237 Participants NeededMy employer runs this trial

Deimplementing Activity Restriction for Preterm Birth

Recruiting at 1 trial location
BP
KJ
Overseen ByKelli Jackson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if reducing recommendations for bedrest and activity restriction during pregnancy is practical and well-received by healthcare providers. Although commonly suggested to prevent preterm birth, bedrest has not proven effective and may even cause harm. The trial uses a multicomponent deimplementation strategy, which includes educating healthcare providers and monitoring their recommendations to observe changes over time. Pregnant individuals at high risk for preterm birth, such as those with a history of early labor or specific pregnancy conditions, might be suitable for this study. As an unphased trial, it offers participants the opportunity to contribute to important research that could change pregnancy care practices.

What prior data suggests that this deimplementation strategy is safe for prenatal care?

In a previous study, researchers examined whether reducing activity restrictions and bedrest during pregnancy could prevent preterm birth. They found that these practices do not help and can even be harmful. The new strategy being tested aims to reduce unnecessary activity restrictions by better educating healthcare providers about current guidelines. This strategy involves training and giving feedback to doctors and nurses, with no specific safety concerns. This approach has not shown any negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the deimplementation strategy for preterm birth because it challenges the traditional approach of restricting activity to prevent preterm labor. Unlike the standard care that often involves bed rest and limiting physical activity, this strategy focuses on reducing unnecessary activity restrictions through a locally developed clinical guideline. The approach includes interactive educational sessions for healthcare providers and ongoing feedback, which helps align practices with national recommendations. This could lead to better outcomes by preventing the potential negative effects associated with excessive activity restrictions.

What evidence suggests that this deimplementation strategy is effective for reducing activity restriction recommendations in prenatal care?

Research has shown that limiting activity and staying in bed do not prevent early births and might even be harmful. National guidelines advise against these practices. In this trial, participating practices and providers will receive a multicomponent deimplementation strategy to reduce unnecessary medical practices, such as advising activity limitation. This strategy includes creating local guidelines, educating healthcare providers, and providing feedback on how often they recommend activity restriction. The goal is to align care with national recommendations, thereby improving patient outcomes and experiences.13678

Who Is on the Research Team?

BL

Beth L Pineles, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for prenatal care providers at two clinics within one health system. It does not enroll pregnant patients directly, but instead focuses on how providers recommend activity restriction or bedrest to prevent preterm birth.

Inclusion Criteria

I am pregnant or recently gave birth and have a high risk for preterm birth.
For Patients: Activity restriction recommendation measure collected through the Take Home Electronic Assessment (THEA) at 33 weeks of gestation, reaching only patients enrolled in THEA across all periods
I have a high-risk diagnosis that qualifies me for extra surveys.
See 1 more

Exclusion Criteria

I have chosen not to participate in deimplementation meetings or communications.
I am unable to walk or have not left the hospital since my diagnosis.

Timeline for a Trial Participant

Pre-deimplementation

Development of local clinical guideline and measurement of baseline outcomes

2 months
Multiple visits for guideline development and baseline measurement

Run-in

Delivery of most provider education through interactive sessions with feedback; audit and feedback begins

11 months
Regular educational sessions and feedback meetings

Maintenance

Continuation of audit and feedback

1 month
Ongoing audit and feedback sessions

Post-deimplementation

Continuation of audit and feedback; measurement of outcomes

2 months
Final outcome measurement visits

Follow-up

Participants are monitored for safety and effectiveness after the main trial phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Multicomponent deimplementation strategy

Trial Overview

The study tests a strategy to reduce unnecessary recommendations of bedrest and activity restriction during pregnancy by educating providers, giving feedback, and creating local guidelines. The goal is to see if this approach changes provider behavior.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Deimplementation strategyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

American Association of Obstetricians and Gynecologists Foundation (AAOGF)

Collaborator

Foundation for SMFM

Collaborator

Citations

DE-RESTRICT: Deimplementing Activity... | Clinical Trial

This pilot single-arm hybrid effectiveness-deimplementation trial evaluates a multicomponent strategy to deimplement activity restriction and ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39813049/

Multicomponent Deimplementation Strategy to Reduce Low ...

Results: A total of 1143 patients (mean [SD] age, 58.7 [15.5] years; 643 female [56.3%]) underwent 261 operations (23%) in the preintervention ...

Public Health Strategies to Prevent Preterm Birth | MMWR

Reducing preterm births can be accomplished by targeting risk factors and populations at highest risk and by improving quality of care.

Multicomponent Deimplementation Strategy to Reduce ...

Results A total of 1143 patients (mean [SD] age, 58.7 [15.5] years; 643 female [56.3%]) underwent 261 operations (23%) in the preintervention ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35034072/

Activity restriction and preterm birth prevention

AR does not improve obstetrical and perinatal outcomes but does confer significant physical and psychological risks.

Interventions to reduce preterm birth and stillbirth ... - PMC - NIH

Reducing preterm birth and stillbirth and improving outcomes for babies born too soon is essential to reduce under-5 mortality globally.

Preterm birth

WHO fact sheet on preterm birth providing key facts and information on solution, geographical distribution and WHO response.

Preterm Birth: Causes, Consequences, and Prevention ...

Compared with infants born at term (37 to 41 weeks of gestation), preterm infants have a much greater risk of death and disability. Approximately 75 percent of ...