Outpatient Foley Catheter for Induction of Labor

(COMFORT Trial)

Recruiting at 3 trial locations

Overseen By Meaghan McCabe, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Anticoagulants

Disqualifiers: Preeclampsia, Hypertension, Diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to delivery

2300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a Foley catheter (a small tube inserted into the cervix) at home can reduce the need for cesarean deliveries and lower health risks for both mothers and babies compared to initiating the process in the hospital. It targets women over 37 weeks pregnant, expecting their first child, and whose doctors plan to use this method to induce labor. Women with a single baby in a head-down position who can safely return to the hospital with the catheter are suitable candidates for this study. As an unphased study, this trial allows participants to contribute to innovative research that could enhance childbirth experiences for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on therapeutic anticoagulation (blood thinners) or have certain conditions like severe chronic hypertension or type 1 diabetes, you may not be eligible to participate.

What prior data suggests that the outpatient Foley catheter is safe for cervical ripening?

Research has shown that using a Foley catheter to prepare the cervix for labor is safe outside the hospital. Studies indicate that this method can reduce hospital time, potentially leading to a quicker delivery after admission. Evidence also suggests fewer complications for both mothers and babies compared to methods like vaginal prostaglandins. These findings indicate that using a Foley catheter outside the hospital is generally well-tolerated and carries minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about outpatient cervical ripening with a Foley catheter because it offers a new approach to inducing labor that could make the process more convenient and comfortable for pregnant individuals. Unlike the standard induction methods, which typically require a hospital stay, this method allows the cervical ripening process to begin at home. This could potentially reduce hospital time and related costs, and help expectant mothers feel more at ease in a familiar environment. By starting the induction process outside the hospital, researchers hope to improve the overall birthing experience without compromising safety or effectiveness.

What evidence suggests that outpatient Foley catheter is effective for induction of labor?

Studies have shown that using a Foley catheter to prepare the cervix for labor is effective and safe for women whose cervix is not yet ready for childbirth. In this trial, one group of participants will undergo outpatient cervical ripening with a Foley catheter. Research indicates this method can significantly reduce hospital time. Keeping the Foley balloon in place for 6 hours may speed up the time to birth, even if it doesn't fully prepare the cervix initially. Overall, using the Foley catheter at home to start labor appears promising for reducing hospital time and may also lower the chances of needing a Cesarean delivery. ^{2 4 6 7 8}

Who Is on the Research Team?

Lisa Levine, MD, MSCE

Principal Investigator

University of Pennsylvaina

Alison G Cahill, MD, MSCI

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

The COMFORT trial is for first-time pregnant women at term (37-42 weeks) who need labor induced and meet specific health criteria. They must have an intact amniotic sac, baby in head-down position, a low Bishop score indicating the cervix isn't very dilated or ready for labor, speak English or Spanish, have safe housing and transportation to return to the hospital.

Inclusion Criteria

Eligible for induction of labor

Cephalic presentation

Intact membranes

Exclusion Criteria

I have sickle cell disease.

Known oligohydramnios (DVP <2cm)

Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cervical ripening using a Foley catheter, either in an outpatient or inpatient setting

Up to delivery

1 visit (in-person)

Follow-up

Participants are monitored for maternal and neonatal outcomes, including morbidity and satisfaction, up to 6 weeks postpartum

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Outpatient Foley catheter

Trial Overview This study compares two ways of preparing the cervix for labor induction in nulliparous women: using a Foley catheter at home (outpatient) versus the standard method done in the hospital (inpatient). The goal is to see if outpatient ripening lowers Cesarean delivery rates and improves mother/baby health outcomes.

How Is the Trial Designed?

Group I: Outpatient cervical ripening with Foley Experimental Treatment 1 Intervention

Cervical ripening will begin with a Foley balloon in the outpatient setting

Group II: Standard of care Inpatient cervical ripening Active Control 1 Intervention

Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent

Outpatient Foley catheter is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Foley catheter for:

• Cervical ripening for labor induction

Approved in European Union as Foley catheter for:

• Cervical ripening for labor induction

Approved in Canada as Foley catheter for:

• Cervical ripening for labor induction

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study of 120 pregnant women with prior cesarean deliveries, the single-balloon catheter was found to be more effective for cervical ripening compared to the double-balloon catheter.

While both catheters are safe and lead to comparable neonatal outcomes, the double-balloon catheter resulted in longer time between insertion and expulsion, indicating that the choice of catheter should be tailored to individual circumstances for optimal labor induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus. Xing, Y., Li, N., Ji, Q., et al.[2020]

The Foley catheter is equally effective for cervical ripening in both outpatient and inpatient settings, with no significant differences in the change of Bishop scores after placement (3.0 for both groups).

