Infants of Diabetic MothersNCT07765784
Placental Weight in Infants of Gestational Diabetic Mothers
An observational study of Infants of Diabetic Mothers and Placenta, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective cross-sectional study examined the relationship between placental weight and early neonatal outcomes, such as blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to mothers with gestational diabetes. Read more about this study
- Who is it for?
- Ages 0 hours to 2 days
- Conditions the study is for
- Infants of Diabetic Mothers, Placenta, Hypoglycaemia
- What is being tested?
- Blood Glucose Level
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Jan 2026
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 hours to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants who are born to gestational diabetic mothers
Who may be able to join
- Infants born at the study center
- a gestational age of ≥35 weeks
- singleton pregnancies
- maternal ages between 18 and 35 years
Who cannot join
- preterm birth (<35 weeks of gestation)
- referral to another center after delivery
- presence of chromosomal and/or congenital anomalies
- maternal conditions other than gestational diabetes
- lack of parental consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences GOP Training and Research Hospital
Istanbul, Gaziosmanpasa, 34020
About this study
Official title: Placental Weight and Placental Weight-to-Birth Weight Ratio as Predictors of Early Neonatal Glycemic Profiles in Infants Born to Mothers With Gestational Diabetes
This prospective cross-sectional study examined the relationship between placental weight and early neonatal outcomes, such as blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to mothers with gestational diabetes. levels in the first 24 hours of life and early neonatal morbidities, in infants born to mothers with gestational diabetes.
Read the detailed description
This prospective cross-sectional study investigated the association between placental weight and early neonatal outcomes, including blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to mothers with gestational diabetes.
- Conditions
- Infants of Diabetic Mothers, Placenta, Hypoglycaemia
- Being tested
- Blood Glucose Level
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Glucose LevelDiagnostic test
Blood glucose levels of the infants enrolled in the study were checked at the first 30 minutes after birth and at the end of 1,2, 6,24 hours of life.
| Study group | Role | What they receive |
|---|---|---|
| Infants of Gestational Diabetic Mothers | The indants whose mothers has gestational diabetes Receives: Diagnostic Test: Blood Glucose Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
If the infants had a blood glucose level below the predefined limits, they would be included in the hypoglycemia group.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Apr 2025
- Primary completion29 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infants of Diabetic MothersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765784
- Sponsor's protocol ID
- 2025/24
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sathasivam R, Selliah P, Sivalingarajah R, Mayorathan U, Munasinghe BM. Placental weight and its relationship with the birth weight of term infants and body mass index of the mothers. J Int Med Res. 2023 May;51(5):3000605231172895. doi: 10.1177/03000605231172895.
PubMed 37194202
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Weight and Placental Weight-to-Birth Weight Ratio as Predictors of Early Neonatal Glycemic Profiles in Infants Born to Mothers With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07765784
- Acronym / sponsor ID
- 2025/24
- Conditions
- Infants of Diabetic Mothers, Placenta, Hypoglycaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 29 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 14 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 prospective cross-sectional study examined the relationship between placental weight and early neonatal outcomes, such as blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to mothers with gestational diabetes. levels in the first 24 hours of life and early neonatal morbidities, in infants born to mothers with gestational diabetes.
Detailed description
This prospective cross-sectional study investigated the association between placental weight and early neonatal outcomes, including blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to mothers with gestational diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants of Gestational Diabetic Mothers | – | Diagnostic Test: Blood Glucose LevelThe indants whose mothers has gestational diabetes |
Who may qualify
- Ages
- 0 hours to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants who are born to gestational diabetic mothers
Key inclusion criteria (4 listed)
- Infants born at the study center
- a gestational age of ≥35 weeks
- singleton pregnancies
- maternal ages between 18 and 35 years
Key exclusion criteria (5 listed)
- preterm birth (<35 weeks of gestation)
- referral to another center after delivery
- presence of chromosomal and/or congenital anomalies
- maternal conditions other than gestational diabetes
- lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Glucose LevelBlood glucose levels of the infants enrolled in the study were checked at the first 30 minutes after birth and at the end of 1,2, 6,24 hours of life. | Diagnostic test | Infants of Gestational Diabetic Mothers |
Primary outcome
Hypoglycemia
Time frame: 8 months
If the infants had a blood glucose level below the predefined limits, they would be included in the hypoglycemia group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 37194202Sathasivam R, Selliah P, Sivalingarajah R, Mayorathan U, Munasinghe BM. Placental weight and its relationship with the birth weight of term infants and body mass index of the mothers. J Int Med Res. 2023 May;51(5):3000605231172895. doi: 10.1177/03000605231172895.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Infants of Diabetic Mothers and Placenta, run by Kanuni Sultan Suleyman 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07765784, which also lists 1 linked publication.
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 14 Aug 2026.