Maternal HealthNCT07108335
Provider and Patient RCT PROMOTE
A study testing PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) in people with Maternal Health and Pregnancy, run by Duke University.
Trial summary
Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. Investigators will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- 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
- 404 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Aug 2029
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patients who are 24 - 32 weeks gestation
- Employed or unemployed and seeking paid employment
- Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)
Who cannot join
- Non- English language fluency
- Unemployed with no desire to seek paid employment
- Not a clinical team member
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kristin Weaver contact
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. Investigators 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.
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 Patient Education | Experimental | This arm is provided with Patient Education from providers that have received training on PROMOTE. Receives: Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE) |
| Usual Care | No intervention | This arm has patients who receive care of a provider that was not trained on the PROMOTE curriculum. |
| 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 of Provider | 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: From enrollment to 12 weeks after birth of child
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: From enrollment to 12 weeks after birth of child
Number of participants with undesired wage or advancement reduction
Determined by responses to surveys and qualitative interviews about work experiences.
Measured: From enrollment to 12 weeks after birth of baby
Number of participants with accommodation requests granted
Determined by responses to surveys and qualitative interviews about work experiences.
Measured: From enrollment to 12 weeks after birth of baby
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: From enrollment to 12 weeks after birth of baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Oct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
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
- 404 participants (estimated)
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
- NCT07108335
- Sponsor's protocol ID
- Pro00116081
- Other IDs
- 1R01HD115609-01
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2025
- Last updated
- 20 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 20 Aug 2026. 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
- NCT07108335
- Acronym / sponsor ID
- Pro00116081
- Conditions
- Maternal Health, Pregnancy, Employment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 7 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. Investigators 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Receiving Patient Education | Experimental | Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)This arm is provided with Patient Education from providers that have received training on PROMOTE. |
| Usual Care | No intervention | –This arm has patients who receive care of a provider that was not trained on the PROMOTE curriculum. |
| Receiving Provider PROMOTE Training | Experimental | Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)Providers in this arm will receive training on PROMOTE |
| Usual Care of Provider | No intervention | –Providers in this arm will continue usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant patients who are 24 - 32 weeks gestation
- Employed or unemployed and seeking paid employment
- Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)
Key exclusion criteria (3 listed)
- Non- English language fluency
- Unemployed with no desire to seek paid employment
- 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 Patient Education |
| 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: From enrollment to 12 weeks after birth of child
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: From enrollment to 12 weeks after birth of child
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: From enrollment to 12 weeks after birth of baby
Determined by responses to surveys and qualitative interviews about work experiences.
Number of participants with accommodation requests granted
Time frame: From enrollment to 12 weeks after birth of baby
Determined by responses to surveys and qualitative interviews about work experiences.
Number of participants with improved maternal-infant health in pregnancy
Time frame: From enrollment to 12 weeks after birth of baby
Determined by EHR-documented maternal infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.
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 20 Aug 2026.
- 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.
Kristin Weaver contact
Sarahn Wheeler, MD principal investigator
Duke University
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.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sarahn Wheeler, MD (919-681-5220, sarahn.wheeler@duke.edu), or a site near the patient. 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: From enrollment to 12 weeks after birth of child). 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 20 Aug 2026.