Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Pr… (NCT05120843) | Clinical Trial Compass
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 range
14 Years – 45 Years
Sex
FEMALE
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Screening Rate (Feasibility)
Timeframe: Screening phase (Up to 1 week prior to enrollment)
2
Enrollment Rate (Feasibility)
Timeframe: Screening phase (Up to one week prior to enrollment)
3
Reasons for Non-participation (Acceptability)
Timeframe: Screening phase (Up to 1 week prior to enrollment)