Maternal Death, Maternal Morbidity
Conditions
Keywords
Maternal mortality, Severe maternal morbidity, Postpartum care
Brief 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 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.
Interventions
BEHAVIORALEnhanced Postpartum Care System
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.
Sponsors
Emory University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* adults unable to consent, infants, and prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Attending a Comprehensive Postpartum Visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ongoing Pregnancy Complications | 12 weeks after delivery, 14 months after delivery | 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. |
| Number of Participants Readmitted to the Hospital | 12 weeks after delivery, 14 months after delivery | The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby. |
| Perceived Risk of Severe Maternal Morbidity (SMM) | 12 weeks after delivery | 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. |
| Perceived Risk of Cardiovascular Disease | 12 weeks after delivery, 14 months after delivery | 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. |
| Number of Participants Using Primary Care | 14 months after delivery | The number of participants attending a visit with a primary care provider is evaluated via medical record abstraction 14 months after delivery. |
| Number of Participants Using Specialty Care | 14 months after delivery | The number of participants attending a visit with a specialty health care provider is evaluated via medical record abstraction 14 months after delivery. |
| Number of Participants Attending Any Postpartum Visit | 12 weeks after delivery | 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. |
| Number of Participants for Whom Postpartum Diabetes Screening Was Ordered | 12 weeks after delivery | Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records. |
| Number of Participants for Whom Postpartum Diabetes Screening Was Performed | 12 weeks after delivery | Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records. |
| Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered | 12 weeks after delivery | 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. |
| Number of Participants With Diabetes for Whom Postpartum Screening Was Performed | 12 weeks after delivery | 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. |
| Number of Participants Receiving Postpartum Hypertension Screening | 12 weeks after delivery | Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records. |
| Number of Participants With Hypertension Receiving Postpartum Hypertension Screening | 12 weeks after delivery | 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. |
| Number of Participants Using Contraception | 12 weeks after delivery, 14 months after delivery | The number of participants using contraception is evaluated via patient self-report survey. |
| Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score | 12 weeks after delivery, 14 months after delivery | 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. |
| Satisfaction With Postpartum Care | 12 weeks after delivery | 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. |
| Satisfaction With Provider at Postpartum Care Visit | 12 weeks after delivery | 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. |
| Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | 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. |
| Number of Participants Using Medication | 12 weeks after delivery, 14 months after delivery | The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction. |
| Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnne Dunlop, MD, MPH
Emory University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 159 |
| 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. | 161 |
| Total | 320 |
Baseline characteristics
| Characteristic | Standard of Care | Enhanced Postpartum Care System | Total |
|---|---|---|---|
| Age, Customized 18-24 | 37 Participants | 42 Participants | 79 Participants |
| Age, Customized 25-34 | 78 Participants | 81 Participants | 159 Participants |
| Age, Customized 35-45 | 46 Participants | 36 Participants | 82 Participants |
| Documented diagnoses Chronic hypertension | 70 Participants | 70 Participants | 140 Participants |
| Documented diagnoses Diabetes mellitus | 21 Participants | 18 Participants | 39 Participants |
| Documented diagnoses Gestational diabetes | 24 Participants | 18 Participants | 42 Participants |
| Documented diagnoses Hypertensive disorders of pregnancy | 8 Participants | 6 Participants | 14 Participants |
| Documented diagnoses Pre-pregnancy obesity | 70 Participants | 79 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 23 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 136 Participants | 274 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age at study enrollment 20-27 weeks | 97 Participants | 98 Participants | 195 Participants |
| Gestational age at study enrollment 28-34 weeks | 64 Participants | 61 Participants | 125 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 131 Participants | 133 Participants | 264 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 23 Participants | 47 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 161 Participants | 159 Participants | 320 Participants |
| Sex: Female, Male Female | 161 Participants | 159 Participants | 320 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of health insurance at delivery Medicaid/Medicare | 132 Participants | 119 Participants | 251 Participants |
| Type of health insurance at delivery Private insurance | 27 Participants | 35 Participants | 62 Participants |
| Type of health insurance at delivery Self-pay | 1 Participants | 1 Participants | 2 Participants |
| Type of health insurance at delivery Unknown | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 0 / 161 |
| other Total, other adverse events | 39 / 159 | 27 / 161 |
| serious Total, serious adverse events | 6 / 159 | 10 / 161 |
Outcome results
Primary
Number of Participants Attending a Comprehensive Postpartum Visit
The postpartum visit occurs between 4 and 12 weeks after delivery and meets specific, 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants Attending a Comprehensive Postpartum Visit | 84 Participants |
| Standard of Care | Number of Participants Attending a Comprehensive Postpartum Visit | 89 Participants |
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.
Time frame: 12 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants Attending Any Postpartum Visit | 109 Participants |
| Standard of Care | Number of Participants Attending Any Postpartum Visit | 116 Participants |
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.
Time frame: 12 weeks after delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Number of Participants for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening ordered | 18 Participants |
| Enhanced Postpartum Care System | Number of Participants for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening not ordered | 141 Participants |
| Standard of Care | Number of Participants for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening ordered | 26 Participants |
| Standard of Care | Number of Participants for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening not ordered | 135 Participants |
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.
