Bed Rest for Threatened Preterm Labor. Pilot Study
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.
|Bedrest Premature Labor||Behavioral: Bed rest Behavioral: Activity restriction|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Bed Rest for Arrested Threatened Preterm Labor. Pilot Study for the Design of a Randomized Controlled Clinical Trial.|
- 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 ]
|Study Start Date:||July 2006|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
|Experimental: Bed rest||
Behavioral: Bed rest
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
|Placebo Comparator: Activity restriction||
Behavioral: Activity restriction
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873314
|Pereira Rossell Hospital|
|Montevideo, Uruguay, 11500|