N/A
N=87
Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women
Pregnancy Related · Postpartum Sadness
Bottom Line
View on ClinicalTrials.gov: NCT04475718 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change From Baseline Resilience at 4 Weeks — 26.57; 28.29; 1.85 score on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fourth Trimester Mobile Tool (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Carelon Research
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Resilience at 4 Weeks |
26.57; 28.29; 1.85 | <.001 sig |
| SECONDARY Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS) |
8.90; 8.70; -0.24 | — |
| SECONDARY Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey |
3.67; 3.64; -0.02 | — |
| SECONDARY Change From Baseline Parent Anxiety at 4 Weeks |
41.44; 40.87; -0.82 | — |
| SECONDARY Change From COVID-19 and Mental Health Impacts at 4 Weeks |
29.34; 29.65; 0.03 | — |
Summary
The postpartum period is a critical time for both maternal and child health, and more than half of all maternal deaths occur postpartum, from one day to one year after birth. This poor outcome is linked to the racial and ethnic disparities that disproportionately effects low income and black women. To reduce the burden of the postpartum period for this population, the goal of this project is to develop an accessible, targeted online tool designed to address the needs of underserved women who are at greater risk for adverse postpartum outcomes by providing the appropriate tools, knowledge and skills to improve postpartum health.
Eligibility Criteria
Inclusion Criteria
- Age 18+;
- Self-reported annual household income less than $39,500 (at least 75% of participants - defined as "low income" household by the PEW Research Center);
- Racial/ethnic minority (at least 75% of participants must be non-white, with at least 50% identifying as Black/African American);
- Be a new or expectant mother - participants must be at least 28 weeks/6 months pregnant (3rd trimester), and up to 6 months post-birth (no more than 10% of participants will be currently pregnant, at least 90% will be postpartum).
- Able to comply with the terms of the study (available time commitment, have internet access; willing to comply with the specified focus groups and survey); and
- Able to read, write and speak English (all research and product development activities will be conducted in English due to budgetary constraints).
Exclusion Criteria
- Unable to comply with the Inclusion Criteria
- Did not have a live birth (for those who are post-birth)
- Self-reported major medical/health issue which would impact participants' health or ability to participate.
Data sourced from ClinicalTrials.gov (NCT04475718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.