NCT05042349

Brief Summary

The aim of this study is to 1. register possible changes to uteroplacental circulation in relation to physical tests, 2. to register energy and nutritional intake, relationship towards the body during pregnancy and during the early period after giving birth, 3. register the experience of guidance given related to exercise, nutrition, and recovery, 4. register elite athletes' experience of combining the role of being a mom and an elite athlete, and 5. register attitudes and reactions from the support system when it comes to being an elite athlete and being pregnant. Material and method: 30 pregnant female elite athletes and 30 moderately physically active pregnant women will be recruited for the completion of physical testing and questionnaires and questionnaires only, respectively. 20 national team leaders/coaches and 10 sponsors will be recruited for a semi-structured interview about attitudes, reactions and guidance towards athletes who become pregnant and still wish to continue their career as an athlete after pregnancy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Start

First participant enrolled

June 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

September 4, 2021

Last Update Submit

November 8, 2023

Conditions

Body ImagePhysical ActivityExerciseEnergy IntakeNutritional StatusPregnancy RelatedFetus RiskBlood FlowBody Temperature

Keywords

PregnancyElite athleteFetusPhysical healthMental health

Outcome Measures

Primary Outcomes (3)

  • Exercise

    Self-developed questions about exercise volume before, during, and after pregnancy. Participants respond to open ended questions and questions with yes/no and multiple response options.

    5 minutes

  • Fertility and pregnancy related issues

    Participants respond to open ended questions and questions with yes/no and multiple response options.

    5 minutes

  • Nutrition

    Questionnaire. Four days of dietary registration during, where participants respond both to questions with Likert scales, YES/NO, and multiple response options, 1st, 2nd, 3rd trimester, and 3 months after delivery.

    5 minutes

Secondary Outcomes (8)

  • Pulsatility index

    15 minutes

  • Volume blood flow

    5 minutes

  • Heart rate frequency

    5 minutes

  • Body temperature

    5 minutes

  • Blood pressure

    10 minutes

  • +3 more secondary outcomes

Study Arms (4)

Elite athletes

Pregnant female elite athletes

Controls

Moderately physical active pregnant females

Sponsors

Sponsors of the athletes

Coaches/tema leaders

Coaches or team leaders of the atheltes

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants need to be female only for the athletes and the control/reference group. For the sponsors, coaches and team leaders, there are no gender specifications or inclusion criteria.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample represents 1. pregnant female elite athletes, 2. pregnant females who are only moderately physically active, 3. the athletes sponsors, 4. the athletes coach/team leader.

You may qualify if:

  • Athletes: pregnant female pregnant elite athletes at a recruiting team, junior or senior, who represent athletes within endurance, weight sensitive, ball sports, and technical sports.
  • Controls/reference group: pregnant females who are moderately physically active.
  • For both groups: age 18-40 år.

You may not qualify if:

  • Known illness or disease, which defines their pregnancy as a high-risk pregnancy
  • Age \>40 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian school of sport sciences

Oslo, 0806, Norway

Location

MeSH Terms

Conditions

Motor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Officials

  • Jorunn Sundgot-Borgen, PhD

    The Norwegian School of Sport Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

September 4, 2021

First Posted

September 13, 2021

Study Start

June 1, 2020

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

NO(1)