Morbidity;PerinatalENHANCEDNCT06245057
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
A study testing Maternity care home model (MCHM) in people with Morbidity;Perinatal, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbidity;Perinatal
- What is being tested?
- Maternity care home model (MCHM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2024to 31 Jan 2028
- 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
- Ages 16-55
- Presentation to the hospital in pregnancy - this includes prenatal care or the emergency department
- Plan to deliver at the 2 Penn hospital sites
- Patients must be able to read and understand English or Spanish
- Participants must be willing and able to sign the informed consent form
Who cannot join
- Unable to provide written consent by being unable to read or sign informed consent.
- Enrolled in ENHANCED Trial in a prior pregnancy
- Already participating in Maternity Care Home Model (MCHM)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Phialdelphia, Pennsylvania, 19104
Elizabeth Norton, MPH, MBE, 215-349-5277, elizabeth.norton@pennmedicine.upenn.edu
Meaghan McCabe, MPH, 215-349-5277, meaghan.mccabe@pennmedicine.upenn.edu
- Not yet recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Elizabeth Norton, MPH, MBE, 215-349-5277, elizabeth.norton@pennmedicine.upenn.edu
Meaghan McCabe, MPH, 215-349-5277, meaghan.mccabe@pennmedicine.upenn.edu
About this study
Official title: The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients.
The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM.
Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum.
Read the detailed description
This randomized controlled trial addresses social and structural inequities to reduce severe maternal morbidity (SMM) and maternal mortality in the most at-risk patients - those that self-identify as Black, indigenous and people of color (BIPOC). Specifically, the intervention will implement and evaluate an integrated, multi-level maternity care home model (MCHM) that incorporates maternity care navigation, benefits navigation, social work, doula and mental health resources all within one care-delivery model. While previous studies have evaluated single social determinants (e.g. education and insurance) or single solutions (e.g. care navigator), these approaches lack a comprehensive, integrated approach that is responsive to all patient needs.
The study will test the central hypothesis that a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable BIPOC patients, thereby reducing SMM. To test the effectiveness of this MCHM and ensure timely uptake of the results, the investigators propose a type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness and implementation of an integrated MCHM that provides a comprehensive approach by partnering a unified model of social and structural service delivery with medical service delivery in all prenatal offices affiliated with the two largest birthing hospitals in Philadelphia.
Within this study, the investigators will determine the effectiveness of an integrated MCHM in reducing SMM among BIPOC patients (Aim 1). Patients will be randomized (n=2300) to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed throughout pregnancy and for 1 year postpartum. To determine mechanisms by which this integrated MCHM impacts SMM (Sub-Aim 1a), the investigators will evaluate numerous factors that could plausibly mitigate the effects of health system failures, provider bias and adverse social conditions (e.g. improved health system access, care coordination). The investigators will also characterize patient, provider and organizational implementation determinants relevant to an integrated MCHM and identify barriers and facilitators to implementation and sustainability (Aim 2) as well as determine resource utilization and total cost/cost savings associated with the MCHM (Sub-Aim 2a) by partnering with commercial and Medicaid payers.
Importantly, the results of the proposed study will provide actionable evidence to support effective maternity care delivery that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal, intrapartum and postpartum care is delivered and experienced. Additionally, even if the trial is negative in reducing SMM, there are still numerous other potential benefits to an integrated MCHM (including many of the secondary outcomes being evaluated) and the investigators will have therefore collected valuable information to inform the implementation of this model into clinical practice.
- Conditions
- Morbidity;Perinatal
- Being tested
- Maternity care home model (MCHM)
- Keywords
- Prenatal care, Disparity, Maternity care home model, Pregnancy home, Severe maternal morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternity care home model (MCHM)Other
The maternity care home model is defined as office based prenatal care integrated with comprehensive social services.
| Study group | Role | What they receive |
|---|---|---|
| Maternity care home model (MCHM) | Experimental | Office based prenatal care integrated with comprehensive social services within the maternity care home model. Receives: Other: Maternity care home model (MCHM) |
| Usual care arm | No intervention | Office based prenatal care with individually outsourced social service referrals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Maternal Morbidity (SMM)
The CDC definition of SMM. We will also include postpartum hemorrhage, infection, thrombosis, readmission and maternal mortality within this definition
Measured: Delivery to one year postpartum
Secondary outcomes (13)
Obstetric outcomes: Mode of delivery
Vaginal or cesarean
Measured: At delivery
Obstetric outcomes: Preterm birth less than 37 weeks
Preterm delivery defined as less than 37 weeks
Measured: At delivery
Obstetric outcomes: Preterm birth less than 34 weeks
Preterm delivery defined as less than 34 weeks.
