CClinicalTrials.gg
WithdrawnNCT03395652Updated Nov 25, 2020

Maternal Physical Activity and Pregnancy Outcome

An observational study in Pregnancy Complications, sponsored by Karolinska Institutet. Withdrawn. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Karolinska Institutet · Observational

Why this study was withdrawn
technical problems
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
15 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy Complications

Keywords

  • pregnancy, physical activity, fetal growth
03

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
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

-

Exclusion Criteria:

  • Twins pregnancies. Mothers with preexisting conditions. Malformations.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Fetal growth

    Large for gestational age (LGA) small for gestational age (SGA)

    Time frame: birth weight at birth

Secondary outcomes

  1. Pregnancy complications

    preeclampsia, diabetes, weight gain.

    Time frame: during pregnancy ( 9 months from start)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03395652
Lead sponsor
Karolinska Institutet
Collaborators
University of Belgrade
Responsible party
marija simic (Principal Investigator, Karolinska Institutet) — Principal investigator
First posted
Jan 10, 2018
Start date
Jan 2018 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
May 2019 (estimated)
Last update
Nov 25, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion