NCT00873314

Bed Rest for Threatened Preterm Labor. Pilot Study

Bed Rest for Arrested Threatened Preterm Labor. Pilot Study for the Design of a Randomized Controlled Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Institute for Clinical Effectiveness and Health Policy · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bedrest
• Premature Labor

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2006-07-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2009-04-01
• Last updated: 2009-04-01

Locations

1 site across 1 country: Uruguay