Maternal DeathNCT05430815
Improving Women's Health Through Coordinated Postpartum Planning
A study testing Enhanced Postpartum Care System in people with Maternal Death and Maternal Morbidity, run by Emory University at 1 site in United States.
Trial summary
The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Death, Maternal Morbidity
- What is being tested?
- Enhanced Postpartum Care System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women between 20-34 weeks of gestation
- have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
- intend to deliver at Grady Memorial Hospital
- speak English or Spanish
- have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index [BMI] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)
Who cannot join
- adults unable to consent, infants, and prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning
The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.
Read the detailed description
The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 live births. Among the states, Georgia has the second highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white women (95.6 vs 59.7 per 100,000). Nearly 100 times more common than maternal mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor and delivery that result in short- and long-term deleterious health consequences. Maternal mortality and SMM are highest among women who are black, publicly insured or uninsured, and deliver in safety-net hospitals. In Georgia, 66% of maternal deaths occur to women insured by Medicaid at delivery and the majority of deaths and SMM occur postpartum, a time during which healthcare visits are poorly attended and oftentimes inaccessible. The Georgia Maternal Mortality Review Committee concluded that two-thirds of maternal deaths are preventable, with chronic health conditions, obesity, delays in accessing and fragmentation of care as key contributors. As solutions, it recommends improved prenatal and postpartum follow-up and case management, control of chronic health conditions, and extension of Medicaid coverage beyond 60 days postpartum.
While the postpartum period represents a crucial window of opportunity for promoting women's current and future health, up to 40% of US women do not attend postpartum visits due to structural barriers (e.g., lack of insurance, transportation or childcare) social barriers (e.g., medical mistrust and poor patient-provider relationships) or low perceived utility of postpartum care. Moreover, the lowest rates of postpartum care utilization are concentrated among women with the highest rates of pregnancy complications and chronic conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic black). Timely and adequate use of postpartum care is especially important for women with diabetes or hypertensive disease as these conditions are associated with increased risk for postpartum morbidity and mortality and cardiovascular disease later in life.
The researchers of this study plan to conduct an intervention study to assess the effect of a woman-centered, comprehensive postpartum care system on postpartum visit attendance and follow-up care among medically underserved women with chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity or hypertensive disorder of pregnancy (HDP). Because implementing and sustaining a comprehensive postpartum care system in a health disparities population requires a thorough understanding of patient preferences regarding the structural and process elements of care, methods of provider-patient communication, and strategies for addressing social and contextual barriers to care the researchers will use in-depth interviews to inform the intervention design and then assess health outcomes and satisfaction.
- Conditions
- Maternal Death, Maternal Morbidity
- Being tested
- Enhanced Postpartum Care System
- Keywords
- Maternal mortality, Severe maternal morbidity, Postpartum 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.
Enhanced Postpartum Care SystemBehavioural
The intervention consists of a comprehensive postpartum care system that integrates American College of Obstetrician and Gynecologist's (ACOG) postpartum care guidelines together with American College of Cardiology and American Heart Association (ACC/AHA) guidelines for the prevention of cardiovascular disease in women, as well as patient preferences for care coordination and communication. The system consists of: 1) a tailored postpartum care plan that is collaboratively developed with patient and provider input and addresses both social and medical needs; 2) an electronic medical record (EMR) based tool for documenting the plan and monitoring postpartum care; and 3) a postpartum follow-up phone call at 1 week postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Postpartum Care System | Experimental | Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive enhanced postpartum care. Receives: Behavioral: Enhanced Postpartum Care System |
| Standard of Care | No intervention | Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive standard postpartum care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Attending a Comprehensive Postpartum Visit
The postpartum visit occurs between 4 and 12 weeks after delivery and is defined as a preventive care visit with an obstetric care provider (e.g., obstetrician-gynecologist, certified nurse midwife, or primary care provider with additional training relevant to postpartum care) that included an assessment of assessing multiple aspects of physical and mental health. Comprehensive postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Measured: 12 weeks after delivery
Secondary outcomes (20)
Number of Participants Attending Any Postpartum Visit
Any type of outpatient postpartum visit between 4 and 12 weeks after delivery other than visits to urgent care and/or emergency departments. Postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Measured: 12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered
Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records.
