Bed Rest for Threatened Preterm Labor. Pilot Study
This study has been completed.
Sponsor:
Institute for Clinical Effectiveness and Health Policy
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
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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 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 June 17, 2013