Improving health and wellness for women after preterm birth
Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth
This study is testing a new support program for women who have had a preterm birth to see if it can help them improve their health and well-being after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 14 Years to 45 Years |
| Sex | Female |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05756634 on ClinicalTrials.gov |
What this trial studies
This study evaluates a behavioral intervention called Care Coordination After Preterm Birth (CCAPB) aimed at improving health outcomes for women who have experienced preterm birth. The intervention includes training for care coordinators in motivational interviewing techniques to better support participants. Women will be enrolled from a postpartum unit or within four weeks of giving birth, and their experiences with the intervention will be assessed for acceptability and feasibility. The study will measure outcomes through participant feedback and completion of study data collection.
Who should consider this trial
Good fit: Ideal candidates are women aged 14 to 45 with a history of preterm birth and Medicaid insurance.
Not a fit: Patients who have undergone sterilization or plan to move away from the area within six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance health and wellness for women after preterm birth, potentially reducing future health risks.
How similar studies have performed: Other studies have shown promise with similar care coordination approaches, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 14 - 45 * History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. ) * 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. * History of organ failure or malignancies.
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Emily Gregory, MD, MPH — Children's Hospital of Philadelphia
- Study coordinator: Emily Gregory, MD, MPH
- Email: gregorye@chop.edu
- Phone: 2154193122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.