Pregnancy ComplicationsNCT03395652
Maternal Physical Activity and Pregnancy Outcome
An observational study of Pregnancy Complications, run by Karolinska Institutet.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Pregnancy Complications
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Healthy women with singleton pregnancies
- -
Who cannot join
- Twins pregnancies. Mothers with preexisting conditions. Malformations.
About this study
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.
- Conditions
- Pregnancy Complications
- Keywords
- pregnancy, physical activity, fetal growth
- Medical subject headings
- Pregnancy Complications, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal growth
Large for gestational age (LGA) small for gestational age (SGA)
Measured: birth weight at birth
Secondary outcomes (1)
Pregnancy complications
preeclampsia, diabetes, weight gain.
Measured: during pregnancy ( 9 months from start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Principal investigator, marija simic, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395652
- Sponsor's protocol ID
- Karolinskal
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2018
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Physical Activity and Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT03395652
- Acronym / sponsor ID
- Karolinskal
- Conditions
- Pregnancy Complications
- Keywords
- pregnancy, physical activity, fetal growth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: technical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Healthy women with singleton pregnancies
- -
Key exclusion criteria (1 listed)
- Twins pregnancies. Mothers with preexisting conditions. Malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal growth
Time frame: birth weight at birth
Large for gestational age (LGA) small for gestational age (SGA)
1 secondary outcome
Pregnancy complications
Time frame: during pregnancy ( 9 months from start)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal growth (time frame: birth weight at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.