Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Postpartum Sadness
  • Pregnancy Related
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Interviews will be conducted with 30 pregnant and postpartum women. From this research and other activities, the investigators will build a prototype program. Once the prototype is completed, the investigators will conduct a pre-test with 85 participants. The pre-test will capture key outcome measures (resilience, stress, anxiety, depression, fear, knowledge, and variables related to COVID-19) and other descriptive variables. All participants who complete the pre-test will be given access to the prototype mobile postpartum tool. Participants will be asked to actively engage with the tool for 4 weeks, during which time they will be able to provide real-time user experience feedback. At the end of the 4-week period, the investigators will conduct a post-test to measure change in outcomes. The investigators will also conduct follow up interviews with the original 30 participants.Masking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 21 years and 125 years
Gender
Only males

Description

In the United States, the postpartum period is a critical time for both maternal and child health, the mortality rate is the highest among other developed, high income countries and more than half of all maternal deaths occur postpartum, from one day to one year after birth. This poor outcome is lin...

In the United States, the postpartum period is a critical time for both maternal and child health, the mortality rate is the highest among other developed, high income countries 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 effect black women who are 3-4 times more likely to experience maternal mortality than white women. Recently, the American College of Obstetricians and Gynecologists recognized the deficiencies in postpartum care and coined the term the 'fourth trimester' to mark the time following the birth of the infant through the first 3-months postpartum, and updated its recommendations to address these challenges. With impacts to health outcomes and healthcare costs, there is a need to holistically bridge the gap for low-income and/or ethnically diverse groups of women to address the physical, cultural, and knowledge barriers to accessing quality postpartum care. To improve the rate at which underserved women are disproportionately affected by maternal mortality and morbidity, the investigators need to engage women leading into and specifically during the postpartum period to identity areas of need, and to provide tools which reduce barriers for women to get appropriate postpartum care. Technology offers innovative solutions to challenges around equal information access. Pregnant women often turn to the internet to find out more information about their health and their developing babies health. Yet, studies find that mothers are not finding sufficient resources to match their postpartum needs. To address this gap in care, this project aims to develop a mobile tool designed to increase accessibility to information and practical approaches for addressing the complex needs of women in this 'fourth trimester'. This tool will specifically focus on underserved women who are at greatest risk of adverse postpartum outcomes.

Tracking Information

NCT #
NCT04475718
Collaborators
  • Orange Square Design, Inc.
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Kristine Merz Orange Square Design, Inc. Principal Investigator: Lisa Marceau, MPH HealthCore-NERI