Back to resultsPhysical Activity and Preterm Birth With Cervical Dynamics
Primary Purpose
Preterm Birth
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
activity
Sponsored by
About this trial
This is an interventional other trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
pregnant women between 24-34 weeks of gestation singleton cervical length<25 mm willing to download an application which traces physical activity on medical indication for reducing activity
Exclusion Criteria:
refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy
-
Sites / Locations
- edith wolfsom MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
activity
bed rest
Arm Description
Outcomes
Primary Outcome Measures
preterm birth
birth prior to 37 weeks of gestation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04409678
Brief Title
Physical Activity and Preterm Birth With Cervical Dynamics
Official Title
Influence of Physical Activity on Preterm Birth for Women With Cervical Dynamics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
May 26, 2021 (Anticipated)
Study Completion Date
May 26, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
activity
Arm Type
Experimental
Arm Title
bed rest
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
activity
Intervention Description
physical activity
Primary Outcome Measure Information:
Title
preterm birth
Description
birth prior to 37 weeks of gestation
Time Frame
assessed from recruitment to delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women between 24-34 weeks of gestation singleton cervical length<25 mm willing to download an application which traces physical activity on medical indication for reducing activity
Exclusion Criteria:
refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yakira Izaik, Doctor
Phone
972545533462
Email
yakyuk@gmail.com
Facility Information:
Facility Name
edith wolfsom MC
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yakira izaik, doctor
Phone
972545533462
Email
yakyuk@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Physical Activity and Preterm Birth With Cervical Dynamics
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