Vaginal DeliveryNCT06826508
Modes of Delivery Impact Maternal Oxidative Stress Biomarkers and Dynamic Thiol Disulphide Homeostasis
An observational study of Vaginal Delivery and Cesarian Section, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Vaginal Delivery, Cesarian Section, Oxidative Stress
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2021to 1 Dec 2021
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women
Who may be able to join
- 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
Who cannot join
- Participants who were smokers
- Participants who had a non-optimal pre-pregnancy body mass index
- Systemic diseases such as diabetes mellitus and gestational hypertension.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Training and Research Hospital Gynecology and Obstetrics Department
Antalya
About this study
Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis
- Conditions
- Vaginal Delivery, Cesarian Section, Oxidative Stress
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 |
|---|---|---|
| vaginal delivery | 35 women who had spontaneous vaginal deliveries | |
| cesarean section | 23 women who had elective cesarean sections without labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers
Total antioxidation state (μmol Trolox equivalent/ L),
Measured: From January 2021 to August 2021
Oxidative stress markers
Total oxidation status(μmol H2O2 equivalent/L)
Measured: From January 2021 to August 2021
Oxidative stress markers
Oxidative stress index (arbitrary unit)
Measured: From January 2021 to August 2021
Oxidative stress markers
Disulfide (-S-S-) (µmol / L) / alb (g / l)
Measured: From January 2021 to August 2021
Oxidative stress markers
Total thiol (µmol / L)
Measured: From January 2021 to August 2021
Oxidative stress markers
Native thiol (µmol / L) / alb (g / l)
Measured: From January 2021 to August 2021
Oxidative stress markers
Ischemia modified albumin (U/L)
Measured: From January 2021 to August 2021
Oxidative stress markers
Paroxanase (U/L)
Measured: From January 2021 to August 2021
Oxidative stress markers
Arylesterase (Ku/l)
Measured: From January 2021 to August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start3 Jan 2021
- Primary completion30 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University
- Responsible party
- Principal investigator, Hasan Basri Savas, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826508
- Sponsor's protocol ID
- 18.09.2020 / 23-9
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modes of Delivery Impact Maternal Oxidative Stress Biomarkers and Dynamic Thiol Disulphide Homeostasis
- ClinicalTrials.gov ID
- NCT06826508
- Acronym / sponsor ID
- 18.09.2020 / 23-9
- Conditions
- Vaginal Delivery, Cesarian Section, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Feb 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.
Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal delivery | – | –35 women who had spontaneous vaginal deliveries |
| cesarean section | – | –23 women who had elective cesarean sections without labor |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- Women with spontaneous uncomplicated vaginal delivery
- Women who were in the 38th week and vertex presentation and whose contractions had started naturally.
- Women in their 38th week of pregnancy who delivered by elective CS without uterine contractions
Key exclusion criteria (3 listed)
- Participants who were smokers
- Participants who had a non-optimal pre-pregnancy body mass index
- Systemic diseases such as diabetes mellitus and gestational hypertension.
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
Oxidative stress markers
Time frame: From January 2021 to August 2021
Total antioxidation state (μmol Trolox equivalent/ L),
Oxidative stress markers
Time frame: From January 2021 to August 2021
Total oxidation status(μmol H2O2 equivalent/L)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Oxidative stress index (arbitrary unit)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Disulfide (-S-S-) (µmol / L) / alb (g / l)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Total thiol (µmol / L)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Native thiol (µmol / L) / alb (g / l)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Ischemia modified albumin (U/L)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Paroxanase (U/L)
Oxidative stress markers
Time frame: From January 2021 to August 2021
Arylesterase (Ku/l)
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 Feb 2025.
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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 Vaginal Delivery and Cesarian Section, run by Mardin Artuklu University 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 5 inclusion and 3 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 Feb 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?
Oxidative stress markers (time frame: From January 2021 to August 2021). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2025.