DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

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.

Conditions

• Preterm Birth
• Activity Restriction
• Bed Rest
• Low-Value Care

Interventions

BEHAVIORAL

Multicomponent deimplementation strategy

A multicomponent strategy to reduce provider-recommended activity restriction and bedrest for preterm birth prevention, comprising development of a local clinical guideline aligned with national recommendations and identification of site champions; interactive educational sessions for providers with feedback; periodic audit and feedback to practices on the rate of activity restriction recommendations; and patient educational materials on safe physical activity in pregnancy that are made available to clinicians, who may choose to share them with patients. Delivered across the run-in, maintenance, and post-deimplementation periods and linked to the single study arm.

Sponsors & Collaborators

• Foundation for SMFM

  collaborator UNKNOWN

• American Association of Obstetricians and Gynecologists Foundation (AAOGF)

  collaborator UNKNOWN

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Beth L Pineles, MD, PhD · University of Pennsylvania

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-16

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United States

Study Locations