Bed Rest for Threatened Preterm Labor. Pilot Study

Premature Labor Clinical Trial

Official title:

Bed Rest for Arrested Threatened Preterm Labor. Pilot Study for the Design of a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873314
• Other study ID #: CIHR01-2003
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: March 31, 2009
• Start date: July 2006
• Est. completion date: November 2006

Study information

• Verified date: March 2009
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Human Research Bioethics CommitteeArgentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bedrest
• Obstetric Labor, Premature
• Premature Labor

Intervention

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
• 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.

Locations

Country	Name	City	State
Uruguay	Pereira Rossell Hospital	Montevideo

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy	Unidad de Investigación Clínica y Epidemiológica Montevideo

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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