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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exercise
Time Frame: 5 minutes
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
Time Frame: 5 minutes
Participants respond to open ended questions and questions with yes/no and multiple response options.
5 minutes
Nutrition
Time Frame: 5 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulsatility index
Time Frame: 15 minutes
Ultrasound
15 minutes
Volume blood flow
Time Frame: 5 minutes
Ultrasound
5 minutes
Heart rate frequency
Time Frame: 5 minutes
Heart rate monitor
5 minutes
Body temperature
Time Frame: 5 minutes
Thermometer
5 minutes
Blood pressure
Time Frame: 10 minutes
Sphygmomanometer
10 minutes
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
Participants respond to open ended questions and questions with yes/no and multiple response options.
5 minutes
Satisfaction with life
Time Frame: 1 minute
Satisfaction with life scale. 5 items answered on a 7-point Likert scale, where higher sum score indicates higher satisfaction with life
1 minute
Beck's Depression Inventory (BDI-IA)
Time Frame: 1 minute
Questionnaire where five questions are answered to on a 6-point Likert scale, with higher score indocates higher level of depressive symptoms.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian School of Sport Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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