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| Name | Class |
|---|---|
| Sarah Osmundson, MD, MS | UNKNOWN |
| Alex Phelps, MD | UNKNOWN |
| Julia Phillippi, PhD, CNM | UNKNOWN |
| Soha Patel, MD, MSPH |
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Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
Hypertension complicates 10% of pregnancies in the U.S., directly accounting for 7% of pregnancy-related deaths and 38% of severe maternal morbidity. Hypertensive disorders of pregnancy (HDP) include chronic hypertension, gestational hypertension, preeclampsia, hemolysis-elevated-liver enzymes-low platelets (HELLP), and eclampsia, and occur 2.5 times more frequently among Black compared to non-Black patients. The weeks after delivery are crucial for maternal health, severe maternal morbidity, and hypertension-associated morbidity. Half of all pregnancy-related deaths occur in this time and Black patients are impacted disproportionally by these morbidities including pulmonary edema, stroke, and renal failure.
The American College of Obstetricians and Gynecologists (ACOG) recently redefined postpartum care to encompass 12 months after birth and stressed the importance of connecting postpartum patients to primary care clinicians to manage chronic conditions. This handoff is critical as 50% of patients with HDP develop chronic hypertension, and patients affected by HDP have twice the risk of later cardiovascular-related death. Recently, Tennessee expanded Medicaid coverage to 12 months postpartum. Given that most obstetric clinicians do not provide comprehensive primary care, investigators urgently need models for bridging gaps in care after pregnancy. While interventions such as telemedicine and peer navigation demonstrate promise to improve patient engagement in care and reduce postpartum racial disparities,15-18 no randomized trials address system-level initiatives to improve postpartum care for patients with HDP.
Another area of active investigation relates to establishing appropriate blood pressure targets for patients in and around the time of pregnancy. Recent findings from the Chronic Hypertension and Pregnancy Trial suggest that stricter control of antepartum blood pressure is beneficial in reducing the incidence of a composite adverse perinatal outcome which included preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks of gestation, placental abruption, and fetal or neonatal death. This trial has been practice-changing, lowering the historic antepartum blood pressure target from 160/110mmHg (millimeter of mercury) to less than 140/90mmHg. However, this trial did not contemplate the management of maternal blood pressure in the postpartum period. ACOG presently endorses a postpartum goal of less than 150/100mmHg which, notably, is higher than the newly established antepartum goal. Furthermore, the blood pressure target set for non-pregnant adults by the American College of Cardiology and American Heart Association is even lower, at less than 120/80mmHg to minimize the cardiovascular disease risk associated with chronic hypertension.
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) Standard BP Control, Clinician Monitoring | Active Comparator | Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. |
|
| B) Tight BP Control, Clinician Monitoring | Active Comparator | Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. |
|
| C) Standard BP Control, Care Navigation | Active Comparator | Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Pressure Control Targets | Other | This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Recorded Blood Pressure Values in Office | Proportion of participants with blood pressure values recorded in the office | 7-10 days post delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Recorded Blood Pressure Values, Any Reporting | Proportion of participants with blood pressure values recorded through any means | 7-10 days post delivery |
| Systolic Blood Pressure, 7-10 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Felt That They Were Treated With Respect | Proportion of participants who responded "good", "very good", or "excellent" to the prompt "My health care team treated me with respect" | 2 weeks post delivery |
| Anxiety |
Inclusion Criteria
1. Not able or willing to receive electronic surveys 2. Deemed inappropriate for study enrollment by the bedside nurse 3. Non-English speaking 4. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)
Women who have recently given birth. The aim of this study evaluate post-partum hypertension care.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Osmundson, MD | Associate Professor Maternal-Fetal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A) Standard BP Control, Clinician Monitoring | Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| FG001 | B) Tight BP Control, Clinician Monitoring | Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| FG002 | C) Standard BP Control, Care Navigation | Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| FG003 | D) Tight BP Control, Care Navigation | Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Median (Interquartile Range)
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| ID | Title | Description |
|---|---|---|
| BG000 | A) Standard BP Control, Clinician Monitoring | Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Continuous age in years |
| 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 | Proportion of Participants With Recorded Blood Pressure Values in Office | Proportion of participants with blood pressure values recorded in the office | Posted | Count of Participants | Participants | 7-10 days post delivery |
|
Through study completion, an average of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A) Standard BP Control, Clinician Monitoring | Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
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There are important limitations to our study. First, the randomized controlled trial design increases internal validity of our findings but can also decrease external validity. Forty-eight percent of eligible patients did not enroll, raising concerns for how our interventions would perform outside of a research setting. In addition, we were unable to enroll non-English speaking participants, who are an important population to consider especially for larger implementation efforts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Osmundson, MD, MS | Vanderbilt University Medical Center | 6158752231 | sarah.osmundson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 4, 2023 | Aug 5, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
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| UNKNOWN |
| Etoi Garrison, MD, PhD | UNKNOWN |
| Kathryn Lindley, MD | UNKNOWN |
A factorial study design will be used where participants will be randomized in a 1:1:1:1 ratio to two intervention types (blood pressure target, hypertension care model) or four total interventions.
