An interventional study of CADENCE program in Pregnancy Related and Opioid Use Disorder, sponsored by University of South Florida. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
The proposed project seeks to use public health and clinical data on opioid use disorders (OUD) outcomes for mother and infants, which is the leading cause of death to mothers one year after deliver and can lead to neonatal withdrawal syndrome (NOWS) and other poor outcomes. Insufficient or incomplete data about OUD and lack of integrated programs for OUD treatment during pregnancy can be barriers to providing optimal care to mothers and infants.
Maternal opioid use disorder (OUD) is the leading cause of maternal mortality in the first year after delivery nationwide. OUD also contributes substantially to out-of-home placements in the child welfare system. Medication for OUD (MOUD) is the primary standard of treatment, however, access to MOUD and prenatal care is limited, siloed, and fragmented in Florida. Gaps in access to and continuity of healthcare (prenatal, postpartum, pediatric, pharmacological and behavioral health) and other services for mothers in OUD recovery lead to poor outcomes for parent, child and family. There is also insufficient data integration, due to inconsistent data collection methods or use of diagnostic codes, to identify mother-infant dyads affected by OUD that could inform optimal care at the local level. Single-site studies that integrate substance use disorder programs in pregnancy have been shown to improve neonatal and maternal outcomes. With that in mind, the long-term goal of this study is to leverage high-quality local and timely data to improve OUD outcomes before, during, and after pregnancy with an integrated care approach that can be replicated throughout the state. The objective of the proposed project is to consolidate multiple streams of public health and clinical healthcare data to analyze equitable access and outcomes for families affected by maternal OUD for use in quality improvement cycles to rapidly refine our integrated CADENCE (Continuous and Data-Driven Care) Program. Our central hypothesis is that integrated, continuous, data-driven care will improve CADENCE patient outcomes. We will test this hypothesis through the following aims: 1) create an interactive data dashboard for maternal, neonatal, and infant outcomes for pregnancies affected by OUD; 2) pilot the CADENCE program and rapidly refine using a data-driven approach.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 10 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: CADENCE program
The CADENCE program will consist of an integrated care pathway between the OBOT clinic, obstetric clinic, pediatric clinic, and behavioral health with multiple entry points, including emergency rooms, existing mobile harm reduction clinics, obstetric clinics, and delivery facilities. We also seek to provide wrap-around care for these families with peer support, care navigation, and robust community support, using existing Hillsborough County resources such as doula programs, Healthy Start, and other home visiting programs.
MOUD at delivery hospitalization
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
Time frame: At delivery hospitalization
Decreased pharmacologically treated NOWS
Medication clinically required for NOWS (yes/no)
Time frame: At delivery
First trimester entry to prenatal care
First prenatal care visit before 14 weeks gestational age (yes/no)
Time frame: Prenatal care, up to 40 weeks
Prenatal care adequacy
Kotelchuck index (score)
Time frame: Prenatal care, up to 40 weeks
Hepatitis C screening
Hepatitis C antibody screen collected during prenatal care (yes/no)
Time frame: Prenatal care, up to 40 weeks
NICU admissions
Admission to the NICU during delivery admission for any reason (yes/no)
Time frame: At delivery hospitalization
Hospital length of stay (neonate)
Number of days in hospital during delivery admission (#)
Time frame: At delivery hospitalization
Department of Children and Families out-of-home placement
Neonate placed in care of another family or with a foster family who is not the biological parents. This does not include planned adoptions. (yes/no)
Time frame: At delivery hospitalization
Breastfeeding at discharge
Exclusive breastfeeding at discharge from delivery admission (yes/no)
Time frame: At delivery hospitalization
Enrollment in community supports and services.
Proportion of referrals to connection/enrollment in services (%)
Time frame: Prenatal up to 1 year old
Acceptability of CADENCE Program
Patient satisfaction gauged by qualitative interview and quantitative surveys
Time frame: Prenatal up to 1 year old
Feasibility of CADENCE Program
Number of patients recruited per month, number of patients enrolled in program
Time frame: Prenatal up to 1 year old
Trialability of CADENCE Program
Ability to integrate into clinical flow as gauged by Clinical staff qualitative interview and quantitative surveys
Time frame: Prenatal up to 1 year old
Plan to share: Yes — Quantitative data: The raw data at the individual level will be available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data-sharing agreements must be approved by our institutional IRB and follow university protocols.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University of South Florida