pregnancy (HDCP)

    Time frame: From enrollment (32-34 weeks of gestation) up to delivery

    The number of pregnant women who develop preeclampsia or gestational hypertension during the follow-up period

Secondary outcomes

  1. Mode of Delivery and Need for Emergency Cesarean Section

    Time frame: At delivery

    The 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

  2. Incidence of Shoulder Dystocia and Maternal Lacerations

    Time frame: At delivery

    The percentage of deliveries complicated by shoulder dystocia, and the presence of maternal perineal lacerations

Sponsors and collaborators

Lead sponsor

Izmir Ataturk Training and Research Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

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.

Published trials that share one or more normalized conditions with this study.