Prenatal Follow Up CareNCT07499648
Baby Steps to Care
A study testing Care Box in people with Prenatal Follow Up Care, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Follow Up Care
- What is being tested?
- Care Box
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Prisoners
- Non-Ohio residents
- Serious medical conditions (severe cardiovascular disease, infections, trauma) or critical illness requiring urgent hospitalization
- Nonpregnant persons including men
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University University Cleveland Medical Center
Cleveland, Ohio, 44106
Andie Moore, MS, (216) 286 - 7239, andie.moore@uhhospitals.org
About this study
Official title: 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.
- Conditions
- Prenatal Follow Up Care
- Being tested
- Care Box
- Keywords
- Emergency Department Visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care BoxBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Care Box - Now | Experimental | Providing care box during the ED visit Receives: Behavioral: Care Box |
| Care Box - Future | Active comparator | Will be provided care box at a future date Receives: Behavioral: Care Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of OBGYN follow up appointments as measured by medical record review
Measured: 1 week, 1 month, 3 months, 6 months, 9 months
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Up to 9 months
Number of participants who affirmed the care box supported the pregnancy as measured by patient survey
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start23 Apr 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Follow Up CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Faryar, MD, University Hospitals Cleveland Medical Center
- Investigators
- Kiran Faryar, MD, MPH, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499648
- Sponsor's protocol ID
- STUDY20251517
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby Steps to Care - Improving Access to Prenatal Care From the Emergency Department
- ClinicalTrials.gov ID
- NCT07499648
- Acronym / sponsor ID
- STUDY20251517
- Conditions
- Prenatal Follow Up Care
- Keywords
- Emergency Department Visit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Box - Now | Experimental | Behavioral: Care BoxProviding care box during the ED visit |
| Care Box - Future | Active comparator | Behavioral: Care BoxWill be provided care box at a future date |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Prisoners
- Non-Ohio residents
- Serious medical conditions (severe cardiovascular disease, infections, trauma) or critical illness requiring urgent hospitalization
- Nonpregnant persons including men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care BoxThe 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. | Behavioural | Care Box - Future, Care Box - Now |
Primary outcome
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
6 secondary outcomes
Number of participants with a pregnancy outcome of 1 as measured by medical record review
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 2 as measured by medical record review
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 3 as measured by medical record review
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 4 as measured by medical record review
Time frame: Up to 9 months
Number of participants with a pregnancy outcome of 5 as measured by medical record review
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Prenatal Follow Up Care
Recruiting
Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
Maternal Health Care, Hypertensive Disorder of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiran Faryar, MD, MPH principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Box in people with Prenatal Follow Up Care, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andie Moore, MS ((216) 286 - 7239, andie.moore@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.