Pregnancy in DiabetesNCT07776314
Are There Any Clinical Benefits to Screening for Late -Onset Gestational Diabetes Mellitus?"
An observational study of Pregnancy in Diabetes and Pregnancy, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Diabetes, Pregnancy, Pregnancy Outcomes
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2025to 10 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Multifetal pregnancies (e.g., twins, triplets) Fetal Anomalies Pre-gestational Chronic Diseases Protocol Non-compliance / Loss to Follow-up Preterm Birth / Preterm Labor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İzmir Katip Çelebi Atatürk Training and Research
Izmir, Karabağlar, 35360
Yasin Ateş, 05343325171, yasinates48@gmail.com
About this study
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.
- Conditions
- Pregnancy in Diabetes, Pregnancy, Pregnancy Outcomes
- Keywords
- late-onset gestationel diabetes mellitus, benefits to screening for late -onset Gestational Diabetes Mellitus, Gestational Diabetes Mellitus
- Medical subject headings
- Pregnancy in Diabetics, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of NICU admission
the proportion of newborns who require admission to the neonatal ıntensive care unit following delivery
Measured: from birth up to hospital discharge assessed up to 7 days of life
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)
Measured: At birth
Incidence of Hypertensive Disorders of Pregnancy (HDCP)
The number of pregnant women who develop preeclampsia or gestational hypertension during the follow-up period
Measured: From enrollment (32-34 weeks of gestation) up to delivery
Secondary outcomes (2)
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
Measured: At delivery
Incidence of Shoulder Dystocia and Maternal Lacerations
The percentage of deliveries complicated by shoulder dystocia, and the presence of maternal perineal lacerations
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start13 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Ateş, Izmir Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776314
- Sponsor's protocol ID
- 2024-SAEK-0464
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are There Any Clinical Benefits to Screening for Late -Onset Gestational Diabetes Mellitus?"
- ClinicalTrials.gov ID
- NCT07776314
- Acronym / sponsor ID
- 2024-SAEK-0464
- Conditions
- Pregnancy in Diabetes, Pregnancy, Pregnancy Outcomes
- Keywords
- late-onset gestationel diabetes mellitus, benefits to screening for late -onset Gestational Diabetes Mellitus, Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Multifetal pregnancies (e.g., twins, triplets) Fetal Anomalies Pre-gestational Chronic Diseases Protocol Non-compliance / Loss to Follow-up Preterm Birth / Preterm Labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
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
2 secondary outcomes
Mode of Delivery and Need for Emergency Cesarean Section
Time frame: At delivery
Incidence of Shoulder Dystocia and Maternal Lacerations
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
İzmir Katip Çelebi Atatürk Training and Research
Izmir, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy in Diabetes and Pregnancy, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of NICU admission (time frame: from birth up to hospital discharge assessed up to 7 days of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.