Outpatient Foley Catheter for Induction of Labor

(COMFORT Trial)

Recruiting in Newark (>99 mi)

+3 other 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

Trial Summary

What is the purpose of this trial?

A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.

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 data supports the effectiveness of the treatment Outpatient Foley catheter for induction of labor?

Research suggests that using a Foley catheter (a small balloon inserted into the cervix to help it open) for labor induction can be effective when done as an outpatient procedure, especially in low-risk women. It may improve patient satisfaction and reduce hospital resources compared to inpatient procedures. ^{1 2 3 4 5}

Is the Foley catheter safe for inducing labor in an outpatient setting?

Research suggests that using a Foley catheter for inducing labor is generally safe, whether done in an outpatient or inpatient setting. Studies have shown it to be effective and relatively safe for cervical ripening and labor induction, with monitoring for potential complications recommended. ^{2 3 4 6 7}

How does the outpatient Foley catheter treatment for induction of labor differ from other treatments?

The outpatient Foley catheter treatment for induction of labor is unique because it allows for cervical ripening outside the hospital, reducing hospital stay and costs while maintaining effectiveness. Unlike some drug-based methods, it avoids uterine hyperstimulation and requires less intensive monitoring, making it a suitable option for low-risk pregnancies. ^{2 3 4 5 8}

Research Team

Lisa Levine, MD, MSCE

Principal Investigator

University of Pennsylvaina

Alison G Cahill, MD, MSCI

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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

I can read and understand English or Spanish.

Cephalic presentation

Exclusion Criteria

I have sickle cell disease.

Known oligohydramnios (DVP <2cm)

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Foley catheter induction of labor as an outpatient procedure. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Outpatient versus inpatient balloon catheter insertion for labor induction: A systematic review and meta-analysis of randomized controlled trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Is There a Place for Outpatient Preinduction Cervical Ripening? [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus. [2020]

7. England 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. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Outpatient Induction of Labor - Are Balloon Catheters an Appropriate Method? [2022]