Pregnancy RelatedCADENCENCT05609669
Continuous And Data-drivEN CarE (CADENCE) Pilot
A study testing CADENCE program in people with Pregnancy Related and Opioid Use Disorder, run by University of South Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Opioid Use Disorder
- What is being tested?
- CADENCE program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 30 Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known opioid use disorder over the age of 18 years old who are pregnant
Who cannot join
- Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida/Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Continuous And Data-drivEN CarE (CADENCE)
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.
Read the detailed description
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.
- Conditions
- Pregnancy Related, Opioid Use Disorder
- Being tested
- CADENCE program
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADENCE programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CADENCE program pilot | Experimental | Not described Receives: Other: CADENCE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOUD at delivery hospitalization
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
Measured: At delivery hospitalization
Decreased pharmacologically treated NOWS
Medication clinically required for NOWS (yes/no)
Measured: At delivery
Secondary outcomes (8)
First trimester entry to prenatal care
First prenatal care visit before 14 weeks gestational age (yes/no)
Measured: Prenatal care, up to 40 weeks
Prenatal care adequacy
Kotelchuck index (score)
Measured: Prenatal care, up to 40 weeks
Hepatitis C screening
Hepatitis C antibody screen collected during prenatal care (yes/no)
Measured: Prenatal care, up to 40 weeks
NICU admissions
Admission to the NICU during delivery admission for any reason (yes/no)
Measured: At delivery hospitalization
Hospital length of stay (neonate)
Number of days in hospital during delivery admission (#)
Measured: 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)
Measured: At delivery hospitalization
Breastfeeding at discharge
Exclusive breastfeeding at discharge from delivery admission (yes/no)
Measured: At delivery hospitalization
Enrollment in community supports and services.
Proportion of referrals to connection/enrollment in services (%)
Measured: Prenatal up to 1 year old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start23 Aug 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Marshall, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609669
- Sponsor's protocol ID
- STUDY004953
- Acronym
- CADENCE
- Status last verified
- Nov 2025
- First submitted
- 2 Nov 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ratta AK, Elger RS, Vermeer W, Wright T, Oxner A, Fryer K, Marshall J. Referral linkages to support pregnant and postpartum individuals with opioid use disorders in Florida: a social network analysis. Addict Sci Clin Pract. 2026 May 8;21(1):42. doi: 10.1186/s13722-026-00675-1.
PubMed 42104470
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous And Data-drivEN CarE (CADENCE)
- ClinicalTrials.gov ID
- NCT05609669
- Acronym / sponsor ID
- CADENCE / STUDY004953
- Conditions
- Pregnancy Related, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Nov 2022 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CADENCE program pilot | Experimental | Other: CADENCE program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with known opioid use disorder over the age of 18 years old who are pregnant
Key exclusion criteria (1 listed)
- Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant
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 |
|---|---|---|
| CADENCE programThe 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. | Other | CADENCE program pilot |
Primary outcome
MOUD at delivery hospitalization
Time frame: At delivery hospitalization
Patients on subutex or methadone treatment at delivery hospitalization (yes/no)
Decreased pharmacologically treated NOWS
Time frame: At delivery
Medication clinically required for NOWS (yes/no)
8 secondary outcomes
First trimester entry to prenatal care
Time frame: Prenatal care, up to 40 weeks
Prenatal care adequacy
Time frame: Prenatal care, up to 40 weeks
Hepatitis C screening
Time frame: Prenatal care, up to 40 weeks
NICU admissions
Time frame: At delivery hospitalization
Hospital length of stay (neonate)
Time frame: At delivery hospitalization
Department of Children and Families out-of-home placement
Time frame: At delivery hospitalization
Breastfeeding at discharge
Time frame: At delivery hospitalization
Enrollment in community supports and services.
Time frame: Prenatal up to 1 year old
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 10 Nov 2025.
- Derived from this study: PubMed 42104470Ratta AK, Elger RS, Vermeer W, Wright T, Oxner A, Fryer K, Marshall J. Referral linkages to support pregnant and postpartum individuals with opioid use disorders in Florida: a social network analysis. Addict Sci Clin Pract. 2026 May 8;21(1):42. doi: 10.1186/s13722-026-00675-1.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Jennifer Marshall, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADENCE program in people with Pregnancy Related and Opioid Use Disorder, run by University of South Florida 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOUD at delivery hospitalization (time frame: At delivery hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05609669, which also lists 1 linked publication.
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 10 Nov 2025.