Maternal HealthNCT07126405
Provider RCT PROMOTE
A study testing PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) in people with Maternal Health and Pregnancy, run by Duke University at 1 site in United States.
Trial summary
Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. We will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Pregnancy, Employment
- What is being tested?
- PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)
Who cannot join
- Not a clinical team member
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. We will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. The investigators will compare the frequency of EHR documented work- related counseling and adherence to employer documentation recommendations between the two study arms.
Hypothesis: Patients receiving care by a provider randomized to PROMOTE will have higher rates of documented counseling about work and pregnancy.
Read more
Research Aim 2: Determine the effectiveness of PROMOTE vs. usual care to reduce undesired wage or advancement reduction, increase accommodation requests granted, and improve maternal-infant health. The investigators will recruit a racially and socioeconomically diverse cohort of 304 pregnant patients and compare responses to surveys and qualitative interviews about work experiences and EHR-documented maternal-infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.
Hypothesis: Compared to patients receiving care by providers randomized to usual care, participants receiving care by providers randomized to PROMOTE will have less undesired loss of wages and advancement, increased accommodation request granted, and improved maternal-infant health during pregnancy.
- Conditions
- Maternal Health, Pregnancy, Employment
- Being tested
- PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)Other
An on-demand 30-minute web-based training for clinical team members that provides a high-level summary of federal employment laws, work note templates embedded into the electronic health record (EHR) that prompt the clinician team member to include relevant information, and a patient-facing infographic designed to facilitate clinician counseling.
| Study group | Role | What they receive |
|---|---|---|
| Receiving Provider PROMOTE Training | Experimental | Providers in this arm will receive training on PROMOTE Receives: Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) |
| Usual Care | No intervention | Providers in this arm will continue usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of EHR (electronic health record) documented work-related counseling
Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.
Measured: Up to 1 year
Number of participants who adhere to employer documentation recommendations
Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.
Measured: Up to 1 year
Number of participants with undesired wage or advancement reduction
Determined by responses to surveys and qualitative interviews about work experiences.
Measured: Up to 1 year
Number of participants with accommodation requests granted
Determined by responses to surveys and qualitative interviews about work experiences.
Measured: Up to 1 year
Number of participants with improved maternal-infant health in pregnancy
Determined by EHR-documented maternal infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: Study has been combined with the patient portion of this study under Pro00116081
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sarahn Wheeler, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126405
- Sponsor's protocol ID
- Pro00118409
- Other IDs
- 1R01HD115609-01
- Status last verified
- Oct 2025
- First submitted
- 5 Aug 2025
- Last updated
- 27 Oct 2025
- 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 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)
- ClinicalTrials.gov ID
- NCT07126405
- Acronym / sponsor ID
- Pro00118409
- Conditions
- Maternal Health, Pregnancy, Employment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been combined with the patient portion of this study under Pro00116081
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Aug 2025 (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.
Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. We will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. The investigators will compare the frequency of EHR documented work- related counseling and adherence to employer documentation recommendations between the two study arms.
Hypothesis: Patients receiving care by a provider randomized to PROMOTE will have higher rates of documented counseling about work and pregnancy.
Research Aim 2: Determine the effectiveness of PROMOTE vs. usual care to reduce undesired wage or advancement reduction, increase accommodation requests granted, and improve maternal-infant health. The investigators will recruit a racially and socioeconomically diverse cohort of 304 pregnant patients and compare responses to surveys and qualitative interviews about work experiences and EHR-documented maternal-infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.
Hypothesis: Compared to patients receiving care by providers randomized to usual care, participants receiving care by providers randomized to PROMOTE will have less undesired loss of wages and advancement, increased accommodation request granted, and improved maternal-infant health during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving Provider PROMOTE Training | Experimental | Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)Providers in this arm will receive training on PROMOTE |
| Usual Care | No intervention | –Providers in this arm will continue usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)
Key exclusion criteria (1 listed)
- Not a clinical team member
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 |
|---|---|---|
| PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)An on-demand 30-minute web-based training for clinical team members that provides a high-level summary of federal employment laws, work note templates embedded into the electronic health record (EHR) that prompt the clinician team member to include relevant information, and a patient-facing infographic designed to facilitate clinician counseling. | Other | Receiving Provider PROMOTE Training |
Primary outcome
Frequency of EHR (electronic health record) documented work-related counseling
Time frame: Up to 1 year
Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.
Number of participants who adhere to employer documentation recommendations
Time frame: Up to 1 year
Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy.
Number of participants with undesired wage or advancement reduction
Time frame: Up to 1 year
Determined by responses to surveys and qualitative interviews about work experiences.
Number of participants with accommodation requests granted
Time frame: Up to 1 year
Determined by responses to surveys and qualitative interviews about work experiences.
Number of participants with improved maternal-infant health in pregnancy
Time frame: Up to 1 year
Determined by EHR-documented maternal infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sarahn Wheeler, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) in people with Maternal Health and Pregnancy, run by Duke University at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of EHR (electronic health record) documented work-related counseling (time frame: Up to 1 year). The study lists 5 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 27 Oct 2025.