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Research personnel assessing outcomes will be masked to the intervention
| D) Tight BP Control, Care Navigation | Active Comparator | Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. |
|
| Hypertension Management | Other | This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
|
Mean difference in systolic blood pressure from baseline, 7-10 days
| 7-10 days post delivery |
| Diastolic Blood Pressure | Mean difference in diastolic blood pressure from baseline, 7-10 days | 7-10 days post delivery |
| Systolic Blood Pressure, 4-6 Weeks | Mean systolic blood pressure, 4-6 weeks | 4-6 weeks post delivery |
| Diastolic Blood Pressure, 4-6 Weeks | Mean diastolic blood pressure, 4-6 weeks | 4-6 weeks post delivery |
| Initiated New Medications | Initiated new antihypertensive medications by 7-10 days postpartum | 7-10 days |
| Sustained Severe Hypertension, 7-10 Days | Proportion of participants with two blood pressures >=160/100 at least 15 minutes apart | 7-10 days postpartum |
| Unplanned Visits | Proportion of patients with obstetric triage visits, emergency department visits, or hospital readmission | 7-10 days |
| Postpartum Visit Attendance | Proportion of patients with postpartum visit attendance | 3-6 weeks post delivery |
| Primary Care Visit Attendance | Proportion of patients with primary care visit attendance | 3 months post delivery |
Measure of the mean T-score. The T-score rescales the raw score into a standardized T-score with a range of 0-100 where the population mean is 50 and the standard deviation (SD) of 10. In this range 0 is no anxiety and 100 is high anxiety.
| 2 weeks post delivery |
| Instrumental Support | Measure of the mean T-score. The T-score rescales the raw score into a standardized T-score with a range of 0-100 where the population mean is 50 and the standard deviation (SD) of 10. In this range 0 is no support and 100 is high support. | 2 weeks post delivery |
| Mothers on Respect Index Score | The Mothers on Respect (MOR) index was developed to assess the nature of patient-provider interactions and their impact on a person's sense of respect during maternity care. The MOR index is a patient-informed quality and safety indicator that can be applied across jurisdictions to assess the nature of provider-patient relationships, and access to person-centered care. Responses are summed to provide a total score with a range of 18-84 with higher scores indicating more respectful care. A score of 50-66 indicates moderate respect and 67-84 indicates high respect. | 6 weeks post delivery |
| BG001 | B) Tight BP Control, Clinician Monitoring | Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| BG002 | C) Standard BP Control, Care Navigation | Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| BG003 | D) Tight BP Control, Care Navigation | Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| BG004 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Percentage male and female | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | B) Tight BP Control, Clinician Monitoring | Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| OG002 | C) Standard BP Control, Care Navigation | Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
| OG003 | D) Tight BP Control, Care Navigation | Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. |
|
|
| Secondary | Proportion of Participants With Recorded Blood Pressure Values, Any Reporting | Proportion of participants with blood pressure values recorded through any means | Posted | Number | participants | 7-10 days post delivery |
|
|
|
| Secondary | Systolic Blood Pressure, 7-10 Days | Mean difference in systolic blood pressure from baseline, 7-10 days | Posted | Median | Inter-Quartile Range | mmHg | 7-10 days post delivery |
|
|
|
| Secondary | Diastolic Blood Pressure | Mean difference in diastolic blood pressure from baseline, 7-10 days | Participants | Posted | Median | Inter-Quartile Range | mmHg | 7-10 days post delivery |