Time frame: 12 weeks after delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Number of Participants for Whom Postpartum Diabetes Screening Was Performed | Postpartum diabetes screening completed | 9 Participants |
| Enhanced Postpartum Care System | Number of Participants for Whom Postpartum Diabetes Screening Was Performed | Postpartum diabetes screening not completed | 150 Participants |
| Standard of Care | Number of Participants for Whom Postpartum Diabetes Screening Was Performed | Postpartum diabetes screening completed | 14 Participants |
| Standard of Care | Number of Participants for Whom Postpartum Diabetes Screening Was Performed | Postpartum diabetes screening not completed | 147 Participants |
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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Poor | 8 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Excellent | 47 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Very Good | 18 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Good | 43 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Fair | 23 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Declined | 1 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Poor | 5 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Missing response/refused to answer | 4 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Excellent | 49 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Very Good | 21 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Good | 26 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Fair | 28 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Declined | 6 Participants |
| Enhanced Postpartum Care System | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Missing response/refused to answer | 3 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Good | 29 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Poor | 9 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Missing response/refused to answer | 7 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Excellent | 50 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Declined | 3 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Very Good | 23 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Excellent | 53 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Good | 32 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Fair | 24 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Fair | 24 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Very Good | 22 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Declined | 2 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Mental health since delivery | Missing response/refused to answer | 1 Participants |
| Standard of Care | Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery | Physical Health Since Delivery | Poor | 3 Participants |
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 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: 14 months after delivery
Secondary
Number of Participants Readmitted to the Hospital at 12 Weeks After Delivery
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants Readmitted to the Hospital at 12 Weeks After Delivery | 6 Participants |
| Standard of Care | Number of Participants Readmitted to the Hospital at 12 Weeks After Delivery | 9 Participants |
Secondary
Number of Participants Readmitted to the Hospital at 14 Months After Delivery
The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
Time frame: 14 months 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.
Time frame: 12 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants Receiving Postpartum Hypertension Screening | 80 Participants |
| Standard of Care | Number of Participants Receiving Postpartum Hypertension Screening | 81 Participants |
Secondary
Number of Participants Using Contraception 12 Weeks After Delivery
The number of participants using contraception is evaluated via patient self-report survey.
Time frame: 12 weeks after delivery
Population: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants Using Contraception 12 Weeks After Delivery | 119 Participants |
| Standard of Care | Number of Participants Using Contraception 12 Weeks After Delivery | 117 Participants |
Secondary
Number of Participants Using Contraception 14 Months After Delivery
The number of participants using contraception is evaluated via patient self-report survey.
Time frame: 14 months after delivery
Secondary
Number of Participants Using Medication 12 Weeks After Delivery
The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction.
Time frame: 12 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants Using Medication 12 Weeks After Delivery | 21 Participants |
| Standard of Care | Number of Participants Using Medication 12 Weeks After Delivery | 29 Participants |
Secondary
Number of Participants Using Medication 14 Months After Delivery
The number of participants using prescription medication for chronic conditions will be evaluated via medical record abstraction.
Time frame: 14 months after delivery
Secondary
Number of Participants Using Primary Care
The number of participants planning to attend, or have already attended, a visit with a primary care provider will be evaluated via medical record abstraction 14 months after delivery.
Time frame: 14 months after delivery
Secondary
Number of Participants Using Specialty Care
The number of participants planning to attend, or having already attended, a visit with a specialty health care will be evaluated via medical record abstraction 14 months after delivery.
