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Bed Rest for Threatened Preterm Labor. Pilot Study

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ClinicalTrials.gov Identifier: NCT00873314
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : April 1, 2009
Sponsor:
Collaborator:
Unidad de Investigación Clínica y Epidemiológica Montevideo
Information provided by:
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.


Condition or disease Intervention/treatment
Bedrest Premature Labor Behavioral: Bed rest Behavioral: Activity restriction

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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.
Study Start Date : July 2006
Primary Completion Date : November 2006
Study Completion Date : November 2006

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.



Primary Outcome Measures :
  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. [ Time Frame: Four days ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873314


Locations
Uruguay
Pereira Rossell Hospital
Montevideo, Uruguay, 11500
Sponsors and Collaborators
Institute for Clinical Effectiveness and Health Policy
Unidad de Investigación Clínica y Epidemiológica Montevideo

Additional Information:
Responsible Party: Fernando Althabe, Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier: NCT00873314     History of Changes
Other Study ID Numbers: CIHR01-2003
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications