Bed Rest for Threatened Preterm Labor. Pilot Study
Primary Purpose
Bedrest, Premature Labor
Status
Completed
Phase
Not Applicable
Locations
Uruguay
Study Type
Interventional
Intervention
Bed rest
Activity restriction
Sponsored by
About this trial
This is an interventional prevention trial for Bedrest
Eligibility Criteria
Inclusion Criteria:
- Every woman admitted to hospital during the antenatal period because of an episode of TPL. If the attending physician decides that the woman is ready for hospital discharge the woman will be eligible for the study.
Exclusion criteria:
- Multiple pregnancy
- Premature rupture of membranes
- Cervical cerclage and whenever the attendant physician considers that the woman is not eligible to be randomized to bed rest or activity restriction.
Sites / Locations
- Pereira Rossell Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bed rest
Activity restriction
Arm Description
Outcomes
Primary Outcome Measures
The outcome was the amount of activity. In order to measure the outcome, we used: a) an accelerometer which was delivered to the woman at home and b) a diary record that the woman fulfilled during the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00873314
First Posted
March 30, 2009
Last Updated
March 31, 2009
Sponsor
Institute for Clinical Effectiveness and Health Policy
Collaborators
Unidad de Investigación Clínica y Epidemiológica Montevideo
1. Study Identification
Unique Protocol Identification Number
NCT00873314
Brief Title
Bed Rest for Threatened Preterm Labor. Pilot Study
Official Title
Bed Rest for Arrested Threatened Preterm Labor. Pilot Study for the Design of a Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute for Clinical Effectiveness and Health Policy
Collaborators
Unidad de Investigación Clínica y Epidemiológica Montevideo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the pilot trial is to assess at what extend women with arrested threatened preterm labor change their activity patterns at home in response to bed rest prescription.
An area of concern for the design of a trial is the strength of health provider's recommendation to change women's behaviors, and their compliance with bed rest recommendations. The study was a randomized parallel design. The intervention group consisted of total bed rest for four days (with allowance to go to the toilet). The control group consisted in the restriction of activities during four days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bedrest, Premature Labor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bed rest
Arm Type
Experimental
Arm Title
Activity restriction
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Bed rest
Intervention Description
The woman assigned to the bed rest group, will be instructed to keep in bed for the study period of four days and will be allowed to go to the toilet
Intervention Type
Behavioral
Intervention Name(s)
Activity restriction
Intervention Description
Women assigned to activity restriction group will do the restriction of activities during four days.During the activity restriction phase the women will be allowed to ambulate at home, work at home (home office), child care, household tasks, meal preparation or any forceless activities.
Primary Outcome Measure Information:
Title
The outcome was the amount of activity. In order to measure the outcome, we used: a) an accelerometer which was delivered to the woman at home and b) a diary record that the woman fulfilled during the study.
Time Frame
Four days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Every woman admitted to hospital during the antenatal period because of an episode of TPL. If the attending physician decides that the woman is ready for hospital discharge the woman will be eligible for the study.
Exclusion criteria:
Multiple pregnancy
Premature rupture of membranes
Cervical cerclage and whenever the attendant physician considers that the woman is not eligible to be randomized to bed rest or activity restriction.
Facility Information:
Facility Name
Pereira Rossell Hospital
City
Montevideo
ZIP/Postal Code
11500
Country
Uruguay
12. IPD Sharing Statement
Links:
URL
http://www.iecs.org.ar/
Description
Institute for Clinical Effectiveness and Health Policy
URL
http://www.fmed.edu.uy/
Description
School of Medicine of the University of the Republic
URL
http://www.unicem-web.org/
Description
Clinical and Epidemiological Research Unit Montevideo
Learn more about this trial
Bed Rest for Threatened Preterm Labor. Pilot Study
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