Bed Rest for Threatened Preterm Labor. Pilot Study

Not Applicable

Completed

• Conditions: Bedrest; Premature Labor

• Registration Number: NCT00873314
• Lead Sponsor: Institute for Clinical Effectiveness and Health Policy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-31
• Last Update Submitted: 2009-03-31
• Study First Posted: 2009-04-01
• Last Update Posted: 2009-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Four days

Trial Locations

Locations (1)

Pereira Rossell Hospital; 🇺🇾 Montevideo, Uruguay