Time frame: 14 months after delivery
Secondary
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery
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
Population: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery | EPDS score of 13 or higher | 37 Participants |
| Enhanced Postpartum Care System | Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery | EPDS score of less than 13 | 88 Participants |
| Enhanced Postpartum Care System | Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery | Refused to answer/missing response | 16 Participants |
| Standard of Care | Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery | EPDS score of 13 or higher | 26 Participants |
| Standard of Care | Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery | EPDS score of less than 13 | 92 Participants |
| Standard of Care | Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery | Refused to answer/missing response | 23 Participants |
Secondary
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 14 Months After Delivery
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: 14 months 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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants diagnosed with gestational diabetes or diabetes mellitus.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening ordered | 14 Participants |
| Enhanced Postpartum Care System | Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening not ordered | 22 Participants |
| Standard of Care | Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening ordered | 19 Participants |
| Standard of Care | Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered | Postpartum diabetes screening not ordered | 26 Participants |
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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants diagnosed with gestational diabetes or diabetes mellitus.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Number of Participants With Diabetes for Whom Postpartum Screening Was Performed | Postpartum diabetes screening completed | 8 Participants |
| Enhanced Postpartum Care System | Number of Participants With Diabetes for Whom Postpartum Screening Was Performed | Postpartum diabetes screening not completed | 28 Participants |
| Standard of Care | Number of Participants With Diabetes for Whom Postpartum Screening Was Performed | Postpartum diabetes screening completed | 11 Participants |
| Standard of Care | Number of Participants With Diabetes for Whom Postpartum Screening Was Performed | Postpartum diabetes screening not completed | 34 Participants |
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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants diagnosed with hypertensive disorders of pregnancy or chronic hypertension.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants With Hypertension Receiving Postpartum Hypertension Screening | 45 Participants |
| Standard of Care | Number of Participants With Hypertension Receiving Postpartum Hypertension Screening | 48 Participants |
Secondary
Number of Participants With Ongoing Pregnancy Complications at 12 Weeks After Delivery
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Postpartum Care System | Number of Participants With Ongoing Pregnancy Complications at 12 Weeks After Delivery | 2 Participants |
| Standard of Care | Number of Participants With Ongoing Pregnancy Complications at 12 Weeks After Delivery | 3 Participants |
Secondary
Number of Participants With Ongoing Pregnancy Complications at 14 Months After Delivery
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: 14 months after delivery
Secondary
Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery
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
Population: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery | Low risk | 55 Participants |
| Enhanced Postpartum Care System | Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery | Average or high risk | 26 Participants |
| Enhanced Postpartum Care System | Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery | Don't know/refused to answer/missing response | 60 Participants |
| Standard of Care | Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery | Low risk | 58 Participants |
| Standard of Care | Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery | Average or high risk | 31 Participants |
| Standard of Care | Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery | Don't know/refused to answer/missing response | 52 Participants |
Secondary
Perceived Risk of Cardiovascular Disease at 14 Month After Delivery
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: 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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Perceived Risk of Severe Maternal Morbidity (SMM) | Perceived risk value - low risk | 35 Participants |
| Enhanced Postpartum Care System | Perceived Risk of Severe Maternal Morbidity (SMM) | Perceived risk value - average or high risk | 66 Participants |
| Enhanced Postpartum Care System | Perceived Risk of Severe Maternal Morbidity (SMM) | Don't know/refused to answer/missing response | 40 Participants |
| Standard of Care | Perceived Risk of Severe Maternal Morbidity (SMM) | Perceived risk value - low risk | 34 Participants |
| Standard of Care | Perceived Risk of Severe Maternal Morbidity (SMM) | Perceived risk value - average or high risk | 76 Participants |
| Standard of Care | Perceived Risk of Severe Maternal Morbidity (SMM) | Don't know/refused to answer/missing response | 31 Participants |
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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants who reported completing a postpartum visit. Some participants did not respond to every survey item.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Postpartum Care System | Satisfaction With Postpartum Care | Satisfied with wait time | 88 Participants |
| Enhanced Postpartum Care System | Satisfaction With Postpartum Care | Satisfied with amount of time with healthcare providers | 90 Participants |
| Enhanced Postpartum Care System | Satisfaction With Postpartum Care | Satisfied with advice given | 91 Participants |
| Enhanced Postpartum Care System | Satisfaction With Postpartum Care | Satisfied with respect shown to each individual as a person | 93 Participants |
| Standard of Care | Satisfaction With Postpartum Care | Satisfied with respect shown to each individual as a person | 87 Participants |
| Standard of Care | Satisfaction With Postpartum Care | Satisfied with wait time | 81 Participants |
| Standard of Care | Satisfaction With Postpartum Care | Satisfied with advice given | 82 Participants |
| Standard of Care | Satisfaction With Postpartum Care | Satisfied with amount of time with healthcare providers | 79 Participants |
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.
Time frame: 12 weeks after delivery
Population: This analysis includes participants who reported completing a postpartum visit. Some participants did not respond to every survey item.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Postpartum Care System | Satisfaction With Provider at Postpartum Care Visit | Respected me as a person | 4.7 units on a scale | Standard Deviation 0.6 |
| Enhanced Postpartum Care System | Satisfaction With Provider at Postpartum Care Visit | Letting me say what mattered to me about my health | 4.7 units on a scale | Standard Deviation 0.6 |
| Enhanced Postpartum Care System | Satisfaction With Provider at Postpartum Care Visit | Taking my preferences seriously | 4.7 units on a scale | Standard Deviation 0.7 |
| Enhanced Postpartum Care System | Satisfaction With Provider at Postpartum Care Visit | Giving me enough information to make the best decisions about my health | 4.7 units on a scale | Standard Deviation 0.6 |
| Standard of Care | Satisfaction With Provider at Postpartum Care Visit | Giving me enough information to make the best decisions about my health | 4.6 units on a scale | Standard Deviation 0.9 |
| Standard of Care | Satisfaction With Provider at Postpartum Care Visit | Respected me as a person | 4.7 units on a scale | Standard Deviation 0.5 |
| Standard of Care | Satisfaction With Provider at Postpartum Care Visit | Taking my preferences seriously | 4.6 units on a scale | Standard Deviation 0.8 |
| Standard of Care | Satisfaction With Provider at Postpartum Care Visit | Letting me say what mattered to me about my health | 4.6 units on a scale | Standard Deviation 0.8 |