Measured: At delivery
Obstetric outcomes: Hypertensive disorders of pregnancy
Diagnosis of Gestational hypertension, preeclampsia with or without severe features
Measured: During pregnancy through 6 weeks postpartum
Composite adverse neonatal outcome
Made up of one or more of the following: severe respiratory distress syndrome, Culture proven/presumed neonatal sepsis, Neonatal blood transfusion, Hypoxic ischemic encephalopathy, Intraventricular hemorrhage grade 3 or 4, Necrotizing enterocolitis, Need for head cooling,
Measured: From birth until 4 months after birth
Postpartum visit attendance
Whether or not the patient attended their routine postpartum visit up to 12 weeks postpartum mark.
Measured: From delivery discharge up to 12 weeks postpartum
Edinburgh Postnatal Depression Scale (EPDS) Screening
Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen
Measured: At delivery and at 3-6 months postpartum
Unscheduled Emergency room/pregnancy triage visits
Record number of unscheduled visits, reason for visit, whether or not patient was admitted to hospital.
Measured: Post-randomization to 1 year postpartum
Perceived stress scale
Scores from the validated Perceived Stress Scale (PSS-4) will be calculated using standard scoring criteria for each of the 4 items. Higher scores are correlated with more perceived stress.
Survey to be completed at randomization, at delivery, at 3 months post partum, and at 1 year post partum.
Measured: Post-randomization to 1 year postpartum
Person centered prenatal care survey for people of color
Scores from this 34-item scale will be calculated using standard scoring criteria. This scale measures person-centered prenatal care that reflects the experiences of people of color.
Measured: After delivery up to 6 weeks postpartum
Rate of Lactation initiation and continuation
Initiation of breastfeeding; Continuation of breastfeeding through 1 year postpartum. To be assessed by EMR documentation and patient report at 3-months and 1 year postpartum.
Measured: From delivery through 1 year postpartum
Perceived discrimination
Perceived discrimination will be assessed using the Experiences of Discrimination measure (Krieger et al, 2005). The measure lists 9 situations in which respondent may have experienced racial discrimination. Responses options are Yes/No. It is scored by counting the number of situations in which participant reported experiencing racial discrimination. Score ranges from 0 to 9, higher being more experiences of discrimination.
Measured: At randomization
Birth satisfaction (BSS-R survey)
Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction
Measured: After delivery up to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start30 Jan 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidity;PerinatalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sindhu Srinivas, MD, University of Pennsylvania
- Investigators
- Sindhu K Srinivas, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245057
- Sponsor's protocol ID
- 853430
- Other IDs
- 1R01NR020975-01
- Acronym
- ENHANCED
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2024
- Last updated
- 21 Apr 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
- ClinicalTrials.gov ID
- NCT06245057
- Acronym / sponsor ID
- ENHANCED / 853430
- Conditions
- Morbidity;Perinatal
- Keywords
- Prenatal care, Disparity, Maternity care home model, Pregnancy home, Severe maternal morbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 7 Feb 2024 (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 goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients.
The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM.
Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum.
Detailed description
This randomized controlled trial addresses social and structural inequities to reduce severe maternal morbidity (SMM) and maternal mortality in the most at-risk patients - those that self-identify as Black, indigenous and people of color (BIPOC). Specifically, the intervention will implement and evaluate an integrated, multi-level maternity care home model (MCHM) that incorporates maternity care navigation, benefits navigation, social work, doula and mental health resources all within one care-delivery model. While previous studies have evaluated single social determinants (e.g. education and insurance) or single solutions (e.g. care navigator), these approaches lack a comprehensive, integrated approach that is responsive to all patient needs.
