Maternal Physical Activity and Pregnancy Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03395652
Recruitment Status : Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : January 11, 2018
University of Belgrade
Information provided by (Responsible Party):
marija simic, Karolinska Institutet

Brief Summary:
The aim of this study is to investigate the impact of maternal physical activity during pregnancy on pregnancy outcome. Primary, fetal growth during pregnancy abd birth weight will be examined.

Condition or disease
Pregnancy Complications

Detailed Description:
During this study, the information on maternal physical activity will be collected and the impact on delivery and pregnancy complications as well as on neonatal complications will be evaluated. From the first visit at maternal care center, the information on socioeconomical and maternal characteristics will be collected. During pregnancy, fetal growth will be estimated by ultrasound. Physical activity will be measured using free app for measuring steps that mothers make during pregnancy. Using logistic regression, the impact of physical activity on pregnancy outcomes will be evaluated.

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Physical Activity and Pregnancy Outcome
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Fetal growth [ Time Frame: birth weight at birth ]
    Large for gestational age (LGA) small for gestational age (SGA)

Secondary Outcome Measures :
  1. Pregnancy complications [ Time Frame: during pregnancy ( 9 months from start) ]
    preeclampsia, diabetes, weight gain.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mothers included in the study live in Belgrade, Serbia and are pregnant during 2018. They are asked to participate in the study at first ultrasound examination at week 12-14.

Inclusion Criteria:

Healthy women with singleton pregnancies

Exclusion Criteria:

  • Twins pregnancies. Mothers with preexisting conditions. Malformations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03395652

Contact: Marija Simic, PhD +46707530508

Sponsors and Collaborators
Karolinska Institutet
University of Belgrade

Responsible Party: marija simic, Principal Investigator, Karolinska Institutet Identifier: NCT03395652     History of Changes
Other Study ID Numbers: Karolinskal
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by marija simic, Karolinska Institutet:
pregnancy, physical activity, fetal growth

Additional relevant MeSH terms:
Pregnancy Complications