Skip to content

Baby Steps to Care

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07499648
Enrollment
50
Registered
2026-03-30
Start date
2026-04-23
Completion date
2027-01-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prenatal Follow Up Care

Keywords

Emergency Department Visit

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.

Interventions

BEHAVIORALCare 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.

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in number of OBGYN follow up appointments as measured by medical record review1 week, 1 month, 3 months, 6 months, 9 months

Secondary

MeasureTime frameDescription
Number of participants with a pregnancy outcome of 1 as measured by medical record reviewUp to 9 monthsPregnancy outcome of 1 is defined as full term live birth with healthy weight (\> 2500g)
Number of participants with a pregnancy outcome of 2 as measured by medical record reviewUp to 9 monthsPregnancy outcome of 2 is defined as full term live birth with low birth weight (\< 2500g)
Number of participants with a pregnancy outcome of 3 as measured by medical record reviewUp to 9 monthsPregnancy outcome of 3 is defined as pre-term live birth (\< 37 weeks)
Number of participants with a pregnancy outcome of 4 as measured by medical record reviewUp to 9 monthsPregnancy outcome of 4 is defined as miscarriage/spontaneous abortion
Number of participants with a pregnancy outcome of 5 as measured by medical record reviewUp to 9 monthsPregnancy outcome of 5 is defined as stillbirth (fetal death at/after 28 weeks)
Number of participants who affirmed the care box supported the pregnancy as measured by patient surveyUp to 1 week

Countries

United States

Contacts

CONTACTAndie Moore, MS
andie.moore@uhhospitals.org(216) 286 - 7239
PRINCIPAL_INVESTIGATORKiran Faryar, MD, MPH

University Hospitals Cleveland Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026