NCT06803979

Brief Summary

Labor itself can occur spontaneously vaginally, with the help of extraction methods, or via cesarean section. It can also be planned or awaited for the spontaneous onset of uterine contractions. Each method has its advantages and disadvantages regarding potential damage to the pelvic floor and its stability in vaginal delivery or extraction methods, or concerning the stability of the abdominal wall with subsequent wound healing after a cesarean section. The aim of the study is to retrospectively and prospectively determine the impact of the method of delivery on the performance of female athletes through a questionnaire study. Investigators would like to answer the question of whether cesarean delivery means a later return to training for athletes, whether pregnancy is problematic for female athletes in relation to their BMI, and whether pregnancy often signifies the end of a sports career for female athletes. The questionnaire also includes questions regarding overall women's health-menstrual cycle, incontinence, and mental health of female athletes. Prospectively, the questionnaire will be sent to all female athletes who meet representation limits once a year and for two years after retiring from the national team.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
166mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress8%
Mar 2025Jan 2040

First Submitted

Initial submission to the registry

January 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2025

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

14.8 years

First QC Date

January 20, 2025

Last Update Submit

March 16, 2025

Conditions

DeliveryPerformanceCaesarean SectionPregnancyAthletes

Keywords

deliveryperformancecaesarean sectionpregnancyathleteswomen health

Outcome Measures

Primary Outcomes (4)

  • Performance

    Best score will be used to compare performance of the athletes prior to delivery and after delivery

    2 years retrospectively and through study completion, an average of 5 years

  • Performance

    Best time will be used to compare performance of the athletes prior to delivery and after delivery

    2 years retrospectively and through study completion, an average of 5 years

  • Performance

    Most points scored will be used to compare performance of the athletes prior to delivery and after delivery

    2 years retrospectively and through study completion, an average of 5 years

  • Placement of athletes during competitions

    Best achievements according to athletes (for example 3rd place on Olympic Games) prior to delivery and after delivery

    Prior to delivery and 2 years after the delivery

Study Arms (3)

Retires elite athletes

Elite athletes with finished sport career

Elite athletes currently performing sport

Current elite athletes who are still doing sports and who will be asked about their career changes prospectively every year

General population

General population for comparing with previous groups

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsElite female athletes meeting representation limits and included in national teams organized under the Czech Olympic Committee and individual sports federations.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General young population for compering with the group of elite athletes which are meeting representation limits and included in national teams organized under the Czech Olympic Committee and individual sports federations.

You may qualify if:

  • \- Elite female athletes meeting representation limits and included in national teams organized under the Czech Olympic Committee and individual sports federations.

You may not qualify if:

  • \- Any male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 11000, Czechia

RECRUITING

Study Officials

  • Antonin Parizek, Prof., MUDr.

    General Faculty Hospital in Prague

    STUDY CHAIR

Central Study Contacts

Jan Zapletal, MUDr.

CONTACT

+420607882602honza.zaple@seznam.cz

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
100 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 31, 2025

Study Start

March 16, 2025

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

January 1, 2040

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Study protocol, Ethical approval, Informed consent

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1.6.2025-1.1.2030
Access Criteria
nternational Committee of Medical Journal Editors (ICMJE) and Ethical committee

Locations

CZ(1)