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DE-RESTRICT: Reducing Activity Restriction for Preterm Birth Prevention

This study, called DE-RESTRICT, is testing a new approach to help doctors and other healthcare providers reduce recommendations for activity restriction and bed rest during pregnancy. These recommendations are often given to prevent preterm birth (when a baby is born too early), but national guidelines suggest they don't work and might even cause harm. The study is evaluating a "multicomponent deimplementation strategy" which includes new guidelines and educational sessions for providers. Researchers want to see if this strategy is acceptable, appropriate, and feasible for providers, and if it changes how often they recommend activity restriction. The study aims to enroll 237 participants, who are healthcare providers. The current status of the study is unclear.

Study design
This is a single-arm study, meaning all participating healthcare practices will receive the new strategy; there is no comparison group. The study will involve approximately 237 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be measured in the post-deimplementation period, which is approximately 13 to 14 months after the strategy is introduced.

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NCT07698483

DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

Not Yet Recruiting
NAAges 18+InterventionalHealth services
University of Pennsylvania
~237 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Multicomponent deimplementation strategy

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of Intervention Measure (AIM)
Measured over Post-deimplementation period (approximately months 13 to 14)
+2 more outcomes measured

Conditions

Preterm Birth
Activity Restriction
Bed Rest
Low-Value Care

Explore related trials

Preterm Birth

Where it's being run

2 sites across 1 states
Pennsylvania2

Study leadership

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

Who to contact

Beth Pineles, MD, PhD
[email protected]
267-283-8210
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Acceptability of Intervention Measure (AIM)Post-deimplementation period (approximately months 13 to 14)

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

  • Intervention Appropriateness Measure (IAM)Post-deimplementation period (approximately months 13 to 14)

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

  • Feasibility of Intervention Measure (FIM)Post-deimplementation period (approximately months 13 to 14)

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