An interventional study of Enhanced Postpartum Care System in Maternal Death and Maternal Morbidity, sponsored by Emory University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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.
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's enrollment of 320 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Enhanced Postpartum Care System
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.
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.
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.
Time frame: 12 weeks after delivery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks after delivery
Number of Participants Using Contraception
The number of participants using contraception is evaluated via patient self-report survey.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 months after delivery
| Milestone | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Started | 159 | 161 |
| Completed assessment at 12 weeks post-delivery | 141 | 141 |
| Completed | 124 | 117 |
| Not completed | 35 | 44 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Number of Participants Attending a Comprehensive Postpartum Visit | 84 | 89 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Number of Participants Attending Any Postpartum Visit | 109 | 116 |
Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Postpartum diabetes screening ordered | 18 | 26 |
| Postpartum diabetes screening not ordered | 141 | 135 |
Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Postpartum diabetes screening completed | 9 | 14 |
| Postpartum diabetes screening not completed | 150 | 147 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Postpartum diabetes screening ordered | 14 | 19 |
| Postpartum diabetes screening not ordered | 22 | 26 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Postpartum diabetes screening completed | 8 | 11 |
| Postpartum diabetes screening not completed | 28 | 34 |
Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Number of Participants Receiving Postpartum Hypertension Screening | 80 | 81 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Number of Participants With Hypertension Receiving Postpartum Hypertension Screening | 45 | 48 |
The number of participants using contraception is evaluated via patient self-report survey.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| 12 weeks after delivery | 119 | 117 |
| 14 months after delivery | 86 | 85 |
The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| 12 weeks after delivery | 21 | 29 |
| 14 months after delivery | 17 | 9 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| 12 weeks after delivery | 2 | 3 |
| 14 months after delivery | 4 | 8 |
The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| 12 weeks after delivery | 6 | 10 |
| 14 months after delivery | 16 | 20 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Perceived risk value - low risk | 35 | 34 |
| Perceived risk value - average or high risk | 66 | 76 |
| Don't know/refused to answer/missing response | 40 | 31 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| 12 weeks after delivery — Low risk | 55 | 58 |
| 12 weeks after delivery — Average or high risk | 26 | 31 |
| 12 weeks after delivery — Don't know/refused to answer/missing response | 60 | 52 |
| 14 months after delivery — Low risk | 52 | 55 |
| 14 months after delivery — Average or high risk | 30 | 21 |
| 14 months after delivery — Don't know/refused to answer/missing response | 42 | 41 |
The number of participants attending a visit with a primary care provider is evaluated via medical record abstraction 14 months after delivery.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Number of Participants Using Primary Care | 73 | 79 |
The number of participants attending a visit with a specialty health care provider is evaluated via medical record abstraction 14 months after delivery.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Number of Participants Using Specialty Care | 94 | 73 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| 12 weeks after delivery — EPDS score of 13 or higher | 37 | 26 |
| 12 weeks after delivery — EPDS score of less than 13 | 88 | 92 |
| 12 weeks after delivery — Refused to answer/missing response | 16 | 23 |
| 14 months after delivery — EPDS score of 13 or higher | 27 | 16 |
| 14 months after delivery — EPDS score of less than 13 | 84 | 83 |
| 14 months after delivery — Refused to answer/missing response | 13 | 18 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Satisfied with wait time | 88 | 81 |
| Satisfied with amount of time with healthcare providers | 90 | 79 |
| Satisfied with advice given | 91 | 82 |
| Satisfied with respect shown to each individual as a person | 93 | 87 |
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.
| units on a scale | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Respected me as a person | 4.7 ± 0.6 | 4.7 ± 0.5 |
| Letting me say what mattered to me about my health | 4.7 ± 0.6 | 4.6 ± 0.8 |
| Taking my preferences seriously | 4.7 ± 0.7 | 4.6 ± 0.8 |
| Giving me enough information to make the best decisions about my health | 4.7 ± 0.6 | 4.6 ± 0.9 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Physical Health Since Delivery — Excellent | 47 | 50 |
| Physical Health Since Delivery — Very Good | 18 | 23 |
| Physical Health Since Delivery — Good | 43 | 32 |
| Physical Health Since Delivery — Fair | 23 | 24 |
| Physical Health Since Delivery — Declined | 1 | 2 |
| Physical Health Since Delivery — Poor | 5 | 3 |
| Physical Health Since Delivery — Missing response/refused to answer | 4 | 7 |
| Mental health since delivery — Excellent | 49 | 53 |
| Mental health since delivery — Very Good | 21 | 22 |
| Mental health since delivery — Good | 26 | 29 |
| Mental health since delivery — Fair | 28 | 24 |
| Mental health since delivery — Declined | 6 | 3 |
| Mental health since delivery — Poor | 8 | 9 |
| Mental health since delivery — Missing response/refused to answer | 3 | 1 |
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.
