NCT06826508

Brief Summary

Modes of delivery impact maternal oxidative stress biomarkers and dynamic thiol disulphide homeostasis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

February 7, 2025

Last Update Submit

February 12, 2025

Conditions

Vaginal DeliveryCesarian SectionOxidative Stress

Outcome Measures

Primary Outcomes (9)

  • Oxidative stress markers

    Total antioxidation state (μmol Trolox equivalent/ L),

    From January 2021 to August 2021

  • Oxidative stress markers

    Total oxidation status(μmol H2O2 equivalent/L)

    From January 2021 to August 2021

  • Oxidative stress markers

    Oxidative stress index (arbitrary unit)

    From January 2021 to August 2021

  • Oxidative stress markers

    Disulfide (-S-S-) (µmol / L) / alb (g / l)

    From January 2021 to August 2021

  • Oxidative stress markers

    Total thiol (µmol / L)

    From January 2021 to August 2021

  • Oxidative stress markers

    Native thiol (µmol / L) / alb (g / l)

    From January 2021 to August 2021

  • Oxidative stress markers

    Ischemia modified albumin (U/L)

    From January 2021 to August 2021

  • Oxidative stress markers

    Paroxanase (U/L)

    From January 2021 to August 2021

  • Oxidative stress markers

    Arylesterase (Ku/l)

    From January 2021 to August 2021

Study Arms (2)

vaginal delivery

35 women who had spontaneous vaginal deliveries

cesarean section

23 women who had elective cesarean sections without labor

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women

You may qualify if:

  • 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

You may not qualify if:

  • Participants who were smokers
  • Participants who had a non-optimal pre-pregnancy body mass index
  • Systemic diseases such as diabetes mellitus and gestational hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Training and Research Hospital Gynecology and Obstetrics Department

Antalya, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 14, 2025

Study Start

January 3, 2021

Primary Completion

August 30, 2021

Study Completion

December 1, 2021

Last Updated

February 14, 2025

Record last verified: 2025-01

Locations

TU(1)