Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD016031 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Postpartum Care System | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Dunlop, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38838985 | Derived | Stanhope 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. |
Not provided
Not provided
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.
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).
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.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Postpartum Care System | Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care. Enhanced Postpartum Care System 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. |
| FG001 | Standard of Care | 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 randomized to receive standard postpartum care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Postpartum Care System | Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
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.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Postpartum Care System | Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization through 12 weeks postpartum for sepsis | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Severe maternal morbidity event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Dunlop, MD, MPH | Emory University | 404-712-8520 | amlang@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2024 | Jul 28, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2023 | Jan 31, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Information on all outpatient visits occurring between delivery discharge and 12 weeks postpartum will be abstracted and blinded for review. Two independent physicians will review the blinded information and determine whether the visit meets the criteria for a comprehensive postpartum visit.
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 12 weeks after delivery |
| Number of Participants Using Contraception | The number of participants using contraception is evaluated via patient self-report survey. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 14 months after delivery |
| Standard of Care |
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 randomized to receive standard postpartum care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Type of health insurance at delivery | Count of Participants | Participants |
|
| Gestational age at study enrollment | Count of Participants | Participants |
|
| Documented diagnoses | Count of Participants | Participants |
|
| OG001 | Standard of Care | 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 randomized to receive standard postpartum care. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants diagnosed with gestational diabetes or diabetes mellitus. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants diagnosed with gestational diabetes or diabetes mellitus. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants diagnosed with hypertensive disorders of pregnancy or chronic hypertension. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | Number of Participants Using Contraception | The number of participants using contraception is evaluated via patient self-report survey. | This analysis includes participants who completed the assessment at the indicated study time points. | Posted | Count of Participants | Participants | 12 weeks after delivery, 14 months after delivery |
|
|
|
| Secondary | Number of Participants Using Medication | The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction. | Posted | Count of Participants | Participants | 12 weeks after delivery, 14 months after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery, 14 months after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after delivery, 14 months after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants who completed the assessment at 12 weeks post-delivery. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants who completed the assessment at the indicated study time point. | Posted | Count of Participants | Participants | 12 weeks after delivery, 14 months after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 14 months after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 14 months after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants who completed the assessment at 12 weeks post-delivery. | Posted | Count of Participants | Participants | 12 weeks after delivery, 14 months after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants who reported completing a postpartum visit. Some participants did not respond to every survey item. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants who reported completing a postpartum visit. Some participants did not respond to every survey item. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks after delivery |
|
|
|
| Secondary | 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. | This analysis includes participants who completed the assessment at 12 weeks post-delivery. | Posted | Count of Participants | Participants | 12 weeks after delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 14 months after delivery |
|
|
|
| 0 |
| 159 |
| 6 |
| 159 |
| 39 |
| 159 |
| EG001 | Standard of Care | 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 randomized to receive standard postpartum care. | 0 | 161 | 10 | 161 | 27 | 161 |
|
| Inpatient hospitalization through 12 weeks postpartum for preeclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Inpatient hospitalization through 12 weeks postpartum for eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Severe maternal morbidity event |
|
| Inpatient hospitalization through 12 weeks postpartum for cerebral hemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Severe maternal morbidity event |
|
| Inpatient hospitalization through 12 weeks postpartum for endometritis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Inpatient hospitalization through 12 weeks postpartum for cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Inpatient hospitalization through 12 weeks postpartum for small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Inpatient hospitalization through 12 weeks postpartum for colostomy reversal | Surgical and medical procedures | Non-systematic Assessment |
|
| Inpatient hospitalization through 12 weeks postpartum for diabetic ketoacidosis | Endocrine disorders | Non-systematic Assessment |
|
| Breastfeeding issues | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Mental health issues | Psychiatric disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| New pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Genitourinary infection | Infections and infestations | Non-systematic Assessment |
|
| Wound dehiscence or minor infection | Surgical and medical procedures | Non-systematic Assessment |
|
| Acute upper respiratory, skin, or dental infection | Infections and infestations | Non-systematic Assessment |
|
| Chronic condition exacerbation | General disorders | Non-systematic Assessment |
|
| Acute cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Family planning | Reproductive system and breast disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| 14 months after delivery |
|
|
| Don't know/refused to answer/missing response |
|
| Average or high risk |
|
| Don't know/refused to answer/missing response |
|
| 14 months after delivery |
|
|
| EPDS score of less than 13 |
|
| Refused to answer/missing response |
|
| 14 months after delivery |
|
|
| Satisfied with amount of time with healthcare providers |
|
|
| Satisfied with advice given |
|
|
| Satisfied with respect shown to each individual as a person |
|
|
| Letting me say what mattered to me about my health |
|
|
| Taking my preferences seriously |
|
|
| Giving me enough information to make the best decisions about my health |
|
|
| Good |
|
| Fair |
|
| Declined |
|
| Poor |
|
| Missing response/refused to answer |
|
| Mental health since delivery |
|
| Good |
|
| Fair |
|
| Poor |
|
| Missing/refused |
|