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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395652
Recruitment Status : Withdrawn (technical problems)
First Posted : January 10, 2018
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
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.

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Study Type : Observational
Actual Enrollment : 0 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.
Criteria

Inclusion Criteria:

Healthy women with singleton pregnancies

-

Exclusion Criteria:

  • Twins pregnancies. Mothers with preexisting conditions. Malformations.
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Responsible Party: marija simic, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03395652    
Other Study ID Numbers: Karolinskal
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020

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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:
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Pregnancy Complications