- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042349
Pregnant Elite Athletes and Pregnant Women Exercising With Moderate Intensity
April 6, 2022 updated by: Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
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.
Study Overview
Status
Not yet recruiting
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.
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jorunn Sundgot-Borgen, PhD
- Phone Number: +47 92241745
- Email: jorunn.sundgot-borgen@nih.no
Study Locations
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-
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Oslo, Norway, 0806
- The Norwegian School of Sport Sciences
-
Contact:
- Jorunn Sundgot-Borgen, PhD
- Phone Number: +47 92241745
- Email: jorunn.sundgot-borgen@nih.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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:
- Known illness or disease, which defines their pregnancy as a high-risk pregnancy
- Age >40 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Elite athletes
Pregnant female elite athletes
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Controls
Moderately physical active pregnant females
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Sponsors
Sponsors of the athletes
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Coaches/tema leaders
Coaches or team leaders of the atheltes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise
Time Frame: 5 minutes
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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.
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5 minutes
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Fertility and pregnancy related issues
Time Frame: 5 minutes
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Participants respond to open ended questions and questions with yes/no and multiple response options.
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5 minutes
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Nutrition
Time Frame: 5 minutes
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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.
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5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulsatility index
Time Frame: 15 minutes
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Ultrasound
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15 minutes
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Volume blood flow
Time Frame: 5 minutes
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Ultrasound
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5 minutes
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Heart rate frequency
Time Frame: 5 minutes
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Heart rate monitor
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5 minutes
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Body temperature
Time Frame: 5 minutes
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Thermometer
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5 minutes
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Blood pressure
Time Frame: 10 minutes
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Sphygmomanometer
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10 minutes
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Attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy
Time Frame: 5 minutes
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Participants respond to open ended questions and questions with yes/no and multiple response options.
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5 minutes
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Satisfaction with life
Time Frame: 1 minute
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Satisfaction with life scale.
5 items answered on a 7-point Likert scale, where higher sum score indicates higher satisfaction with life
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1 minute
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Beck's Depression Inventory (BDI-IA)
Time Frame: 1 minute
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Questionnaire where five questions are answered to on a 6-point Likert scale, with higher score indocates higher level of depressive symptoms.
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1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jorunn Sundgot-Borgen, PhD, The Norwegian School of Sport Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2022
Primary Completion (Anticipated)
December 31, 2026
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
September 4, 2021
First Submitted That Met QC Criteria
September 4, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 125635
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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