Trial results for a study investigating care coordination and motivational interviewing for women with a recent preterm birth, including those with depression, were posted on ClinicalTrials.gov on 2026-01-27. The study was terminated with 13 participants enrolled.
Background
Preterm birth can significantly impact a woman's health and well-being, often leading to complex needs that span physical health, mental health, and social support. Conditions such as depression, tobacco use, and challenges with contraceptive usage and overall healthcare utilization are common in this population. Effective care coordination and supportive interventions like motivational interviewing are crucial to address these multifaceted needs and improve postpartum outcomes. This study aimed to test the feasibility of such an intervention to refine its implementation for this vulnerable group.
Trial design
This terminated study, designated as Phase NA, was a small single-arm open trial that enrolled 13 participants. It aimed to test the feasibility and refine an adaptation of care coordination for women after preterm birth. The conditions investigated included Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, and Depression. The trial focused on assessing intervention implementation and refining the approach for future testing.
Key results
The trial reported several key measurements related to feasibility and preliminary outcomes:
- Screening Rate (Feasibility): 49 participants were screened for the intervention arm.
- Enrollment Rate (Feasibility): 13 participants were enrolled in the intervention arm.
- Reasons for Non-participation (Acceptability): Among people who declined participation, reasons were reported with counts of 3, 2, 1, and 3 people for various reasons.
- Retention Rate (Feasibility): 9 participants were retained in the intervention arm.
- Number of Completed Assessments (Feasibility): A total of 31 completed assessments were recorded for the intervention arm.
- Change in Autonomy Support: In the intervention arm, the mean change was -2.5 (Standard Error 11.1 units on a scale).
- Change in Autonomous Motivation: In the intervention arm, the mean change was -1.1 (Standard Deviation 9.9 units on a scale).
- Count of Preventive Care Visits: The mean count was 2.2 (Standard Deviation 1.3 visits) in the intervention arm.
- Proportion of Recommended Care Completed: The mean proportion was 73 (Standard Deviation 35 percentage) in the intervention arm.
What this means
The posted results offer insights into the feasibility and initial outcomes of adapting care coordination and motivational interviewing for women after preterm birth. The enrollment of 13 participants and retention of 9 participants provide data on the practical aspects of implementing such an intervention. While changes in autonomy support and motivation, and completion of recommended care, show preliminary numerical values, these are from a small, terminated single-arm study. These findings contribute to understanding the challenges and potential of delivering care coordination in this specific context, informing future intervention design and larger-scale feasibility or efficacy trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05120843, titled "Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth", were posted on 2026-01-27 on clinicaltrials.gov.