DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preterm Birth; Bed Rest; Low-Value Care; Activity Restriction
• Intervention / Treatment: Behavioral: Multicomponent deimplementation strategy

Detailed Description

This pilot single-arm hybrid effectiveness-deimplementation trial evaluates a multicomponent strategy to deimplement activity restriction and bedrest prescribed for preterm birth prevention among prenatal care providers and patients at high risk for preterm birth. All participating practices receive the strategy; there is no control arm. The strategy comprises a locally developed clinical guideline aligning with national recommendations, interactive provider education with feedback, and audit and feedback on the rate of activity restriction recommendations.

The four periods are sequential. The guideline is developed during the pre-deimplementation period, when baseline outcomes are also measured. Most provider education is delivered during the run-in period through interactive educational sessions with feedback, and audit and feedback begins. Audit and feedback continues through the maintenance and post-deimplementation periods. Outcomes are measured in the pre-deimplementation and post-deimplementation periods, and the rate of activity restriction recommendations is tracked continuously through an existing clinical text-messaging platform to support audit and feedback.

Primary outcomes are provider-reported acceptability, appropriateness, and feasibility. Secondary outcomes are the penetration of activity restriction recommendations and patient-reported outcomes. The preterm birth rate is an exploratory outcome. Analyses compare the pre-deimplementation and post-deimplementation periods, with nonresponse weighting and adjustment for patient age, race, parity, and qualifying diagnosis, and a hospital by period interaction for hospital-level estimates.

• Study Type: Interventional
• Enrollment (Estimated): 237
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Pineles, MD, PhD; Phone Number: 267-283-8210; Email: Beth.Pineles@Pennmedicine.upenn.edu
• Study Contact Backup: Name: Kelli Jackson; Email: Kelli.Jackson@PennMedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
      • Contact: Beth L Pineles, MD, PhD; Email: Beth.Pineles@Pennmedicine.upenn.edu
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
      • Contact: Beth L Pineles, MD, PhD; Email: Beth.Pineles@Pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration of activity restriction recommendations	Proportion of patients enrolled in THEA who, at 33 weeks, report a provider recommendation for activity restriction or bedrest, measured through the clinical text-messaging platform.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Generalized anxiety (GAD-7)	Patient score on the GAD-7.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Depressive symptoms (EPDS)	Patient score on the Edinburgh Postnatal Depression Scale.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Perceived stress (PSS-10)	Patient score on the Perceived Stress Scale.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient and clinician relationship (PDRQ-9)	Patient score on the Patient Doctor Relationship Questionnaire.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Quality of prenatal care (QPCQ)	Patient score on the Quality of Prenatal Care Questionnaire across its six subscales.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth rate	Deliveries before 37 weeks divided by total deliveries at the included hospitals; no participant identifiers collected.	Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: American Association of Obstetricians and Gynecologists Foundation (AAOGF); Foundation for SMFM
• Investigators: Principal Investigator: Beth L Pineles, MD, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: preterm birth; bedrest; implementation science; activity restriction; audit and feedback; low-value care; hybrid trial; deimplementation
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 26-6387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No