TerminatedNot Applicable

Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth

Stopped: This study was terminated once we had collected sufficient information to proceed with the subsequent pilot trial.

United States13 participantsStarted 2022-02-03

Plain-language summary

This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.

Who can participate

Age range14 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female
✓. Less than 45 years old
✓. History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
✓. Intention to seek pediatric care at one of two pediatric primary care sites
✓. Medicaid insurance

Exclusion criteria

✕. History of sterilization procedure.
✕. Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
✕. Limited English proficiency

What they're measuring

Screening Rate (Feasibility)

Timeframe: Screening phase (Up to 1 week prior to enrollment)

Enrollment Rate (Feasibility)

Timeframe: Screening phase (Up to one week prior to enrollment)

Reasons for Non-participation (Acceptability)

Timeframe: Screening phase (Up to 1 week prior to enrollment)

Retention Rate (Feasibility)

Timeframe: Enrollment through six months

Number of Completed Assessments (Feasibility)

Timeframe: Enrollment through six months

Care Coordination Fidelity (Feasibility)

Timeframe: Enrollment through six months

Motivational Interviewing (MI) Fidelity (Feasibility)

Timeframe: Enrollment through six months

Trial details

NCT IDNCT05120843

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-23

Results submitted2024-08-15

View on ClinicalTrials.gov More Preterm Birth trials

Who can participate

Age range14 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female
✓. Less than 45 years old
✓. History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
✓. Intention to seek pediatric care at one of two pediatric primary care sites
✓. Medicaid insurance

Exclusion criteria

✕. History of sterilization procedure.
✕. Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
✕. Limited English proficiency

What they're measuring

Screening Rate (Feasibility)

Timeframe: Screening phase (Up to 1 week prior to enrollment)

Enrollment Rate (Feasibility)

Timeframe: Screening phase (Up to one week prior to enrollment)

Reasons for Non-participation (Acceptability)

Timeframe: Screening phase (Up to 1 week prior to enrollment)

Retention Rate (Feasibility)

Timeframe: Enrollment through six months

Number of Completed Assessments (Feasibility)

Timeframe: Enrollment through six months

Care Coordination Fidelity (Feasibility)

Timeframe: Enrollment through six months

Motivational Interviewing (MI) Fidelity (Feasibility)

Timeframe: Enrollment through six months