Preterm BirthNCT07698483
DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention
A study testing Multicomponent deimplementation strategy in people with Preterm Birth and Activity Restriction, run by University of Pennsylvania at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Activity Restriction, Bed Rest
- What is being tested?
- Multicomponent deimplementation strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kelli Jackson contact
United States2 sites, 2 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Beth L Pineles, MD, PhD, Beth.Pineles@Pennmedicine.upenn.edu
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Beth L Pineles, MD, PhD, Beth.Pineles@Pennmedicine.upenn.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth, Activity Restriction, Bed Rest, Low-Value Care
- Being tested
- Multicomponent deimplementation strategy
- Keywords
- deimplementation, low-value care, activity restriction, bedrest, preterm birth, audit and feedback, implementation science, hybrid trial
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent deimplementation strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Deimplementation strategy | Experimental | 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). Receives: Behavioral: Multicomponent deimplementation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-deimplementation period (approximately months 13 to 14)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start16 Jul 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for SMFM, American Association of Obstetricians and Gynecologists Foundation (AAOGF)
- Responsible party
- Principal investigator, Beth Pineles, University of Pennsylvania
- Investigators
- Beth L Pineles, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698483
- Sponsor's protocol ID
- 26-6387
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial
- ClinicalTrials.gov ID
- NCT07698483
- Acronym / sponsor ID
- 26-6387
- Conditions
- Preterm Birth, Activity Restriction, Bed Rest, Low-Value Care
- Keywords
- deimplementation, low-value care, activity restriction, bedrest, preterm birth, audit and feedback, implementation science, hybrid trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Foundation for SMFM, American Association of Obstetricians and Gynecologists Foundation (AAOGF)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deimplementation strategy | Experimental | Behavioral: Multicomponent deimplementation strategyAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent deimplementation strategyA 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. | Behavioural | Deimplementation strategy |
Primary outcome
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.
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.
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.
6 secondary outcomes
Penetration of activity restriction recommendations
Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Generalized anxiety (GAD-7)
Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Depressive symptoms (EPDS)
Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Perceived stress (PSS-10)
Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient and clinician relationship (PDRQ-9)
Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Quality of prenatal care (QPCQ)
Time frame: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
Active, not recruiting
Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
RecruitingObservational study
Cervical Stiffness in Women With Threatened Preterm Labor
Preterm Labor, Preterm Birth
Not yet recruiting
Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial
Preterm
Recruiting
Music Intervention for Preterm Birth
Preterm Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelli Jackson contact
Beth L Pineles, MD, PhD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent deimplementation strategy in people with Preterm Birth and Activity Restriction, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Pineles, MD, PhD (267-283-8210, Beth.Pineles@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Post-deimplementation period (approximately months 13 to 14)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.