NCT07093957

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

July 17, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

cord bloodmetabolomics

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

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

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)

Location

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: 39725908BACKGROUND
  • Shokry 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: 31201538BACKGROUND
  • Ross 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

Retention: SAMPLES WITH DNA

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

Locations