| Participants | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Excellent | 31 | 29 |
| Very good | 23 | 31 |
| Good | 41 | 33 |
| Fair | 25 | 21 |
| Poor | 4 | 2 |
| Missing/refused | 0 | 1 |
Collected over Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Postpartum Care System | 0/159 (0%) | 6/159 (3.8%) | 39/159 (24.5%) |
| Standard of Care | 0/161 (0%) | 10/161 (6.2%) | 27/161 (16.8%) |
| Event | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Inpatient hospitalization through 12 weeks postpartum for preeclampsiaPregnancy, puerperium and perinatal conditions | 4/159 | 2/161 |
| Inpatient hospitalization through 12 weeks postpartum for sepsisPregnancy, puerperium and perinatal conditions | 2/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for eclampsiaPregnancy, puerperium and perinatal conditions | 0/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for cerebral hemorrhagePregnancy, puerperium and perinatal conditions | 0/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for endometritisReproductive system and breast disorders | 0/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for cholecystitisHepatobiliary disorders | 0/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for small bowel obstructionGastrointestinal disorders | 0/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for colostomy reversalSurgical and medical procedures | 0/159 | 1/161 |
| Inpatient hospitalization through 12 weeks postpartum for diabetic ketoacidosisEndocrine disorders | 0/159 | 1/161 |
| Event | Enhanced Postpartum Care System | Standard of Care |
|---|---|---|
| Acute upper respiratory, skin, or dental infectionInfections and infestations | 10/159 | 6/161 |
| HypertensionVascular disorders | 7/159 | 6/161 |
| Wound dehiscence or minor infectionSurgical and medical procedures | 6/159 | 5/161 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 5/159 | 4/161 |
| Genitourinary infectionInfections and infestations | 4/159 | 0/161 |
| Mental health issuesPsychiatric disorders | 3/159 | 0/161 |
| Chronic condition exacerbationGeneral disorders | 3/159 | 2/161 |
| Breastfeeding issuesPregnancy, puerperium and perinatal conditions | 2/159 | 2/161 |
| Acute cholecystitisHepatobiliary disorders | 2/159 | 0/161 |
| Vaginal bleedingReproductive system and breast disorders | 1/159 | 2/161 |
| Age, Customized(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| 18-24 | 42 | 37 | 79 |
| 25-34 | 81 | 78 | 159 |
| 35-45 | 36 | 46 | 82 |
| Sex: Female, Male(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| Female | 159 | 161 | 320 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 23 | 46 |
| Not Hispanic or Latino | 136 | 138 | 274 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 133 | 131 | 264 |
| White | 3 | 5 | 8 |
| More than one race | 23 | 24 | 47 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| United States | 159 | 161 | 320 |
| Type of health insurance at delivery(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| Medicaid/Medicare | 119 | 132 | 251 |
| Private insurance | 35 | 27 | 62 |
| Self-pay | 1 | 1 | 2 |
| Unknown | 4 | 1 | 5 |
| Gestational age at study enrollment(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| 20-27 weeks | 98 | 97 | 195 |
| 28-34 weeks | 61 | 64 | 125 |
| Documented diagnoses(Participants) | Enhanced Postpartum Care System | Standard of Care | Total |
|---|---|---|---|
| Chronic hypertension | 70 | 70 | 140 |
| Diabetes mellitus | 18 | 21 | 39 |
| Pre-pregnancy obesity | 79 | 70 | 149 |
| Gestational diabetes | 18 | 24 | 42 |
| Hypertensive disorders of pregnancy | 6 | 8 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol
Time frame: Data will become available one year after study completion (starting May 1, 2025) and will be made available for 5 years (through April 30, 2030).
Access criteria: The researchers will make the data and associated documentation available to users under a data-sharing agreement. Outside researchers must submit a Data Analysis Request Form, which requires elucidation of the specific data requested along with a statement that the investigator must provide: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The Data Analysis Request Form will be made web-accessible with directions to submit the request for review. Outside investigators must have satisfactorily completed a Data Use and Confidentiality Agreement, before the anonymized data is released.
Ran from Aug 2022 to primary completion in Jul 2024, 23 months.
Results were first posted in Aug 2025, 1 year after primary completion.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.