Measured: 12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Performed
Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records.
Measured: 12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered
Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records, among enrolled participants diagnosed with gestational diabetes or diabetes mellitus.
Measured: 12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed
Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records, among enrolled participants diagnosed with gestational diabetes or diabetes mellitus.
Measured: 12 weeks after delivery
Number of Participants Receiving Postpartum Hypertension Screening
Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records.
Measured: 12 weeks after delivery
Number of Participants With Hypertension Receiving Postpartum Hypertension Screening
Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records, among enrolled participants diagnosed with hypertensive disorders of pregnancy or chronic hypertension.
Measured: 12 weeks after delivery
Number of Participants Using Contraception
The number of participants using contraception is evaluated via patient self-report survey.
Measured: 12 weeks after delivery, 14 months after delivery
Number of Participants Using Medication
The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction.
Measured: 12 weeks after delivery, 14 months after delivery
Number of Participants With Ongoing Pregnancy Complications
The number of participants with diagnoses of severe maternal morbidity since the birth of their baby, identified from medical records using International Classification of Diseases diagnosis and any procedure codes from readmissions following the delivery.
Measured: 12 weeks after delivery, 14 months after delivery
Number of Participants Readmitted to the Hospital
The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
Measured: 12 weeks after delivery, 14 months after delivery
Perceived Risk of Severe Maternal Morbidity (SMM)
Future severe maternal morbidity risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a serious pregnancy complication during a future pregnancy compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Measured: 12 weeks after delivery
Perceived Risk of Cardiovascular Disease
Future cardiovascular disease risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a heart attack or stroke compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Measured: 12 weeks after delivery, 14 months after delivery
Number of Participants Using Primary Care
The number of participants attending a visit with a primary care provider is evaluated via medical record abstraction 14 months after delivery.
Measured: 14 months after delivery
Number of Participants Using Specialty Care
The number of participants attending a visit with a specialty health care provider is evaluated via medical record abstraction 14 months after delivery.
Measured: 14 months after delivery
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score
Depressive symptoms are assessed with the Edinburgh Postnatal Depression Scale (EPDS). The EPDS includes 10-items asking participants about symptoms of depression that they have experienced in the past 7 days. Responses are given on a 4-point scale where 0 corresponds with the least amount of symptoms and 3 corresponds with the highest amount of symptoms. Total scores range from 0 to 30 with higher scores indicating increased symptoms of depression. Scores of 13 or greater indicate that the respondent is likely suffering from depression.
Measured: 12 weeks after delivery, 14 months after delivery
Satisfaction With Postpartum Care
Satisfaction with the postpartum checkup is assessed by asking those participants who reported completing a postpartum visit if they were satisfied with the wait time, amount of time with healthcare providers, advice given, and respect shown to each individual as a person. Responses are given as "yes" or "no". The count of participants reporting satisfaction with each separate item is assessed.
Measured: 12 weeks after delivery
Satisfaction With Provider at Postpartum Care Visit
Satisfaction with the healthcare provider at the postpartum care visit is assessed with 4 items. Responses are given on a 5-point scale where 1 = poor and 5 = excellent. Each item is scored separately and higher scores indicate greater satisfaction with the healthcare provider.
Measured: 12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Participants are asked to self-rate their perception of their physical health and mental health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.
Measured: 12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery
Participants are asked to self-rate their perception of their current health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.
Measured: 14 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start8 Aug 2022
- Primary completion31 Jul 2024
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal DeathStudies of the same condition, open and under way.
- More trials run by Emory 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Anne Lang Dunlop, Emory University
- Investigators
- Anne Dunlop, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430815
- Sponsor's protocol ID
- STUDY00001427
- Other IDs
- 1R01MD016031
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2022
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final fully deidentified dataset that will be made available for sharing will include sociodemographic, health behavioral, and health care utilization data from both questionnaire and medical record abstraction, to include race/ethnicity, age, insurance type, visits to health care provider/clinic/or hospital within one year postpartum, including any diagnoses, medical testing and/or laboratory screenings (and results of those tests), prescribed medications and adherence to prescribed medications, as well as data related to any subsequently conceived pregnancy.
