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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04527731
Other study ID # BB002/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 25, 2020
Est. completion date May 30, 2022

Study information

Verified date December 2023
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being.


Description:

This study examines physical activity in different phases of pregnancy using accelerometry. The recruitment of pregnant women (N=30) in the first or second trimester (until week 23) will be realized over different channels (e.g, local newspapers, facebook, and leaflets in gynecological practices, shopping centers, and nurseries). Informed consent consists of: (i) activity recording over seven consecutive days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a cardiac ultrasound examination in the German Center for Cardiovascular Research (DZHK) - examination center. Participants are asked to wear an accelerometer at daytime, and over seven consecutive days, in trimester 1 (week 9-12), trimester 2 (week 23-26), and trimester 3 (week 36-39). Women who are attended the study in the first trimester wear the device up to three time whereas those who are attended the study in their second trimester wear the device up to twice. At the end of each measurement period women are invited to fill in a self-administered questionnaire. Also they are invited to participate in a cardiac ultrasound examination. Optionally, participants may receive feedback on their physical activity measured by accelerometer as well as about results of cardiac ultrasound examination upon completion of the study.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - current pregnancy, until pregnancy week 23 Exclusion Criteria: - cognitive impairment - insufficient language skills

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Accelerometry
Participants are asked to wear an accelerometer during the day for a period of seven days.

Locations

Country Name City State
Germany University Medicine Greifswald Greifswald

Sponsors (2)

Lead Sponsor Collaborator
University Medicine Greifswald Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Extent and intensity of physical activity between pregnancy week 9 and 12 Assessement via accelerometry between pregnancy week 9 and 12
Primary Extent and intensity of physical activity between pregnancy week 23 and 26 Assessement via accelerometry between pregnancy week 23 and 26
Primary Extent and intensity of physical activity between pregnancy week 36 and 39 Assessement via accelerometry between pregnancy week 36 and 39
Secondary Well-being Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. between pregnancy week 9 and 12
Secondary Well-being Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. between pregnancy week 23 and 26
Secondary Well-being Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. between pregnancy week 36 and 39
Secondary Mother-child bond Assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding. between pregnancy week 9 and 12
Secondary Mother-child bond Assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding. between pregnancy week 23 and 26
Secondary Mother-child bond assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding. between pregnancy week 36 and 39
Secondary Sociodemographics age, education ( between pregnancy week 9 and 12
Secondary Left ventricular muscle mass index Echocardiography will be done by qualified staff. Echocardiography between pregnancy week 9 and 12
Secondary Left ventricular muscle mass index Echocardiography will be done by qualified staff. cardiac ultrasound measurement between pregnancy week 23 and 26
Secondary Left ventricular muscle mass index Echocardiography will be done by qualified staff. Echocardiography between pregnancy week 36 and 39
Secondary Echocardiographic global strain, in % Echocardiography will be done by qualified staff. Echocardiography between pregnancy week 9 and 12
Secondary Echocardiographic global strain, in % The cardiac ultrasound examination will be conduced by qualified staff. cardiac ultrasound measurement between pregnancy week 23 and 26
Secondary Echocardiographic global strain, in % Echocardiography will be done by qualified staff. Echocardiography between pregnancy week 36 and 39
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