- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06826508
Modes of Delivery Impact Maternal Oxidative Stress Biomarkers and Dynamic Thiol Disulphide Homeostasis
February 12, 2025 updated by: Hasan Basri Savas, Mardin Artuklu University
Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Antalya, Turkey
- Alanya Training and Research Hospital Gynecology and Obstetrics Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Pregnant women
Description
Inclusion Criteria:
For VD group:
- Women with spontaneous uncomplicated vaginal delivery
- Women who were in the 38th week and vertex presentation and whose contractions had started naturally.
For CS group:
• Women in their 38th week of pregnancy who delivered by elective CS without uterine contractions
Exclusion Criteria:
- Participants who were smokers
- Participants who had a non-optimal pre-pregnancy body mass index
- Systemic diseases such as diabetes mellitus and gestational hypertension.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
vaginal delivery
35 women who had spontaneous vaginal deliveries
|
|
cesarean section
23 women who had elective cesarean sections without labor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Total antioxidation state (μmol Trolox equivalent/ L),
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Total oxidation status(μmol H2O2 equivalent/L)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Oxidative stress index (arbitrary unit)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Disulfide (-S-S-) (µmol / L) / alb (g / l)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Total thiol (µmol / L)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Native thiol (µmol / L) / alb (g / l)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Ischemia modified albumin (U/L)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Paroxanase (U/L)
|
From January 2021 to August 2021
|
|
Oxidative stress markers
Time Frame: From January 2021 to August 2021
|
Arylesterase (Ku/l)
|
From January 2021 to August 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
February 7, 2025
First Submitted That Met QC Criteria
February 12, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 12, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 18.09.2020 / 23-9
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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