Recruiting

Activity Restriction

Sponsor:

University of Pennsylvania

Code:

NCT07698483

Conditions

Preterm Birth

Activity Restriction

Bed Rest

Low-Value Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Multicomponent deimplementation strategy

Study Details

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

Study ID

NCT07698483

Start date

Jul 16, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

237 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Deimplementation strategy

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).

Interventions

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.

Primary outcome measure

  • Acceptability of Intervention Measure (AIM) [ Time Frame: Post-deimplementation period (approximately months 13 to 14) ]
  • Intervention Appropriateness Measure (IAM) [ Time Frame: Post-deimplementation period (approximately months 13 to 14) ]
  • Feasibility of Intervention Measure (FIM) [ Time Frame: Post-deimplementation period (approximately months 13 to 14) ]

Central Contacts and Locations

Central contacts

Beth Pineles, MD, PhD

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

Kelli Jackson

Kelli.Jackson@PennMedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Beth L Pineles, MD, PhD

Beth.Pineles@Pennmedicine.upenn.edu

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Beth L Pineles, MD, PhD

Beth.Pineles@Pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-10.