Pregnancy RelatedBUNDLENCT05993689
Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
A study testing BUNDLE in people with Pregnancy Related, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community healthcare… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- BUNDLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 30 Jun 2030
- 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
- Self-reported Black or African American
- Pregnant with singleton gestation
- Has an established OBGY at Froedtert \& the Medical College of Wisconsin (F\&MCW) Health System
Who cannot join
- Planning to deliver outside of F\&MCW Health System
- Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
Erica Marion, PhD, 4148058505, emarion@mcw.edu
Alyssa Hernandez, DO, 4148055285, alyhernandez@mcw.edu
About this study
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.
Read the detailed description
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The investigators will pursue the following aims using a multidisciplinary team of experts in health disparities, community engagement, qualitative research, maternal-fetal medicine, and doula support:
Aim 1: Develop an integrated prenatal care model of medical providers and community doulas in Southeastern Wisconsin Approach: The investigators will conduct six focus groups with 30 Black/AA birthing people (currently pregnant or recently postpartum) and 30 prenatal healthcare providers (obstetricians, midwives, doulas, social workers, prenatal care coordinators, nurses, mental health providers, and obstetric unit leaders) to elicit feedback on models of doula/medical provider integration with the overarching aim of building trust and improving maternal health outcomes. Focus group findings will be reviewed with a community advisory panel (CAP) developed as part of the Community Partnership of the MCW U54 center, to gain the CAP's input on intervention development.
Aim 2: Compare the effectiveness of the integrated prenatal care model to standard prenatal care in improving healthcare engagement and trust and reducing adverse maternal outcomes Approach: In a two-arm randomized controlled trial conducted at Froedtert and MCW, the investigators will randomize 412 Black/AA pregnant people to BUNDLE or standard prenatal care. Primary outcome is healthcare engagement (starting prenatal care in 1st trimester, attending at least 70% of the recommended visits, attending the postpartum visit, and receipt of recommended vaccination during pregnancy). Secondary outcomes include medical mistrust measured by trust in provider scale, perceived discrimination, and frequencies of severe maternal morbidity as defined by the Centers for Disease Control.
Aim 3: Disseminate findings to scholarly and community-based forums and actively pursue opportunities for systems- and policy-level change Approach: The investigators will disseminate findings regularly in scholarly (conference, grand rounds) and community-based (listening session, town hall) forums. The investigators will leverage the existing partnerships with policymakers, healthcare organizations, and community leaders to implement strategies to sustain successful program outcomes through policy changes at the system and statewide level by advocating for doula coverage and healthcare system sustainability of the integrated prenatal care model.
- Conditions
- Pregnancy Related
- Being tested
- BUNDLE, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUNDLEOther
An integrated model of community-based doulas and clinical obstetric providers
Usual CareOther
Standard of care for pregnancy and pregnancy-related issues by the obstetric provider
| Study group | Role | What they receive |
|---|---|---|
| BUNDLE Intervention | Experimental | Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction. Receives: Other: BUNDLE |
| Usual Care | Active comparator | Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Healthcare Engagement
A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least ~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.
Measured: From study enrollment and until 12 months postpartum
Secondary outcomes (9)
Trust in Provider
A validated 11-item instrument used to measure patients' trust in the provider regarding dependability, confidence, and confidentiality of information.
Measured: Baseline; third trimester, and postpartum
Reported Discrimination
Measured with a validated survey of patient self-report on how often in the past 12 months, individuals felt treated poorly due to race.
Measured: Baseline, third trimester and postpartum
Perceived Stress
Measured with Cohen's Perceived Stress Scale
Measured: Baseline, third trimester and postpartum
Depression
Measured with the Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline, third trimester and postpartum
Cesarean birth
Cesarean birth for any indication other than prior cesarean
Measured: At study completion
Unplanned healthcare utilization
Prenatal or postpartum (up to 12 weeks postpartum) unplanned emergency room visits or hospitalizations.
Measured: Up to 12 months postpartum
Severe Maternal Morbidity
Composite outcome of the following diagnoses using ICD-10 codes: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, disseminated intravascular coagulation, eclampsia, heart failure, puerperal cerebrovascular disorders, pulmonary edema, severe anesthesia complications, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism blood products transfusion, hysterectomy, temporary tracheostomy, ventilation.
