Bed Rest for Threatened Preterm Labor. Pilot Study

NCT00873314 | Completed

• 1 other identifier: CIHR01-2003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Bedrest; Premature Labor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bed rest

EXPERIMENTAL

Behavioral: Bed rest

Activity restriction

PLACEBO COMPARATOR

Behavioral: Activity restriction

Interventions

Bed rest BEHAVIORAL

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

Bed rest

Activity restriction BEHAVIORAL

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.

Activity restriction

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Pereira Rossell Hospital

Montevideo, 11500, Uruguay

Location

Related Links

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

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Bed Rest

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 1, 2009
• Study Start: July 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: April 1, 2009

Record last verified: 2009-03

Locations

UR (1)