An interventional study of Care Box in Prenatal Follow Up Care, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Supportive care
The purpose of this research study is to understand if receipt of extra prenatal resources from the ED visit improves i) the patient's ability to engage in prenatal services after the ED visit, and ii) how it impacts the patient's pregnancy knowledge and confidence. If participant's consent to this study, the participants will receive standard of care and additionally be randomized, like flipping a coin, to receive either i) extra prenatal care resources in the form of a 'care box' during this ED visit, or ii) the extra prenatal care resources in the form of a 'care box" two weeks from today. All participants will also receive a follow-up survey asking about the patient's engagement in prenatal services following ED visit, perceptions of pregnancy knowledge and confidence, the usefulness of the resources received, and what additional resources might have been helpful during the early stages of pregnancy. Participation in this study will not require any additional clinic or hospital visits. The total time involved is approximately 20 minutes during the initial ED visit and less than 20 minutes to complete the follow-up survey. Investigators hope to enroll a total of 50 participants in this study.
University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Providing care box during the ED visit
Behavioral: Care Box
Will be provided care box at a future date
Behavioral: Care Box
The resources in the care box include a water bottle, pocket calendar (monthly planner) and pen, recorder in the shape of a heart, bus pass, mini stuffed animal, and a welcome insert (includes descriptions for the items and a QR code with additional resources) additionally, the QR code will be on the inside of the box's top as well as on the insert.
Change in number of OBGYN follow up appointments as measured by medical record review
Time frame: 1 week, 1 month, 3 months, 6 months, 9 months
Number of participants with a pregnancy outcome of 1 as measured by medical record review
Pregnancy outcome of 1 is defined as full term live birth with healthy weight (\> 2500g)
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 2 as measured by medical record review
Pregnancy outcome of 2 is defined as full term live birth with low birth weight (\< 2500g)
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 3 as measured by medical record review
Pregnancy outcome of 3 is defined as pre-term live birth (\< 37 weeks)
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 4 as measured by medical record review
Pregnancy outcome of 4 is defined as miscarriage/spontaneous abortion
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 5 as measured by medical record review
Pregnancy outcome of 5 is defined as stillbirth (fetal death at/after 28 weeks)
Time frame: Up to 9 months
Number of participants who affirmed the care box supported the pregnancy as measured by patient survey
Time frame: Up to 1 week
Plan to share: No
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University Hospitals Cleveland Medical Center