Publications
Boulet SL, Stanhope KK, Stallworth T, Juarez G, Lozada M, Geary F, Green VL, King T, Furst L, Vuncannon D, Newton-Levinson A, Jamieson DJ, Dunlop AL. Effect of a patient-centered planning intervention on postpartum visit attendance. Pregnancy (Hoboken). 2026 Jun 19;2(4):e70346. doi: 10.1002/pmf2.70346. eCollection 2026 Jul.
PubMed 42597009Stanhope KK, Stallworth T, Forrest AD, Vuncannon D, Juarez G, Boulet SL, Geary F, Dunlop AL, Blake SC, Green VL, Jamieson DJ. Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care. Contemp Clin Trials. 2024 Aug;143:107586. doi: 10.1016/j.cct.2024.107586. Epub 2024 Jun 3.
PubMed 38838985
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning
- ClinicalTrials.gov ID
- NCT05430815
- Acronym / sponsor ID
- STUDY00001427
- Conditions
- Maternal Death, Maternal Morbidity
- Keywords
- Maternal mortality, Severe maternal morbidity, Postpartum care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.
Detailed description
The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 live births. Among the states, Georgia has the second highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white women (95.6 vs 59.7 per 100,000). Nearly 100 times more common than maternal mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor and delivery that result in short- and long-term deleterious health consequences. Maternal mortality and SMM are highest among women who are black, publicly insured or uninsured, and deliver in safety-net hospitals. In Georgia, 66% of maternal deaths occur to women insured by Medicaid at delivery and the majority of deaths and SMM occur postpartum, a time during which healthcare visits are poorly attended and oftentimes inaccessible. The Georgia Maternal Mortality Review Committee concluded that two-thirds of maternal deaths are preventable, with chronic health conditions, obesity, delays in accessing and fragmentation of care as key contributors. As solutions, it recommends improved prenatal and postpartum follow-up and case management, control of chronic health conditions, and extension of Medicaid coverage beyond 60 days postpartum.
While the postpartum period represents a crucial window of opportunity for promoting women's current and future health, up to 40% of US women do not attend postpartum visits due to structural barriers (e.g., lack of insurance, transportation or childcare) social barriers (e.g., medical mistrust and poor patient-provider relationships) or low perceived utility of postpartum care. Moreover, the lowest rates of postpartum care utilization are concentrated among women with the highest rates of pregnancy complications and chronic conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic black). Timely and adequate use of postpartum care is especially important for women with diabetes or hypertensive disease as these conditions are associated with increased risk for postpartum morbidity and mortality and cardiovascular disease later in life.
The researchers of this study plan to conduct an intervention study to assess the effect of a woman-centered, comprehensive postpartum care system on postpartum visit attendance and follow-up care among medically underserved women with chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity or hypertensive disorder of pregnancy (HDP). Because implementing and sustaining a comprehensive postpartum care system in a health disparities population requires a thorough understanding of patient preferences regarding the structural and process elements of care, methods of provider-patient communication, and strategies for addressing social and contextual barriers to care the researchers will use in-depth interviews to inform the intervention design and then assess health outcomes and satisfaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Postpartum Care System | Experimental | Behavioral: Enhanced Postpartum Care SystemWomen with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive enhanced postpartum care. |
| Standard of Care | No intervention | –Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive standard postpartum care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant women between 20-34 weeks of gestation
- have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
- intend to deliver at Grady Memorial Hospital
- speak English or Spanish
- have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index [BMI] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)
Key exclusion criteria (1 listed)
- adults unable to consent, infants, and prisoners
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 |
|---|---|---|
