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DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

University of Pennsylvania · with Foundation for SMFM, American Association of Obstetricians and Gynecologists Foundation (AAOGF) · NCT07698483

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
237
US sites recruiting
2
Study start
July 16, 2026
Record last updated
August 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Multicomponent deimplementation strategy

Conditions: Preterm Birth; Activity Restriction; Bed Rest; Low-Value Care

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Beth L Pineles, MD, PhD · Beth.Pineles@Pennmedicine.upenn.edu

  • Pennsylvania Hospital

    Philadelphia, PA 19107

    Site contact: Beth L Pineles, MD, PhD · Beth.Pineles@Pennmedicine.upenn.edu

Study contacts (from the official record)

  • Beth Pineles, MD, PhD · 267-283-8210 · Beth.Pineles@Pennmedicine.upenn.edu
  • Kelli Jackson · Kelli.Jackson@PennMedicine.upenn.edu
All pregnancy studies in Pennsylvania →
DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth… (NCT07698483) | Bored Studies