Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

5 augusti 2026 uppdaterad av: Beth Pineles, University of Pennsylvania

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

237

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptability of Intervention Measure (AIM)
Tidsram: 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.
Post-deimplementation period (approximately months 13 to 14)
Intervention Appropriateness Measure (IAM)
Tidsram: 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.
Post-deimplementation period (approximately months 13 to 14)
Feasibility of Intervention Measure (FIM)
Tidsram: 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.
Post-deimplementation period (approximately months 13 to 14)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Penetration of activity restriction recommendations
Tidsram: 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.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Generalized anxiety (GAD-7)
Tidsram: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient score on the GAD-7.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Depressive symptoms (EPDS)
Tidsram: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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)
Tidsram: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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)
Tidsram: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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)
Tidsram: 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.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Preterm birth rate
Tidsram: 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.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Pennsylvania

Samarbetspartners

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

Utredare

  • Huvudutredare: Beth L Pineles, MD, PhD, University of Pennsylvania

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juli 2026

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

31 augusti 2027

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

13 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 augusti 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 26-6387

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera