Evaluating the use of outpatient Foley catheters for cervical ripening in first-time pregnant women.
A multicenter pragmatic randomized trial evaluating effectiveness and safety of outpatient Foley catheter for cervical ripening in nulliparous women: a Type 1 hybrid effectiveness-implementation study
This study is looking at whether using Foley catheters at home can help first-time pregnant women get ready for labor more comfortably and safely, with the hope of reducing the need for cesarean deliveries.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Pennsylvania NIH-funded |
| Lab location | 1 site (Philadelphia, United States) |
| Project ID | NIH-10880571 on NIH RePORTER |
What this research studies
This research investigates the effectiveness and safety of using Foley catheters for cervical ripening in a home setting for women who are pregnant for the first time. By shifting the initial phase of labor induction from a hospital to an outpatient environment, the study aims to reduce the rate of cesarean deliveries. The approach focuses on allowing women to experience improved comfort and relaxation at home, which may lead to better labor outcomes. The study will involve multiple centers and will assess both the effectiveness and safety of this method compared to traditional inpatient procedures.
Who could benefit from this research
Good fit: Ideal candidates for this research are nulliparous women who are undergoing labor induction.
Not a fit: Patients who are not first-time mothers or those who do not require cervical ripening will likely not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to a significant reduction in cesarean delivery rates for first-time mothers, improving overall birth experiences.
How similar studies have performed: Previous smaller studies have shown promising results for outpatient cervical ripening, but this is the first large-scale trial to evaluate its effectiveness and safety.
Where this research is happening
Philadelphia, United States
- University of Pennsylvania — Philadelphia, United States (Active)
Researchers
- Principal investigator: Levine, Lisa Danielle — University of Pennsylvania
- Study coordinator: Levine, Lisa Danielle
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.