Recruiting

Care Box

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07499648

Conditions

Prenatal Follow Up Care

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Care Box

Study Details

Brief summary:

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.

Conditions

Prenatal Follow Up Care

Study ID

NCT07499648

Start date

Apr 23, 2026

Status verified date

Apr, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Found to be pregnant in the CMC Emergency Department through serum or urine pregnancy testing (hcg) or point of care (POC) urine testing
  • Ability to provide verbal consent to this study

Exclusion Criteria:

  • Prisoners
  • Non-Ohio residents
  • Serious medical conditions (severe cardiovascular disease, infections, trauma) or critical illness requiring urgent hospitalization
  • Nonpregnant persons including men

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Care Box - Now

Providing care box during the ED visit

active comparator: Care Box - Future

Will be provided care box at a future date

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University University Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Emergency Department Visit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-04-28.