DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

NCT07698483 | Not Yet Recruiting

• 1 other identifier: 26-6387
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

deimplementation; low-value care; activity restriction; bedrest; preterm birth; audit and feedback; implementation science; hybrid trial

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  Mean provider score on the 4-item AIM, 5-point scale; higher scores indicate greater acceptability of the deimplementation strategy.

  Post-deimplementation period (approximately months 13 to 14)

• Intervention Appropriateness Measure (IAM)

  Mean provider score on the 4-item IAM, 5-point scale; higher scores indicate greater perceived appropriateness.

  Post-deimplementation period (approximately months 13 to 14)

• Feasibility of Intervention Measure (FIM)

  Mean provider score on the 4-item FIM, 5-point scale; higher scores indicate greater perceived feasibility.

  Post-deimplementation period (approximately months 13 to 14)

Secondary Outcomes (6)

• Penetration of activity restriction recommendations

  Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

• Generalized anxiety (GAD-7)

  Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

• Depressive symptoms (EPDS)

  Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

• Perceived stress (PSS-10)

  Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

• Patient and clinician relationship (PDRQ-9)

  Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

Other Outcomes (1)

• Preterm birth rate

  Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

Study Arms (1)

Deimplementation strategy

EXPERIMENTAL

All participating practices and providers receive the multicomponent deimplementation strategy. There is a single group and no control arm. The strategy comprises a locally developed clinical guideline aligning with national recommendations (developed in the pre-deimplementation period), interactive educational sessions with feedback delivered to providers (most delivered in the run-in period), and audit and feedback on the rate of activity restriction recommendations (delivered continuously from the run-in period through the post-deimplementation period).

Behavioral: Multicomponent deimplementation strategy

Interventions

Multicomponent deimplementation strategy BEHAVIORAL

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.

Deimplementation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Providers: Physicians, midwives, physician assistants, nurse practitioners, nurses, nursing assistants, medical assistants, and other healthcare staff who provide or participate in prenatal or high-risk pregnancy care or consultation at a participating site.
• For Patients: Secondary patient-reported outcomes draw on pregnant individuals at high risk for preterm birth (qualifying diagnoses include short cervix, cervical insufficiency, multiple gestation, preterm labor, preterm contractions, vaginal bleeding, placental conditions, or a history of prior preterm birth), between 0 and 12 weeks postpartum for the survey measures. The activity restriction recommendation measure is collected through the Take Home Electronic Assessment (THEA) and therefore reaches only patients enrolled in THEA, at 33 weeks of gestation, across all periods; in the pre-deimplementation and post-deimplementation periods the additional survey battery is sent only to patients with a qualifying high-risk diagnosis.

You may not qualify if:

• For Providers: Staff who self-exclude by choosing not to interact with deimplementation meetings and communications
• For Patients: Patients are excluded if they are unable to walk or are hospitalized without discharge home before delivery after the qualifying diagnosis is made.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Foundation for SMFM: collaborator
• American Association of Obstetricians and Gynecologists Foundation (AAOGF): collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Beth L Pineles, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Pineles, MD, PhD

CONTACT

267-283-8210; Beth.Pineles@Pennmedicine.upenn.edu

Kelli Jackson

CONTACT

Kelli.Jackson@PennMedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics & Gynecology and Epidemiology

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)