Maternal Physical Activity and Pregnancy Outcome | NCT03395652

Studies
Maternal Physical Activity and Pregnancy Outcome

NCT03395652

Sponsor

Karolinska Institutet

Status

Withdrawn

Last Update Posted

Nov 25, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pregnancy Complications

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

technical problems

Expanded Access Info

Start Date

Jan 2018Estimated

Primary Completion Date

Jan 2019Estimated

Completion Date

May 2019Estimated

First Submitted Date

Jan 4, 2018

First Submission Date that Met QC Criteria

Jan 4, 2018

First Posted Date

Jan 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2020

Last Update Posted Date

Nov 25, 2020Actual

Name	Class
University of Belgrade	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fetal growth	Large for gestational age (LGA) small for gestational age (SGA)	birth weight at birth

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy complications	preeclampsia, diabetes, weight gain.	during pregnancy ( 9 months from start)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy women with singleton pregnancies

Exclusion Criteria:

Twins pregnancies. Mothers with preexisting conditions. Malformations.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications
D009043	Motor Activity

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided