Adults 14 to 45, female only, with Preterm Birth or Health Care Utilization. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Screening Rate (Feasibility)Primary· Screening phase (Up to 1 week prior to enrollment)
The study team will compare the number of potentially eligible participants to those who are screened for eligibility. The number screened will be defined as the number of people whose are reviewed to approach for enrollment. The number of potentially eligible participants will be considered the number of women with preterm births with Medicaid insurance.
Group
Value
95% CI
Intervention Arm
49
Enrollment Rate (Feasibility)Primary· Screening phase (Up to one week prior to enrollment)
The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
Group
Value
95% CI
Intervention Arm
13
Reasons for Non-participation (Acceptability)Primary· Screening phase (Up to 1 week prior to enrollment)
For women who decline enrollment we will ask them, if they are willing, to provide reasons for non-participation and potential study modifications that might have encouraged them to participate. Responses will be tabulated and reviewed for potential themes.
Too much going on during hospital stay
Group
Value
95% CI
People Who Declined Participation
3
Perceived services not needed
Group
Value
95% CI
People Who Declined Participation
2
Recently moved to the area
Group
Value
95% CI
People Who Declined Participation
1
No reason given
Group
Value
95% CI
People Who Declined Participation
3
Retention Rate (Feasibility)Primary· Enrollment through six months
The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.
Group
Value
95% CI
Intervention Arm
9
Number of Completed Assessments (Feasibility)Primary· Enrollment through six months
The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.
Group
Value
95% CI
Intervention Arm
31
Change in Autonomy SupportSecondary· Baseline and 3 months
Autonomy support will be measured with the short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.
Group
Value
95% CI
Intervention Arm
-2.5
± 11.1
Change in Autonomous MotivationSecondary· Baseline and 6 months
Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90) with a higher score indicating higher emotion regulation strategy.
Group
Value
95% CI
Intervention Arm
-1.1
± 9.9
Count of Preventive Care VisitsSecondary· 6 months
This will include postpartum visits, visits for contraceptive management, routine preventive care visits, and visits to follow-up on complications of pregnancy (secondary prevention). Visits will be abstracted from the health record and from interventionist records.
Group
Value
95% CI
Intervention Arm
2.2
± 1.3
Proportion of Recommended Care CompletedSecondary· 6 months
This Outcome Measure reports the average percentage of the recommended care plan completed among participants. Recommended care will be abstracted from a care plan completed within the first two weeks after enrollment. Completed care will be abstracted from the health record and from interventionist records.
Group
Value
95% CI
Intervention Arm
73
± 35
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05120843.