Trial Outcomes & Findings for Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk (NCT NCT06276647)

Last Updated: 2026-04-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

220 participants

Primary outcome timeframe

1-30 days postpartum

Results posted on

2026-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Standard Postpartum Care These patients will receive Standard postpartum care.
Overall Study STARTED	110	110
Overall Study COMPLETED	110	110
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Education Pamphlet and Partner Sheet n=110 Participants 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 n=110 Participants These patients will receive Standard postpartum care.	Total n=220 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=527 Participants	110 Participants n=527 Participants	220 Participants n=1054 Participants
Age, Categorical >=65 years	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Sex: Female, Male Female	110 Participants n=527 Participants	110 Participants n=527 Participants	220 Participants n=1054 Participants
Sex: Female, Male Male	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	95 Participants n=527 Participants	97 Participants n=527 Participants	192 Participants n=1054 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	1 Participants n=527 Participants	4 Participants n=527 Participants	5 Participants n=1054 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native American	1 Participants n=527 Participants	0 Participants n=527 Participants	1 Participants n=1054 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=527 Participants	4 Participants n=527 Participants	4 Participants n=1054 Participants
Race/Ethnicity, Customized Race/Ethnicity · Missing	13 Participants n=527 Participants	5 Participants n=527 Participants	18 Participants n=1054 Participants
Household Income <$15,000	29 Participants n=527 Participants	32 Participants n=527 Participants	61 Participants n=1054 Participants
Household Income $15,000-$45,000	26 Participants n=527 Participants	24 Participants n=527 Participants	50 Participants n=1054 Participants
Household Income $45,000-$75,000	15 Participants n=527 Participants	21 Participants n=527 Participants	36 Participants n=1054 Participants
Household Income $75,000+	12 Participants n=527 Participants	4 Participants n=527 Participants	16 Participants n=1054 Participants
Household Income Missing	28 Participants n=527 Participants	29 Participants n=527 Participants	57 Participants n=1054 Participants
Age, Continuous	30.0 years STANDARD_DEVIATION 6.3 • n=527 Participants	28.7 years STANDARD_DEVIATION 6.4 • n=527 Participants	29.4 years STANDARD_DEVIATION 6.4 • n=1054 Participants
Type of Housing Own	59 Participants n=527 Participants	66 Participants n=527 Participants	125 Participants n=1054 Participants
Type of Housing Rent	19 Participants n=527 Participants	14 Participants n=527 Participants	33 Participants n=1054 Participants
Type of Housing No Housing	12 Participants n=527 Participants	20 Participants n=527 Participants	32 Participants n=1054 Participants
Type of Housing Prefer Not to Say	11 Participants n=527 Participants	5 Participants n=527 Participants	16 Participants n=1054 Participants
Type of Housing Missing	9 Participants n=527 Participants	5 Participants n=527 Participants	14 Participants n=1054 Participants
Martial Status Single	51 Participants n=527 Participants	58 Participants n=527 Participants	109 Participants n=1054 Participants
Martial Status Married	38 Participants n=527 Participants	34 Participants n=527 Participants	72 Participants n=1054 Participants
Martial Status Other	13 Participants n=527 Participants	10 Participants n=527 Participants	23 Participants n=1054 Participants
Martial Status Missing	8 Participants n=527 Participants	8 Participants n=527 Participants	16 Participants n=1054 Participants
Education Less than HS	8 Participants n=527 Participants	7 Participants n=527 Participants	15 Participants n=1054 Participants
Education HS/GED	46 Participants n=527 Participants	52 Participants n=527 Participants	98 Participants n=1054 Participants
Education Some college- Bachelor	35 Participants n=527 Participants	37 Participants n=527 Participants	72 Participants n=1054 Participants
Education Graduate	10 Participants n=527 Participants	9 Participants n=527 Participants	19 Participants n=1054 Participants
Education Other	1 Participants n=527 Participants	0 Participants n=527 Participants	1 Participants n=1054 Participants
Education Missing	10 Participants n=527 Participants	5 Participants n=527 Participants	15 Participants n=1054 Participants

PRIMARY outcome

Timeframe: 1-30 days postpartum

Outcome measures

Outcome measures
Measure	Standard Postpartum Care n=18 Visits These patients will receive Standard postpartum care.	Intervention Group n=21 Visits Standard postpartum care in addition to the intervention. 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 (see patient navigator communication schedule).
Emergency Department (ED) Visits and Readmissions	18 Postpartum Hospital Use	21 Postpartum Hospital Use

SECONDARY outcome

Timeframe: 1-30 days postpartum

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.

Outcome measures

Outcome measures
Measure	Standard Postpartum Care n=110 Participants These patients will receive Standard postpartum care.	Intervention Group n=110 Participants Standard postpartum care in addition to the intervention. 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 (see patient navigator communication schedule).
Ability to Obtain Needed Services	48 Participants	42 Participants

SECONDARY outcome

Timeframe: 1 day-6 months postpartum

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

Outcome measures

Outcome measures
Measure	Standard Postpartum Care n=110 Participants These patients will receive Standard postpartum care.	Intervention Group n=110 Participants Standard postpartum care in addition to the intervention. 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 (see patient navigator communication schedule).
Depressive Symptoms	10 Participants	5 Participants

Adverse Events

Patient Education Pamphlet and Partner Sheet

Serious events: 2 serious events

Other events: 33 other events

Deaths: 2 deaths

Standard Postpartum Care

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patient Education Pamphlet and Partner Sheet n=110 participants at risk 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 n=110 participants at risk These patients will receive Standard postpartum care.
Pregnancy, puerperium and perinatal conditions Death	1.8% 2/110 • 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.	0.00% 0/110 • 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.

Other adverse events

Other adverse events
Measure	Patient Education Pamphlet and Partner Sheet n=110 participants at risk 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 n=110 participants at risk These patients will receive Standard postpartum care.
Pregnancy, puerperium and perinatal conditions EPDS >=13 OR Suicidal Ideation	30.0% 33/110 • 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.	35.5% 39/110 • 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.

Additional Information

Angelina Malenda

University of Pennsylvania

Phone: 5514823655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place