|
|
|
| Secondary | Systolic Blood Pressure, 4-6 Weeks | Mean systolic blood pressure, 4-6 weeks | Some patient drop out at 6 weeks of follow up | Posted | Jan 2026 | Mean | Standard Deviation | mmHg | 4-6 weeks post delivery |
|
|
|
| Secondary | Diastolic Blood Pressure, 4-6 Weeks | Mean diastolic blood pressure, 4-6 weeks | Posted | Jan 2026 | Mean | Standard Deviation | mmHg | 4-6 weeks post delivery |
|
|
|
| Secondary | Initiated New Medications | Initiated new antihypertensive medications by 7-10 days postpartum | Participants | Posted | Count of Participants | Participants | 7-10 days |
|
|
|
| Secondary | Sustained Severe Hypertension, 7-10 Days | Proportion of participants with two blood pressures >=160/100 at least 15 minutes apart | Participants | Posted | Count of Participants | Participants | 7-10 days postpartum |
|
|
|
| Secondary | Unplanned Visits | Proportion of patients with obstetric triage visits, emergency department visits, or hospital readmission | Participants | Posted | Count of Participants | Participants | 7-10 days |
|
|
|
| Secondary | Postpartum Visit Attendance | Proportion of patients with postpartum visit attendance | Posted | Jan 2026 | Count of Participants | Participants | 3-6 weeks post delivery |
|
|
|
| Secondary | Primary Care Visit Attendance | Proportion of patients with primary care visit attendance | Posted | Jan 2026 | Count of Participants | Participants | 3 months post delivery |
|
|
|
| Other Pre-specified | Felt That They Were Treated With Respect | Proportion of participants who responded "good", "very good", or "excellent" to the prompt "My health care team treated me with respect" | Posted | Jan 2026 | Count of Participants | Participants | 2 weeks post delivery |
|
|
|
| Other Pre-specified | Anxiety | Measure of the mean T-score. The T-score rescales the raw score into a standardized T-score with a range of 0-100 where the population mean is 50 and the standard deviation (SD) of 10. In this range 0 is no anxiety and 100 is high anxiety. | Posted | Mean | Standard Deviation | T-score | 2 weeks post delivery |
|
|
|
| Other Pre-specified | Instrumental Support | Measure of the mean T-score. The T-score rescales the raw score into a standardized T-score with a range of 0-100 where the population mean is 50 and the standard deviation (SD) of 10. In this range 0 is no support and 100 is high support. | Not all participants completed this last survey | Posted | Mean | Standard Deviation | T-score | 2 weeks post delivery |
|
|
|
| Other Pre-specified | Mothers on Respect Index Score | The Mothers on Respect (MOR) index was developed to assess the nature of patient-provider interactions and their impact on a person's sense of respect during maternity care. The MOR index is a patient-informed quality and safety indicator that can be applied across jurisdictions to assess the nature of provider-patient relationships, and access to person-centered care. Responses are summed to provide a total score with a range of 18-84 with higher scores indicating more respectful care. A score of 50-66 indicates moderate respect and 67-84 indicates high respect. | Posted | Mean | Standard Deviation | MOR Score | 6 weeks post delivery |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | B) Tight BP Control, Clinician Monitoring | Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. | 0 | 82 | 0 | 82 | 0 | 82 |
| EG002 | C) Standard BP Control, Care Navigation | Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. | 0 | 83 | 0 | 83 | 0 | 83 |
| EG003 | D) Tight BP Control, Care Navigation | Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up. Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90 Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant. | 0 | 85 | 0 | 85 | 0 | 85 |
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| D002318 | Cardiovascular Diseases |