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.

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.

Study Overview

• Status: Completed
• Conditions: Premature Labor; Bedrest
• Intervention / Treatment: Behavioral: Bed rest; Behavioral: Activity restriction

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uruguay
  • Montevideo, Uruguay, 11500
    • Pereira Rossell Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute for Clinical Effectiveness and Health Policy
• Collaborators: Unidad de Investigación Clínica y Epidemiológica Montevideo

Publications and helpful links

Helpful Links

• School of Medicine of the University of the Republic
• Clinical and Epidemiological Research Unit Montevideo
• Institute for Clinical Effectiveness and Health Policy

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Estimate): April 1, 2009
• Last Update Submitted That Met QC Criteria: March 31, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: CIHR01-2003