The study will test the central hypothesis that a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable BIPOC patients, thereby reducing SMM. To test the effectiveness of this MCHM and ensure timely uptake of the results, the investigators propose a type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness and implementation of an integrated MCHM that provides a comprehensive approach by partnering a unified model of social and structural service delivery with medical service delivery in all prenatal offices affiliated with the two largest birthing hospitals in Philadelphia.
Within this study, the investigators will determine the effectiveness of an integrated MCHM in reducing SMM among BIPOC patients (Aim 1). Patients will be randomized (n=2300) to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed throughout pregnancy and for 1 year postpartum. To determine mechanisms by which this integrated MCHM impacts SMM (Sub-Aim 1a), the investigators will evaluate numerous factors that could plausibly mitigate the effects of health system failures, provider bias and adverse social conditions (e.g. improved health system access, care coordination). The investigators will also characterize patient, provider and organizational implementation determinants relevant to an integrated MCHM and identify barriers and facilitators to implementation and sustainability (Aim 2) as well as determine resource utilization and total cost/cost savings associated with the MCHM (Sub-Aim 2a) by partnering with commercial and Medicaid payers.
Importantly, the results of the proposed study will provide actionable evidence to support effective maternity care delivery that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal, intrapartum and postpartum care is delivered and experienced. Additionally, even if the trial is negative in reducing SMM, there are still numerous other potential benefits to an integrated MCHM (including many of the secondary outcomes being evaluated) and the investigators will have therefore collected valuable information to inform the implementation of this model into clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternity care home model (MCHM) | Experimental | Other: Maternity care home model (MCHM)Office based prenatal care integrated with comprehensive social services within the maternity care home model. |
| Usual care arm | No intervention | –Office based prenatal care with individually outsourced social service referrals. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
- Ages 16-55
- Presentation to the hospital in pregnancy - this includes prenatal care or the emergency department
- Plan to deliver at the 2 Penn hospital sites
- Patients must be able to read and understand English or Spanish
Key exclusion criteria (3 listed)
- Unable to provide written consent by being unable to read or sign informed consent.
- Enrolled in ENHANCED Trial in a prior pregnancy
- Already participating in Maternity Care Home Model (MCHM)
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 |
|---|---|---|
| Maternity care home model (MCHM)The maternity care home model is defined as office based prenatal care integrated with comprehensive social services. | Other | Maternity care home model (MCHM) |
Primary outcome
Severe Maternal Morbidity (SMM)
Time frame: Delivery to one year postpartum
The CDC definition of SMM. We will also include postpartum hemorrhage, infection, thrombosis, readmission and maternal mortality within this definition
13 secondary outcomes
Obstetric outcomes: Mode of delivery
Time frame: At delivery
Obstetric outcomes: Preterm birth less than 37 weeks
Time frame: At delivery
Obstetric outcomes: Preterm birth less than 34 weeks
Time frame: At delivery
Obstetric outcomes: Hypertensive disorders of pregnancy
Time frame: During pregnancy through 6 weeks postpartum
Composite adverse neonatal outcome
Time frame: From birth until 4 months after birth
Postpartum visit attendance
Time frame: From delivery discharge up to 12 weeks postpartum
Edinburgh Postnatal Depression Scale (EPDS) Screening
Time frame: At delivery and at 3-6 months postpartum
Unscheduled Emergency room/pregnancy triage visits
Time frame: Post-randomization to 1 year postpartum
Perceived stress scale
Time frame: Post-randomization to 1 year postpartum
Person centered prenatal care survey for people of color
Time frame: After delivery up to 6 weeks postpartum
Rate of Lactation initiation and continuation
Time frame: From delivery through 1 year postpartum
Perceived discrimination
Time frame: At randomization
Birth satisfaction (BSS-R survey)
Time frame: After delivery up to 6 weeks 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 21 Apr 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.
Sindhu K Srinivas, MD, MSCE 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 Maternity care home model (MCHM) in people with Morbidity;Perinatal, 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 6 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 21 Apr 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 Sindhu K Srinivas, MD, MSCE (215-662-2982, ssrinivas@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Maternal Morbidity (SMM) (time frame: Delivery to one year 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 21 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.