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WithdrawnNCT05042349Updated Nov 13, 2023

Pregnant Elite Athletes and Pregnant Women Exercising With Moderate Intensity

An observational study in Body Image, Physical Activity and Exercise, sponsored by Norwegian School of Sport Sciences. Withdrawn at 1 site in Norway. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Norwegian School of Sport Sciences · Observational

Why this study was withdrawn
no funding
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

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: It is expected that we can include 30 pregnant female elite athletes for the physiological testing who also will complete the questionnaires included in the study. In addition, 30 moderately physically active pregnant women will be recruited for the completion of the questionnaires only. Both groups answer questions related to exercise, pregnancy related issues, nutrition and their relationship towards their body. To obtain enough participants, data collection will continue for five years. During the same period, 20 national team leaders/coaches and 10 sponsors will be recruited for a semi-structured interview. The physiological testing will be conducted during the 23-29th week of pregnancy. The athletes will conduct a running test and resistance tests in the lab. The following measures will be registered: pulsatility index (PI) and volume blood flow in both uterine arteries, 2. the fetus' pulsatility index (PI) in the umbilical cord artery and heart rate frequency, 3. body temperature, heart rate, blood pressure and saturation in the mother during rest and during physical exertion. Data on gestational development and birth will be collected based on information given by the participant herself and by birth records and health records. Coaches/leaders and sponsors will in their interview, answer to questions related to attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy.

02

Conditions studied

  • Body Image
  • Physical Activity
  • Exercise
  • Energy Intake
  • Nutritional Status
  • Pregnancy Related
  • Fetus Risk
  • Blood Flow
  • Body Temperature

Keywords

  • Pregnancy
  • Elite athlete
  • Fetus
  • Physical health
  • Mental health
03

In context

Lead sponsor

Norwegian School of Sport Sciences is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known illness or disease, which defines their pregnancy as a high-risk pregnancy
  • Age >40 years old.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

  2. Fertility and pregnancy related issues

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

    Time frame: 5 minutes

  3. 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.

    Time frame: 5 minutes

Secondary outcomes

  1. Pulsatility index

    Ultrasound

    Time frame: 15 minutes

  2. Volume blood flow

    Ultrasound

    Time frame: 5 minutes

  3. Heart rate frequency

    Heart rate monitor

    Time frame: 5 minutes

  4. Body temperature

    Thermometer

    Time frame: 5 minutes

  5. Blood pressure

    Sphygmomanometer

    Time frame: 10 minutes

  6. Attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy

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

    Time frame: 5 minutes

  7. Satisfaction with life

    Satisfaction with life scale. 5 items answered on a 7-point Likert scale, where higher sum score indicates higher satisfaction with life

    Time frame: 1 minute

  8. Beck's Depression Inventory (BDI-IA)

    Questionnaire where five questions are answered to on a 6-point Likert scale, with higher score indocates higher level of depressive symptoms.

    Time frame: 1 minute

07

Study locations

1 site
  • The Norwegian school of sport sciences
    Oslo, 0806, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05042349
Lead sponsor
Norwegian School of Sport Sciences
Responsible party
Professor Jorunn Sundgot-Borgen (Professor, Norwegian School of Sport Sciences) — Principal investigator
First posted
Sep 13, 2021
Start date
Jun 1, 2020 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Nov 13, 2023

Study contacts

Jorunn Sundgot-Borgen, PhD
principal investigator · The Norwegian School of Sport Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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