| Enhanced Postpartum Care SystemThe intervention consists of a comprehensive postpartum care system that integrates American College of Obstetrician and Gynecologist's (ACOG) postpartum care guidelines together with American College of Cardiology and American Heart Association (ACC/AHA) guidelines for the prevention of cardiovascular disease in women, as well as patient preferences for care coordination and communication. The system consists of: 1) a tailored postpartum care plan that is collaboratively developed with patient and provider input and addresses both social and medical needs; 2) an electronic medical record (EMR) based tool for documenting the plan and monitoring postpartum care; and 3) a postpartum follow-up phone call at 1 week postpartum. | Behavioural | Enhanced Postpartum Care System |
Primary outcome
Number of Participants Attending a Comprehensive Postpartum Visit
Time frame: 12 weeks after delivery
The postpartum visit occurs between 4 and 12 weeks after delivery and is defined as a preventive care visit with an obstetric care provider (e.g., obstetrician-gynecologist, certified nurse midwife, or primary care provider with additional training relevant to postpartum care) that included an assessment of assessing multiple aspects of physical and mental health. Comprehensive postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
20 secondary outcomes
Number of Participants Attending Any Postpartum Visit
Time frame: 12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered
Time frame: 12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Performed
Time frame: 12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered
Time frame: 12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed
Time frame: 12 weeks after delivery
Number of Participants Receiving Postpartum Hypertension Screening
Time frame: 12 weeks after delivery
Number of Participants With Hypertension Receiving Postpartum Hypertension Screening
Time frame: 12 weeks after delivery
Number of Participants Using Contraception
Time frame: 12 weeks after delivery, 14 months after delivery
Number of Participants Using Medication
Time frame: 12 weeks after delivery, 14 months after delivery
Number of Participants With Ongoing Pregnancy Complications
Time frame: 12 weeks after delivery, 14 months after delivery
Number of Participants Readmitted to the Hospital
Time frame: 12 weeks after delivery, 14 months after delivery
Perceived Risk of Severe Maternal Morbidity (SMM)
Time frame: 12 weeks after delivery
Perceived Risk of Cardiovascular Disease
Time frame: 12 weeks after delivery, 14 months after delivery
Number of Participants Using Primary Care
Time frame: 14 months after delivery
Number of Participants Using Specialty Care
Time frame: 14 months after delivery
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score
Time frame: 12 weeks after delivery, 14 months after delivery
Satisfaction With Postpartum Care
Time frame: 12 weeks after delivery
Satisfaction With Provider at Postpartum Care Visit
Time frame: 12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Time frame: 12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery
Time frame: 14 months after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42597009Boulet SL, Stanhope KK, Stallworth T, Juarez G, Lozada M, Geary F, Green VL, King T, Furst L, Vuncannon D, Newton-Levinson A, Jamieson DJ, Dunlop AL. Effect of a patient-centered planning intervention on postpartum visit attendance. Pregnancy (Hoboken). 2026 Jun 19;2(4):e70346. doi: 10.1002/pmf2.70346. eCollection 2026 Jul.
- Derived from this study: PubMed 38838985Stanhope KK, Stallworth T, Forrest AD, Vuncannon D, Juarez G, Boulet SL, Geary F, Dunlop AL, Blake SC, Green VL, Jamieson DJ. Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care. Contemp Clin Trials. 2024 Aug;143:107586. doi: 10.1016/j.cct.2024.107586. Epub 2024 Jun 3.
- Individual participant dataSharing planned: Yes. The final fully deidentified dataset that will be made available for sharing will include sociodemographic, health behavioral, and health care utilization data from both questionnaire and medical record abstraction, to include race/ethnicity, age, insurance type, visits to health care provider/clinic/or hospital within one year postpartum, including any diagnoses, medical testing and/or laboratory screenings (and results of those tests), prescribed medications and adherence to prescribed medications, as well as data related to any subsequently conceived pregnancy.
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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.
Anne Dunlop, MD, MPH principal investigator
Emory 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 Enhanced Postpartum Care System in people with Maternal Death and Maternal Morbidity, run by Emory 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 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: finished, as of the sponsor's last update on 14 May 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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Attending a Comprehensive Postpartum Visit (time frame: 12 weeks after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430815, which also lists 2 linked publications.
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 14 May 2026.