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NCT Number: NCT07698483

DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

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.

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Key information

Conditions

Preterm Birth Activity Restriction Bed Rest Female Urogenital Diseases and Pregnancy Complications Low-Value Care Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multicomponent deimplementation strategy

Behavioral

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 outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: 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.

  2. Intervention Appropriateness Measure (IAM)

    Time frame: 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.

  3. Feasibility of Intervention Measure (FIM)

    Time frame: 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.

Secondary outcomes

  1. Penetration of activity restriction recommendations

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    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.

  2. Generalized anxiety (GAD-7)

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    Patient score on the GAD-7.

  3. Depressive symptoms (EPDS)

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    Patient score on the Edinburgh Postnatal Depression Scale.

  4. Perceived stress (PSS-10)

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    Patient score on the Perceived Stress Scale.

  5. Patient and clinician relationship (PDRQ-9)

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    Patient score on the Patient Doctor Relationship Questionnaire.

  6. Quality of prenatal care (QPCQ)

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    Patient score on the Quality of Prenatal Care Questionnaire across its six subscales.

Other outcomes

  1. Preterm birth rate

    Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

    Deliveries before 37 weeks divided by total deliveries at the included hospitals; no participant identifiers collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Pineles, MD, PhD

CONTACT

[email protected]

267-283-8210

Kelli Jackson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • American Association of Obstetricians and Gynecologists Foundation (AAOGF)
  • Foundation for SMFM

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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