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RecruitingNCT07776314Updated Aug 20, 2026

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

An observational study in Pregnancy in Diabetes, Pregnancy and Pregnancy Outcomes, sponsored by Izmir Ataturk Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Izmir Ataturk Training and Research Hospital · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
128
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy in Diabetes
  • Pregnancy
  • Pregnancy Outcomes

Keywords

  • late-onset gestationel diabetes mellitus
  • benefits to screening for late -onset Gestational Diabetes Mellitus
  • Gestational Diabetes Mellitus
03

In context

Pregnancy in Diabetics

46 studies on the registry are indexed under Pregnancy in Diabetics; 16 are open to participants now.

This study's planned enrollment of 128 is below the median of 168 across 22 observational studies indexed under Pregnancy in Diabetics.

Browse Pregnancy in Diabetics studies →

Lead sponsor

Izmir Ataturk Training and Research Hospital is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population consists of pregnant women aged 18 to 45 years with confirmed singleton pregnancies between 32+0 and 34+6 weeks of gestation, presenting for routine antenatal care at the Obstetrics and Gynecology Outpatient Clinic of izmir katip çelebi atatürk Training and Research . Participants are selected from low-to-moderate risk antenatal admissions and will be followed prospectively through labor, delivery, and the postpartum/neonatal period to assess maternal and perinatal outcomes.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

: Voluntary agreement to participate in the study evidenced by signed written informed consent.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
128 participants (estimated)
Patient registry
No

Groups and cohorts

  • late-onset gestational diabetes mellitus

    In routine screening tests with Fasting Blood Glucose Test (FBG) at 32-34 weeks of gestation, late-onset GDM will be defined by FBG ≥5.1 mmol/L (92mg/dl), which is routinely checked in fasting blood.

  • control

    In routine screening tests with Fasting Blood Glucose Test (FBG) at 32-34 weeks of gestation, control group will be defined by FBG \<5.1 mmol/L (92mg/dl), which is routinely checked in fasting blood.

06

What researchers measure

Primary outcomes

  1. Rate of NICU admission

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

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

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

    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)

    Time frame: At birth

  3. Incidence of Hypertensive Disorders of Pregnancy (HDCP)

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

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

Secondary outcomes

  1. Mode of Delivery and Need for Emergency Cesarean Section

    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

    Time frame: At delivery

  2. Incidence of Shoulder Dystocia and Maternal Lacerations

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

    Time frame: At delivery

07

Study locations

1 of 1 sites recruiting
  • İzmir Katip Çelebi Atatürk Training and Research
    Izmir, Karabağlar 35360, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776314
Lead sponsor
Izmir Ataturk Training and Research Hospital
Responsible party
Yasin Ateş (assistant doctor, Izmir Ataturk Training and Research Hospital) — Principal investigator
First posted
Aug 20, 2026
Start date
Mar 13, 2025
Primary completion
Sep 1, 2026 (estimated)
Completion
Nov 10, 2026 (estimated)
Last update
Aug 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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