50 Participants NeededMy employer runs this trial

Care Box for Prenatal Care

AM
Overseen ByAndie Moore, MS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how additional prenatal resources can assist pregnant individuals after an emergency department (ED) visit. Participants receive a "care box" (a package of prenatal resources) either during their ED visit or two weeks later. The study aims to determine if these resources improve engagement with prenatal services and increase pregnancy knowledge and confidence. This trial is ideal for those who have just discovered their pregnancy in the ED and can provide verbal consent. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance prenatal care for future patients.

What prior data suggests that the Care Box is safe for prenatal care?

Research has shown that care boxes, which typically contain essential supplies for mothers and babies, are generally safe. Studies have found that these boxes can improve the health of mothers and babies by providing necessary items like health supplies and baby care products. However, concerns exist about the safety of the boxes themselves, such as the risk of accidents if not used correctly.

Although this trial lacks specific data on problems directly linked to care boxes, they often support new parents. Following any instructions that come with the box is crucial for safe use. Overall, care boxes are considered helpful resources for supporting the health and well-being of both mothers and their babies.12345

Why are researchers excited about this trial?

Researchers are excited about the Care Box for prenatal care because it offers a unique approach to supporting expectant mothers during emergency department visits. Unlike traditional prenatal care, which often involves scheduled appointments and consultations, the Care Box provides immediate, tangible resources directly at the point of care. This method aims to address gaps in prenatal education and resource access by delivering essential items and information when mothers might need them the most. The hope is to enhance prenatal support and outcomes by making care more accessible and immediate.

What evidence suggests that the Care Box is effective for improving prenatal care engagement?

Research has shown that extra support during pregnancy can improve the health of both mothers and babies. For instance, attending group prenatal care can lower the chance of early birth by 58% and reduce the risk of having a baby with low birth weight by 63%. Women in these groups often feel more prepared for childbirth and express greater satisfaction with their prenatal care. These programs can also enhance communication between mothers and their partners. In this trial, participants will receive a Care Box either during their emergency department visit or at a later date. Although specific data on care boxes is limited, the overall trend of providing more prenatal support appears very promising.678910

Who Is on the Research Team?

KF

Kiran Faryar, MD, MPH

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to give verbal consent to join this study.
Found to be pregnant in the CMC Emergency Department through serum or urine pregnancy testing (hcg) or point of care (POC) urine testing

Exclusion Criteria

Non-Ohio residents
Prisoners
I am not pregnant.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Initial ED Visit

Participants receive standard care and are randomized to receive a care box either during the ED visit or two weeks later

20 minutes
1 visit (in-person)

Follow-up

Participants complete a follow-up survey about engagement in prenatal services and perceptions of pregnancy knowledge and confidence

Less than 20 minutes
1 survey (remote)

Outcome Monitoring

Participants' pregnancy outcomes are monitored through medical record review

Up to 9 months

What Are the Treatments Tested in This Trial?

Interventions

  • Care Box

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Care Box - NowExperimental Treatment1 Intervention
Group II: Care Box - FutureActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Citations

Effectiveness and evidence-based practices in maternal care ...

This systematic review aims to describe maternal care bundles on labour and birth, to assess their effectiveness on maternal outcomes and to ...

Group Prenatal Care

Studies appear to demonstrate high levels of patient satisfaction, obstetric outcomes equally efficacious as individual prenatal care, and improved outcomes for ...

Group Prenatal Care Compared With Traditional ... - PMC - NIH

Available data suggest that women who participate in group care have similar rates of preterm birth, NICU admission, and breastfeeding.

Birth Outcomes Improved Through Expect With Me Group ...

Mothers who received Expect With Me group prenatal care had a 58% lower risk of having a preterm birth, 63% lower risk of having an infant with low birthweight.

Group antenatal care positively transforms the care experience

They experienced less wait time, greater satisfaction with care (Estimate = 1.21, 99% CI = 0.07, 2.35), and had a higher mean number of ANC contacts (Estimate = ...

Baby Box Distributions: Public Health Benefit or Concern?

Because accidents or deaths related to use of the cardboard baby box would not be reported through this central resource, it would be difficult for families or ...

Baby Boxes May Harm Mothers and Infants Despite Good ...

Modern infant abandonment boxes possess alarms, video monitors, and temperature controls critical to keeping an infant alive.

Patient Safety Bundles For Safer Birth | AIM

Patient safety bundles are collections of evidence-informed best practices, developed by multidisciplinary experts, which address clinically specific conditions ...

Supply kits for antenatal and childbirth care: a systematic review

Supply kits are considered a potential strategy to improve maternal and child health, as they provide medication or diagnostic tests at the same time.

'Safety bundles' may reduce pregnancy-related deaths ...

'Safety bundles' may reduce pregnancy-related deaths, particularly among Black women. By Laura Williamson, American Heart Association News.