Measured: Up to 12 months postpartum
Breastfeeding Initiation
Rates of breastfeeding initiation prior to discharge from the hospital
Measured: Up to 12 months postpartum
Group-Based Medical Mistrust Scale
A 12-item validated survey focused on healthcare provided in the social context of racism and discrimination.
Measured: Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start2 Jan 2025
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Palatnik, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993689
- Sponsor's protocol ID
- PRO00047801
- Acronym
- BUNDLE
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
- ClinicalTrials.gov ID
- NCT05993689
- Acronym / sponsor ID
- BUNDLE / PRO00047801
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 15 Aug 2023 (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.
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.
Detailed description
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The investigators will pursue the following aims using a multidisciplinary team of experts in health disparities, community engagement, qualitative research, maternal-fetal medicine, and doula support:
Aim 1: Develop an integrated prenatal care model of medical providers and community doulas in Southeastern Wisconsin Approach: The investigators will conduct six focus groups with 30 Black/AA birthing people (currently pregnant or recently postpartum) and 30 prenatal healthcare providers (obstetricians, midwives, doulas, social workers, prenatal care coordinators, nurses, mental health providers, and obstetric unit leaders) to elicit feedback on models of doula/medical provider integration with the overarching aim of building trust and improving maternal health outcomes. Focus group findings will be reviewed with a community advisory panel (CAP) developed as part of the Community Partnership of the MCW U54 center, to gain the CAP's input on intervention development.
Aim 2: Compare the effectiveness of the integrated prenatal care model to standard prenatal care in improving healthcare engagement and trust and reducing adverse maternal outcomes Approach: In a two-arm randomized controlled trial conducted at Froedtert and MCW, the investigators will randomize 412 Black/AA pregnant people to BUNDLE or standard prenatal care. Primary outcome is healthcare engagement (starting prenatal care in 1st trimester, attending at least 70% of the recommended visits, attending the postpartum visit, and receipt of recommended vaccination during pregnancy). Secondary outcomes include medical mistrust measured by trust in provider scale, perceived discrimination, and frequencies of severe maternal morbidity as defined by the Centers for Disease Control.
Aim 3: Disseminate findings to scholarly and community-based forums and actively pursue opportunities for systems- and policy-level change Approach: The investigators will disseminate findings regularly in scholarly (conference, grand rounds) and community-based (listening session, town hall) forums. The investigators will leverage the existing partnerships with policymakers, healthcare organizations, and community leaders to implement strategies to sustain successful program outcomes through policy changes at the system and statewide level by advocating for doula coverage and healthcare system sustainability of the integrated prenatal care model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUNDLE Intervention | Experimental | Other: BUNDLEProposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction. |
| Usual Care | Active comparator | Other: Usual CareStandard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine. |
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)
- Self-reported Black or African American
- Pregnant with singleton gestation
- Has an established OBGY at Froedtert \& the Medical College of Wisconsin (F\&MCW) Health System
Key exclusion criteria (3 listed)
- Planning to deliver outside of F\&MCW Health System
- Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula
- Inability or unwillingness to provide informed consent
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 |
|---|---|---|
| BUNDLEAn integrated model of community-based doulas and clinical obstetric providers | Other | BUNDLE Intervention |
| Usual CareStandard of care for pregnancy and pregnancy-related issues by the obstetric provider | Other | Usual Care |
Primary outcome
Perinatal Healthcare Engagement
Time frame: From study enrollment and until 12 months postpartum
A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least ~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.
9 secondary outcomes
Trust in Provider
Time frame: Baseline; third trimester, and postpartum
Reported Discrimination
Time frame: Baseline, third trimester and postpartum
Perceived Stress
Time frame: Baseline, third trimester and postpartum
Depression
Time frame: Baseline, third trimester and postpartum
Cesarean birth
Time frame: At study completion
Unplanned healthcare utilization
Time frame: Up to 12 months postpartum
Severe Maternal Morbidity
Time frame: Up to 12 months postpartum
Breastfeeding Initiation
Time frame: Up to 12 months postpartum
Group-Based Medical Mistrust Scale
Time frame: Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)
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 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUNDLE in people with Pregnancy Related, run by Medical College of Wisconsin 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 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
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 Anna Palatnik, MD ((414) 805-6624, apalatnik@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Healthcare Engagement (time frame: From study enrollment and until 12 months postpartum). 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 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.