Clinical Trial

DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

Recruiting
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Summary
DE-RESTRICT is a pilot study testing whether a strategy to reduce the use of activity restriction and bedrest in pregnancy is acceptable, appropriate, and feasible for prenatal care providers, and whether it changes how often activity restriction is recommended. Activity restriction and bedrest are commonly advised to try to prevent preterm birth, but they do not prevent it and may cause harm, and national guidelines recommend against them. The study takes place at two prenatal care settings within one health system and unfolds across four periods. In the pre-deimplementation period the study team develops a local clinical guideline and measures baseline outcomes. In the run-in period most provider education is delivered through interactive sessions with feedback, and audit and feedback begins. In the maintenance period audit and feedback continues. In the post-deimplementation period audit and feedback continues and outcomes are measured again. The study measures provider acceptability, appropriateness, and feasibility, the rate of activity restriction recommendations, patient-reported wellbeing and care experience, and the preterm birth rate.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-11
Trial Details
NCT Number NCT07698483
Lead Sponsor University of Pennsylvania
Collaborators: Foundation for SMFM, American Association of Obstetricians and Gynecologists Foundation (AAOGF)
Conditions Preterm Birth, Activity Restriction, Bed Rest, Low-Value Care
Enrollment 237 participants
Start Date 2026-07-16
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10