Effect of Delivery Method on Umbilical Cord Metabolomic Analysis
1 other identifier
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFirst Submitted
Initial submission to the registry
July 17, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedJuly 30, 2025
July 1, 2025
11 months
July 17, 2025
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cord blood metabolomic analysis
Cord blood samples will be analysed via LC/MS analysis
From enrollment to birth. Cord Blood is taken during birth
Study Arms (2)
C/S
Babies delivered via C/S
Vaginal
Babies delivered vaginally
Eligibility Criteria
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.
You may qualify if:
- \) Female patient aged 18-35 2) Term pregnancy 3) Pregnant with follow-up
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aksaray University
Aksaray, 68110, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 39725908BACKGROUNDShokry 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.
PMID: 31201538BACKGROUNDRoss 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.
PMID: 33493154BACKGROUND
Biospecimen
Cord blood metabolome analysis
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
July 17, 2025
First Posted
July 30, 2025
Study Start
January 1, 2024
Primary Completion
December 1, 2024
Study Completion
July 1, 2025
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share