MetabolomicsNCT07093957
Effect of Delivery Method on Umbilical Cord Metabolomic Analysis
An observational study of Metabolomics and Cord Blood, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Birth type is closely linked to fetal and maternal stress responses. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Metabolomics, Cord Blood
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jul 2025
- How long will I take part?
- 1 Week
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population included pregnant women aged between 18 and 35 years who were regularly followed during their pregnancy and delivered at term. Women with a diagnosis of diabetes mellitus or hypertension either before or during pregnancy were excluded from the study. Additionally, pregnancies with multiple fetuses, non-elective cesarean sections, intrauterine growth restriction, or fetal congenital anomalies (or suspicion thereof) were not included. The study aimed to ensure a homogeneous and healthy sample to evaluate neonatal stress responses in relation to the mode of delivery.
Who may be able to join
- 1) Female patient aged 18-35 2) Term pregnancy 3) Pregnant with follow-up
Who cannot join
- 1) Having been diagnosed with diabetes mellitus before or during pregnancy 2) Having been diagnosed with hypertension before or during pregnancy 3) Non-singleton pregnancy 4) Non-elective C/S 5) Fetal intrauterine growth restriction 6) Mothers and their babies with a fetal birth anomaly or suspected birth anomaly will not be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Birth type is closely linked to fetal and maternal stress responses. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level.
Read the detailed description
Birth type is closely linked to fetal and maternal stress responses. Previous studies have found higher levels of hormones associated with stress responses in mothers who delivered vaginally compared to those who delivered by cesarean section (C/S). Similarly, differences in markers assessing stress responses in newborns have been observed based on delivery method. However, the literature lacks sufficient studies on low-molecular-weight metabolites, which reveal the metabolic status of newborns.
Metabolomic profiling studies are introductory studies that provide comprehensive information about cell or organism metabolism. They contribute to research in many areas of medicine. In perinatology, metabolomic profiling studies have been conducted on topics such as neural tube defects, intrauterine growth restriction, and maternal diabetes. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level.
- Conditions
- Metabolomics, Cord Blood
- Keywords
- cord blood, metabolomics
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 |
|---|---|---|
| C/S | Babies delivered via C/S | |
| Vaginal | Babies delivered vaginally |
What is being measured
The primary outcome is the main question the study is designed to answer.
cord blood metabolomic analysis
Cord blood samples will be analysed via LC/MS analysis
Measured: From enrollment to birth. Cord Blood is taken during birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MetabolomicsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Guran, MD, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093957
- Sponsor's protocol ID
- CORD_omics
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Ni Y, Meng Y, Zeng X, He X, Zhang L, Zhang J. Integrated proteomics and metabolomics network analysis across different delivery modes in human pregnancy: a pilot study. BMC Pregnancy Childbirth. 2024 Dec 26;24(1):868. doi: 10.1186/s12884-024-07097-4.
PubMed 39725908Shokry E, Marchioro L, Uhl O, Bermudez MG, Garcia-Santos JA, Segura MT, Campoy C, Koletzko B. Investigation of the impact of birth by cesarean section on fetal and maternal metabolism. Arch Gynecol Obstet. 2019 Sep;300(3):589-600. doi: 10.1007/s00404-019-05213-w. Epub 2019 Jun 14.
PubMed 31201538Ross AB, Barman M, Hartvigsson O, Lundell AC, Savolainen O, Hesselmar B, Wold AE, Sandberg AS. Umbilical cord blood metabolome differs in relation to delivery mode, birth order and sex, maternal diet and possibly future allergy development in rural children. PLoS One. 2021 Jan 25;16(1):e0242978. doi: 10.1371/journal.pone.0242978. eCollection 2021.
PubMed 33493154
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Delivery Method on Umbilical Cord Metabolomic Analysis
- ClinicalTrials.gov ID
- NCT07093957
- Acronym / sponsor ID
- CORD_omics
- Conditions
- Metabolomics, Cord Blood
- Keywords
- cord blood, metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 30 Jul 2025 (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.