Women in the outpatient group avoided an average of 9.6 hours of hospitalization without any adverse events or maternal morbidity, suggesting a safe and efficient alternative to inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Sciscione, AC., Muench, M., Pollock, M., et al.[2019]

In a randomized controlled trial involving 129 parous women, outpatient cervical ripening with a transcervical Foley catheter did not significantly reduce the time from labor ward admission to delivery compared to inpatient catheter placement with simultaneous oxytocin infusion.

The study found that the average time to delivery was similar between the outpatient group (12.4 hours) and the inpatient group (13.5 hours), indicating that outpatient cervical ripening may not provide a time advantage in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Kuper, SG., Jauk, VC., George, DM., et al.[2019]

Balloon catheters are an effective and safe method for outpatient cervical ripening in low-risk pregnancies, showing similar efficacy to traditional methods like vaginal prostaglandin E2, while avoiding complications like uterine hyperstimulation.

Outpatient induction with balloon catheters leads to shorter hospital stays, lower costs, and higher patient satisfaction compared to inpatient methods, with low complication rates (0.3-1.5%) and no severe adverse outcomes reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient Induction of Labor - Are Balloon Catheters an Appropriate Method? Rath, W., Stelzl, P., Kehl, S.[2022]

Induction of labor is a common practice in obstetrics, and if studies like the ARRIVE trial support delivering all women at 39 weeks, the demand for labor induction will likely rise significantly.

Outpatient preinduction cervical ripening using the Foley catheter appears to be a safe and effective strategy for low-risk women, potentially improving patient satisfaction and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Place for Outpatient Preinduction Cervical Ripening? Leopold, B., Sciscione, A.[2018]

Outpatient induction of labor using a Foley catheter is safe and effective, showing no significant differences in cesarean delivery rates or infection rates compared to inpatient procedures, based on a study of 485 women.

A high level of maternal satisfaction was reported among outpatients, with 85.3% expressing contentment with their experience, indicating that outpatient induction is a viable option for many women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foley catheter induction of labor as an outpatient procedure. Kruit, H., Heikinheimo, O., Ulander, VM., et al.[2018]

Outpatient balloon catheter insertion for labor induction significantly reduces the cesarean delivery rate compared to inpatient procedures, with a risk ratio of 0.63 based on data from 740 patients across 8 randomized controlled trials.

The outpatient method also leads to shorter hospital stays and a more favorable increase in the Bishop score, indicating better cervical readiness for labor, without increasing the risk of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient versus inpatient balloon catheter insertion for labor induction: A systematic review and meta-analysis of randomized controlled trials. Abdelhakim, AM., Shareef, MA., AlAmodi, AA., et al.[2021]

A systematic review of 26 studies involving 8292 women found that the risk of adverse events during cervical ripening with a balloon catheter is very low, with a prevalence of complications ranging from 0.0 to 0.26%.

The most common adverse event reported was 'pain/discomfort', suggesting that while some discomfort may occur, the overall safety profile supports the potential for outpatient use in low-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. Diederen, M., Gommers, J., Wilkinson, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7815336/

Outpatient Induction of Labor – Are Balloon Catheters an ... The use of balloon catheters in patients with an unripe cervix has been shown to be an effective and safe method of cervical priming. Balloon ...

2. contemporaryobgyn.net contemporaryobgyn.net/view/outpatient-cervical-ripening-with-a-foley-catheter

Outpatient cervical ripening with a Foley catheter Data show that outpatient cervical ripening with a Foley catheter is safe and can significantly decrease the overall length of hospital stay. In ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933323002999

Six compared with 12 hours of Foley balloon placement for ... A planned 6-hour Foley balloon placement shortens the time to birth, despite less cervical ripening at Foley balloon catheter removal and more additional ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14247

Outpatient vs inpatient Foley catheter induction of labor in ... Duration of hospital stay was significantly shorter in our outpatient arm. This finding is consistent with a systematic review and meta-analysis ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12478980/

Comparative Effectiveness, Safety, and Cost-Effectiveness ... Gu et al. [16] demonstrated that a shorter 12-hour Foley catheter ripening duration was more effective for achieving vaginal delivery within 24 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29211328/

Safety of the balloon catheter for cervical ripening in ... Balloon catheter for cervical ripening appears to be safe enough to evaluate its use in the outpatient setting.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34991144/

Outpatient Cervical Ripening with Balloon Catheters Outpatient balloon cervical ripening in low-risk patients is associated with a decreased amount of time from admission to labor and delivery until delivery.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933323002847

Six vs 12 hours of Foley catheter balloon placement in the ... Balloon catheters compared with vaginal prostaglandins for labor induction lead to fewer adverse perinatal events, with similar cesarean delivery rates and ...