Bed Rest for Threatened Preterm Labor. Pilot Study

Institute for Clinical Effectiveness and Health Policy

Status: Completed

Conditions: Bedrest; Premature Labor

Treatments: Behavioral: Activity restriction; Behavioral: Bed rest

Study type: Interventional

Funder types: Other

Identifiers

NCT00873314

CIHR01-2003

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups, including a placebo group

Bed rest

Experimental group

Treatment:

Behavioral: Bed rest

Activity restriction

Placebo Comparator group

Treatment:

Behavioral: Activity restriction