Bed Rest for Threatened Preterm Labor. Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Clinical and Epidemiological Research Unit Montevideo
Information provided by:
Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier:
NCT00873314
First received: March 30, 2009
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

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 Intervention
Bedrest
Premature Labor
Behavioral: Bed rest
Behavioral: Activity restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Institute for Clinical Effectiveness and Health Policy:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873314

Locations
Uruguay
Pereira Rossell Hospital
Montevideo, Uruguay, 11500
Sponsors and Collaborators
Institute for Clinical Effectiveness and Health Policy
Clinical and Epidemiological Research Unit Montevideo
  More Information

Additional Information:
No publications provided

Responsible Party: Fernando Althabe, Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier: NCT00873314     History of Changes
Other Study ID Numbers: CIHR01-2003
Study First Received: March 30, 2009
Last Updated: March 31, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014