Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MD016029 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Columbia University | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
The goal of this educational clinical trial is to identify high-need women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for these high-need patients.
The main question[s] it aims to answer are:
Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Education Pamphlet and Partner Sheet | Experimental | The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources. |
|
| Standard Postpartum Care | No Intervention | These patients will receive Standard postpartum care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOME | Behavioral | The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum patients. The patient navigator will explain this pamphlet at postpartum discharge, then will follow-up with the patients up to 30 days in the postpartum period. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department (ED) Visits and Readmissions | To obtain data for the primary outcome of postpartum morbidity and mortality as measured by Emergency Department (ED) visits and hospital readmissions in the 30-day post discharge period. Investigators will use chart reviews to obtain this ED/Readmission information. | 1-30 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Obtain Needed Services | To detect the ability of participants to "obtain needed services" in the 30-day post discharge period as one of the main pathways of unnecessary ED visits. Investigators ask patients three weeks postpartum: "Please rate your ability to do the following on a scale of never-sometimes-often-always: Your ability to get through to the doctor's or midwife's office by phone; Your ability to speak to your provider by phone; Your ability to see your provider if you felt you needed to." We score never as 1 and always as 4. If access score is greater than or equal to 11, they are considered having high provider access. Percentage of patients reflects those who had high provider access. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patient Education Pamphlet and Partner Sheet | The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources. |
| FG001 | Standard Postpartum Care | These patients will receive Standard postpartum care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patient Education Pamphlet and Partner Sheet | The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Emergency Department (ED) Visits and Readmissions | To obtain data for the primary outcome of postpartum morbidity and mortality as measured by Emergency Department (ED) visits and hospital readmissions in the 30-day post discharge period. Investigators will use chart reviews to obtain this ED/Readmission information. | Posted | Feb 2026 | Number | Postpartum Hospital Use | 1-30 days postpartum | Visits | Visits |
|
From enrollment until end of follow up, up to 6 months
Serious adverse events reporting follow the clinicaltrials.gov definition. This protocol was deemed minimal risk, therefore, the only non-serious adverse events captured were related to high EPDS and/or suicidal ideation.
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 | Patient Education Pamphlet and Partner Sheet | The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EPDS >=13 OR Suicidal Ideation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelina Malenda | University of Pennsylvania | 5514823655 | angelina.malenda@pennmedicine.upenn.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 | Feb 2, 2024 | Jan 6, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1-30 days postpartum |
| Depressive Symptoms | The number of participants in the trial who scored an 11 or higher on the Edinburgh Postnatal Depression Scale (EPDS: a ten-item scale that measures minor or major depression and self-harm through 4-point Likert scale responses. Scores can range from 0-30. Higher scores indicate worse outcomes). The score was ascertained from a Redcap survey including EPDS. For more information see Cox et al. 1987 | 1 day-6 months postpartum |
| BG001 | Standard Postpartum Care | These patients will receive Standard postpartum care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Household Income | Count of Participants | Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Type of Housing | Housing situation | Count of Participants | Participants |
|
| Martial Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
|
|
| Secondary | Ability to Obtain Needed Services | To detect the ability of participants to "obtain needed services" in the 30-day post discharge period as one of the main pathways of unnecessary ED visits. Investigators ask patients three weeks postpartum: "Please rate your ability to do the following on a scale of never-sometimes-often-always: Your ability to get through to the doctor's or midwife's office by phone; Your ability to speak to your provider by phone; Your ability to see your provider if you felt you needed to." We score never as 1 and always as 4. If access score is greater than or equal to 11, they are considered having high provider access. Percentage of patients reflects those who had high provider access. | Posted | Count of Participants | Participants | 1-30 days postpartum |
|
|
|
| Secondary | Depressive Symptoms | The number of participants in the trial who scored an 11 or higher on the Edinburgh Postnatal Depression Scale (EPDS: a ten-item scale that measures minor or major depression and self-harm through 4-point Likert scale responses. Scores can range from 0-30. Higher scores indicate worse outcomes). The score was ascertained from a Redcap survey including EPDS. For more information see Cox et al. 1987 | Posted | Count of Participants | Participants | 1 day-6 months postpartum |
|
|
|
| 2 |
| 110 |
| 2 |
| 110 |
| 33 |
| 110 |
| EG001 | Standard Postpartum Care | These patients will receive Standard postpartum care. | 0 | 110 | 0 | 110 | 39 | 110 |
Not provided
Not provided
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |