Baby Steps to Care

Baby Steps to Care - Improving Access to Prenatal Care From the Emergency Department

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.

Study Overview

• Status: Recruiting
• Conditions: Prenatal Follow Up Care
• Intervention / Treatment: Behavioral: Care Box

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andie Moore, MS; Phone Number: (216) 286 - 7239; Email: andie.moore@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University University Cleveland Medical Center
      • Contact: Andie Moore, MS; Phone Number: (216) 286 - 7239; Email: andie.moore@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Care Box - Now; Providing care box during the ED visit	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.
Active Comparator: Care Box - Future; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in number of OBGYN follow up appointments as measured by medical record review	1 week, 1 month, 3 months, 6 months, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	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)	Up to 9 months
Number of participants who affirmed the care box supported the pregnancy as measured by patient survey		Up to 1 week

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Kiran Faryar, MD, MPH, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Emergency Department Visit
• Other Study ID Numbers: STUDY20251517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No