Severe Maternal MorbidityNCT05678699
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
A study testing Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) and Doula in people with Severe Maternal Morbidity and Maternal Death, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this study is to learn about the effects of Medicaid policy interventions on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are: 1. What is the effect of Medicaid healthcare quality interventions on SMM? 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Severe Maternal Morbidity, Maternal Death
- What is being tested?
- Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) and Doula
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant and postpartum Medicaid beneficiaries across the US
- Qualitative:
- Medicaid beneficiaries who identify as being at risk for poor outcomes or live in PA Health Equity Zones
- Doulas who provide care to Medicaid beneficiaries in Pennsylvania
- Medicaid Managed Care Organization (MCO) administrators in Pennsylvania. Severe maternal morbidity and mortality outcomes will be assessed in healthcare records and for these quantitative outcomes, patients will not be recruited individually
Who cannot join
- -
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
University of Pittsburgh School of Public Health
Pittsburgh, Pennsylvania, 15261
Dara D Mendez, PhD, 4126485664, ddm11@pitt.edu
Marquita Smalls, MPH, 4123830574, mns69@pitt.edu
About this study
The goal of this study is to learn about the effects of Medicaid policy interventions on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are:
- What is the effect of Medicaid healthcare quality interventions on SMM?
- What is the effect of Medicaid healthcare quality interventions + doula care?
- What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services?
Participants will be asked to describe experiences as a result of Medicaid policy interventions and focused Medicaid policies.
- Conditions
- Severe Maternal Morbidity, Maternal Death
- Being tested
- Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment), Doula, Standard Care
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment)Behavioural
This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2.
- incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes.
DoulaBehavioural
This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2.
- Incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes.
- care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania.
Standard CareBehavioural
Participants receive standard care without quality interventions or doula care
| Study group | Role | What they receive |
|---|---|---|
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only | Other | The investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates will decline among populations at risk after the interventions (incentive payment and obstetric bundled payment) within Pennsylvania (PA); and H2: SMM will decline among those exposed to the interventions in PA, relative to those in similar states. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare interventions on beneficiaries' experiences. Receives: Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment); Behavioral: Standard Care |
| Doula Only | Other | The investigators will test two hypotheses: H1: SMM rates will decline among populations at risk after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: SMM will decline more among those exposed to both healthcare quality and doula care interventions in PA, relative to states implementing doula care only. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare and service interventions on beneficiaries' experiences. Receives: Behavioral: Doula; Behavioral: Standard Care |
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula | Other | Not described Receives: Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment); Behavioral: Doula; Behavioral: Standard Care |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe maternal morbidity (SMM)
SMM rate based on the Centers for Disease Control algorithm
Measured: 20 weeks gestation through 42 days postpartum
Secondary outcomes (4)
All cause mortality
Binary indicator of mortality based on Social Security Administration records
Measured: Delivery date through one year after delivery
Follow up for chronic conditions
Percent of persons who receive guideline concordant care for depression, substance use disorders, immunizations, and screening and referral for social determinants of health
Measured: 43 days through 1 year after delivery
Provision of evidence care in pregnancy and postpartum
Percent of Medicaid patients among each provider who receive screening and follow up for depression, treatment for substance use disorders, perinatal immunizations, and screening and referral for social determinants of health
Measured: During pregnancy and postpartum up to 1 year
Medicaid managed care administrator perspectives on policy interventions
Qualitative self report of perspectives
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start3 Jan 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Maternal MorbidityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Evaluation of policy interventions at the state level comparing within state and across states over time.
- Masking
- None (open label)
- Enrolment
- 10,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Dara Mendez, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678699
- Sponsor's protocol ID
- STUDY22080184
- Other IDs
- 1R01NR020670-01
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
- ClinicalTrials.gov ID
- NCT05678699
- Acronym / sponsor ID
- STUDY22080184
- Conditions
- Severe Maternal Morbidity, Maternal Death
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000,000 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Jan 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 goal of this study is to learn about the effects of Medicaid policy interventions on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are:
- What is the effect of Medicaid healthcare quality interventions on SMM?
- What is the effect of Medicaid healthcare quality interventions + doula care?
- What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services?
Participants will be asked to describe experiences as a result of Medicaid policy interventions and focused Medicaid policies.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Evaluation of policy interventions at the state level comparing within state and across states over time.
| Arm | Type | Receives |
|---|---|---|
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only | Other | Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment), Behavioral: Standard CareThe investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates will decline among populations at risk after the interventions (incentive payment and obstetric bundled payment) within Pennsylvania (PA); and H2: SMM will decline among those exposed to the interventions in PA, relative to those in similar states. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare interventions on beneficiaries' experiences. |
| Doula Only | Other | Behavioral: Doula, Behavioral: Standard CareThe investigators will test two hypotheses: H1: SMM rates will decline among populations at risk after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: SMM will decline more among those exposed to both healthcare quality and doula care interventions in PA, relative to states implementing doula care only. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare and service interventions on beneficiaries' experiences. |
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula | Other | Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment), Behavioral: Doula, Behavioral: Standard Care |
| Standard Care | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant and postpartum Medicaid beneficiaries across the US
- Medicaid beneficiaries who identify as being at risk for poor outcomes or live in PA Health Equity Zones
- Doulas who provide care to Medicaid beneficiaries in Pennsylvania
- Medicaid Managed Care Organization (MCO) administrators in Pennsylvania. Severe maternal morbidity and mortality outcomes will be assessed in healthcare records and for these quantitative outcomes, patients will not be recruited individually
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment)This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2. 1) incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes. | Behavioural | Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula, Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only |
| DoulaThis study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2. 1. Incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes. 2. care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania. | Behavioural | Doula Only, Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula |
| Standard CareParticipants receive standard care without quality interventions or doula care | Behavioural | Doula Only, Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula, Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only |
Primary outcome
Severe maternal morbidity (SMM)
Time frame: 20 weeks gestation through 42 days postpartum
SMM rate based on the Centers for Disease Control algorithm
4 secondary outcomes
All cause mortality
Time frame: Delivery date through one year after delivery
Follow up for chronic conditions
Time frame: 43 days through 1 year after delivery
Provision of evidence care in pregnancy and postpartum
Time frame: During pregnancy and postpartum up to 1 year
Medicaid managed care administrator perspectives on policy interventions
Time frame: Year 3
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 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) and Doula in people with Severe Maternal Morbidity and Maternal Death, run by University of Pittsburgh 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 5 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: looking for participants now, as of the sponsor's last update on 10 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe maternal morbidity (SMM) (time frame: 20 weeks gestation through 42 days 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 10 Sep 2026.