Pregnant Elite Athletes and Pregnant Women Exercising With Moderate Intensity

Physical Activity Clinical Trial

Official title:

Pregnant Elite Athletes and Pregnant Women Exercising With Moderate Intensity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05042349
• Other study ID #: 125635
• Status: Withdrawn
• Start date: June 1, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Norway	The Norwegian school of sport sciences	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Fertility and pregnancy related issues	Participants respond to open ended questions and questions with yes/no and multiple response options.	5 minutes
Primary	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	Pulsatility index	Ultrasound	15 minutes
Secondary	Volume blood flow	Ultrasound	5 minutes
Secondary	Heart rate frequency	Heart rate monitor	5 minutes
Secondary	Body temperature	Thermometer	5 minutes
Secondary	Blood pressure	Sphygmomanometer	10 minutes
Secondary	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.	5 minutes
Secondary	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	1 minute
Secondary	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.	1 minute