Birth type is closely linked to fetal and maternal stress responses. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level.
Detailed description
Birth type is closely linked to fetal and maternal stress responses. Previous studies have found higher levels of hormones associated with stress responses in mothers who delivered vaginally compared to those who delivered by cesarean section (C/S). Similarly, differences in markers assessing stress responses in newborns have been observed based on delivery method. However, the literature lacks sufficient studies on low-molecular-weight metabolites, which reveal the metabolic status of newborns.
Metabolomic profiling studies are introductory studies that provide comprehensive information about cell or organism metabolism. They contribute to research in many areas of medicine. In perinatology, metabolomic profiling studies have been conducted on topics such as neural tube defects, intrauterine growth restriction, and maternal diabetes. In this study, we aimed to examine the effects of delivery method on the stress response in newborns at the metabolite level.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C/S | – | –Babies delivered via C/S |
| Vaginal | – | –Babies delivered vaginally |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population included pregnant women aged between 18 and 35 years who were regularly followed during their pregnancy and delivered at term. Women with a diagnosis of diabetes mellitus or hypertension either before or during pregnancy were excluded from the study. Additionally, pregnancies with multiple fetuses, non-elective cesarean sections, intrauterine growth restriction, or fetal congenital anomalies (or suspicion thereof) were not included. The study aimed to ensure a homogeneous and healthy sample to evaluate neonatal stress responses in relation to the mode of delivery.
Key inclusion criteria (1 listed)
- 1) Female patient aged 18-35 2) Term pregnancy 3) Pregnant with follow-up
Key exclusion criteria (1 listed)
- 1) Having been diagnosed with diabetes mellitus before or during pregnancy 2) Having been diagnosed with hypertension before or during pregnancy 3) Non-singleton pregnancy 4) Non-elective C/S 5) Fetal intrauterine growth restriction 6) Mothers and their babies with a fetal birth anomaly or suspected birth anomaly will not be included in this study.
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
cord blood metabolomic analysis
Time frame: From enrollment to birth. Cord Blood is taken during birth
Cord blood samples will be analysed via LC/MS analysis
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 30 Jul 2025.
- Results publication: PubMed 39725908Huang Y, Ni Y, Meng Y, Zeng X, He X, Zhang L, Zhang J. Integrated proteomics and metabolomics network analysis across different delivery modes in human pregnancy: a pilot study. BMC Pregnancy Childbirth. 2024 Dec 26;24(1):868. doi: 10.1186/s12884-024-07097-4.
- Results publication: PubMed 31201538Shokry E, Marchioro L, Uhl O, Bermudez MG, Garcia-Santos JA, Segura MT, Campoy C, Koletzko B. Investigation of the impact of birth by cesarean section on fetal and maternal metabolism. Arch Gynecol Obstet. 2019 Sep;300(3):589-600. doi: 10.1007/s00404-019-05213-w. Epub 2019 Jun 14.
- Results publication: PubMed 33493154Ross AB, Barman M, Hartvigsson O, Lundell AC, Savolainen O, Hesselmar B, Wold AE, Sandberg AS. Umbilical cord blood metabolome differs in relation to delivery mode, birth order and sex, maternal diet and possibly future allergy development in rural children. PLoS One. 2021 Jan 25;16(1):e0242978. doi: 10.1371/journal.pone.0242978. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Metabolomics
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Recruiting
Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
Alzheimer Disease
Not yet recruitingObservational study
LEANDIP: Lean Diabetes in Asian Indians
Lean Diabetes Mellitus, Type 2 Diabetes
Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
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 Metabolomics and Cord Blood, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 1 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: finished, as of the sponsor's last update on 30 Jul 2025. 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?
cord blood metabolomic analysis (time frame: From enrollment to birth. Cord Blood is taken during birth). 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 NCT07093957, which also lists 3 linked publications.
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 30 Jul 2025.