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Behavioural Intervention

Maternity care home model (MCHM) for Perinatal Morbidity (ENHANCED Trial)

N/A

Recruiting

Led By Sindhu K Srinivas, MD, MSCE

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 16-55

Patients must be able to read and understand English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-randomization to 1 year postpartum

Awards & highlights

ENHANCED Trial Summary

"This trial aims to test a new model of maternity care for Black, indigenous, and people of color patients to reduce severe maternal morbidity. Participants will either receive the new integrated care model or the standard

Who is the study for?

This trial is for BIPOC patients experiencing perinatal morbidity. It's designed to help those who are pregnant and will follow them through one year after giving birth. The study seeks participants willing to be randomly assigned to different types of prenatal care.Check my eligibility

What is being tested?

The study tests a maternity care home model (MCHM) against standard care. MCHM offers office-based prenatal care integrated with social services, while standard involves typical office visits with separate social service referrals.See study design

What are the potential side effects?

Since this trial focuses on models of care rather than medication, traditional side effects aren't the focus. However, there may be differences in satisfaction or stress levels based on the type of care received.

ENHANCED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 16 and 55 years old.

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I can read and understand either English or Spanish.

ENHANCED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-randomization to 1 year postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-randomization to 1 year postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-randomization to 1 year postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Severe Maternal Morbidity (SMM)

Secondary outcome measures

Birth satisfaction (BSS-R survey)

Composite adverse neonatal outcome

Edinburgh Postnatal Depression Scale (EPDS) Screening

+10 more

ENHANCED Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Maternity care home model (MCHM)Experimental Treatment1 Intervention

Office based prenatal care integrated with comprehensive social services within the maternity care home model.

Group II: Usual care armActive Control1 Intervention

Office based prenatal care with individually outsourced social service referrals.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,879,983 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,374,261 Total Patients Enrolled

Sindhu K Srinivas, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study include individuals who are older than 30 years of age?

"Individuals aged 16 to 55 years are eligible for participation, with no one younger or older meeting the criteria."

Answered by AI

Which group of individuals is considered the most suitable candidates for enrollment in this clinical research study?

"Patients aged between 16 and 55 who have perinatal morbidity are eligible for inclusion in this study, which aims to recruit a total of 2300 participants."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"Affirmative. As per the details on clinicaltrials.gov, this study is actively searching for suitable candidates. Initially shared on 1/30/2024 and last modified on 2/5/2024, the research aims to enroll a total of 2300 participants from two distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Sindhu Srinivas, MD 2024. "Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245057.