How doctors and nurses decide about bed rest in pregnancy
Official title: Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial
Run by University of Pennsylvania · NCT07698483 · Data updated 2026-11-12
This study tests a plan to stop routinely restricting activity or bed rest during pregnancy to see if providers accept it, find it appropriate, and change how often they recommend it for women at risk of preterm birth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 237 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Status | Recruiting |
| Started | July 16, 2026 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07698483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Providers and patients at high risk for preterm birth in participating Penn-affiliated sites who consent to participate and use the guideline and feedback system.
✕Probably not a fit
Patients unlikely to benefit include those for whom activity restriction is still clinically indicated due to specific conditions or complications.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
DE-RESTRICT is a pilot, single-arm study that introduces a local guideline aligned with national recommendations and provides education and feedback to prenatal care teams. The trial runs in four periods to develop, implement, and sustain the deimplementation strategy, tracking how often activity restriction is recommended and how acceptable and feasible the approach is for providers. Patient outcomes include experiences and reports from those at high risk for preterm birth, with exploratory data on preterm birth rates. All participating practices receive the strategy, and data are collected through provider surveys, an audit/feedback system, and patient-reported measures.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary bed rest and related harms while maintaining or improving pregnancy outcomes.
How similar studies have gone: Prior work suggests deimplementation of low-value care is feasible with guidelines and feedback, but this exact multicomponent strategy in preterm birth prevention is exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Beth L Pineles, MD, PhD — University of Pennsylvania
- Study coordinator: Beth Pineles, MD, PhD
- Email: Beth.Pineles@Pennmedicine.upenn.edu
- Phone: 267-283-8210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.