Outpatient Foley Catheter for Induction of Labor
(COMFORT Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pennsylvania
Must not be taking: Anticoagulants
Disqualifiers: Preeclampsia, Hypertension, Diabetes, HIV, others
No Placebo Group
Approved in 3 jurisdictions
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.
12345Is 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.
23467How 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.
23458Eligibility 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
+5 more
Exclusion Criteria
I have sickle cell disease.
Known oligohydramnios (DVP <2cm)
Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery)
+12 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Outpatient cervical ripening with FoleyExperimental Treatment1 Intervention
Cervical ripening will begin with a Foley balloon in the outpatient setting
Group II: Standard of care Inpatient cervical ripeningActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Christiana Care Health Services, Inc.Newark, DE
University of Texas at AustinAustin, TX
University of UtahSalt Lake City, UT
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
References
Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. [2019]To assess whether outpatient cervical ripening with a transcervical Foley catheter in parous women undergoing elective induction of labor shortens the total duration of time from admission to the labor ward until delivery.
Foley catheter induction of labor as an outpatient procedure. [2018]The aim of our study was to introduce outpatient induction of labor by Foley catheter, and to compare outcomes and preferences between in-patients and outpatients.
Outpatient versus inpatient balloon catheter insertion for labor induction: A systematic review and meta-analysis of randomized controlled trials. [2021]To compare between outpatient and inpatient balloon catheter insertion for labor induction.
Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. [2019]To compare use of the Foley catheter for preinduction cervical ripening in an inpatient versus outpatient setting.
Is There a Place for Outpatient Preinduction Cervical Ripening? [2018]Induction of labor continues to be one of the most commonly performed tasks in obstetrics. If trials like the National Institute of Child Health and Human Development's ARRIVE trial show that delivery for all women at 39 weeks provides a significant advantage in pregnancy outcomes, the number of women who require induction of labor will considerably increase. Strategies to improve patient/family satisfaction, decrease resource allocation and costs, and assure safety are paramount. Although there are many potential candidates, it seems that outpatient preinduction cervical ripening with the Foley catheter meets these criteria in a properly selected group of low-risk women.
Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus. [2020]In obstetrics, labor induction is a common procedure. It has been proved that both single balloon catheters (Foley's catheter) and double balloon catheters (Cook cervical ripening balloon) are effective and relatively safe in cervical ripening and labor induction. This research aimed to compare the efficacy of single and double balloon catheter in the induction of labor with scarred uterus.
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]It has been suggested that cervical ripening with a balloon catheter for labour induction can be done in an outpatient setting in low-risk pregnancies. Introduction of such an approach needs to be accompanied with monitoring of potential complications. Therefore the existence and frequency of any associated adverse event during cervical ripening needs to be established.
Outpatient Induction of Labor - Are Balloon Catheters an Appropriate Method? [2022]As the number of labor inductions in high-income countries has steadily risen, hospital costs and the additional burden on obstetric staff have also increased. Outpatient induction of labor is therefore becoming increasingly important. It has been estimated that 20 - 50% of all pregnant women requiring induction would be eligible for outpatient induction. 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 catheters are as effective as the vaginal administration of prostaglandin E 2 or oral misoprostol. The advantage of using a balloon catheter is that it avoids uterine hyperstimulation and monitoring is less expensive. This makes balloon catheters a suitable option for outpatient cervical ripening. Admittedly, intravenous administration of oxytocin to induce or augment labor is required in approximately 75% of cases. Balloon catheters are not associated with a higher risk of maternal and neonatal infection compared to vaginal PGE 2 . Low-risk pregnancies (e.g., post-term pregnancies, gestational diabetes) are suitable for outpatient cervical ripening with a balloon catheter. The data for high-risk pregnancies are still insufficient. The following conditions are recommended when considering an outpatient approach: strict selection of appropriate patients (singleton pregnancy, cephalic presentation, intact membranes), CTG monitoring for 20 - 40 minutes after balloon placement, the patient must be given detailed instructions about the indications for immediate readmission to hospital, and 24-hour phone access to the hospital must be ensured. According to reviewed studies, the balloon catheter remained in place between 12 hours ("overnight") and 24 hours. The most common reason for readmission to hospital was expulsion of the balloon catheter. The advantages of outpatient versus inpatient induction of cervical ripening with a balloon catheter were the significantly shorter hospital stay, the lower costs, and higher patient satisfaction, with both procedures having been shown to be equally effective. Complication rates (e.g., vaginal bleeding, severe pain, uterine hyperstimulation syndrome) during the cervical ripening phase are low (0.3 - 1.5%); severe adverse outcomes (e.g., placental abruption) have not been reported. Compared to inpatient induction of labor using vaginal PGE 2 , outpatient cervical ripening using a balloon catheter had a lower rate of deliveries/24 hours and a significantly higher need for oxytocin; however, hospital stay was significantly shorter, frequency of pain during the cervical ripening phase was significantly lower, and patients' duration of sleep was longer. A randomized controlled study comparing outpatient cervical priming with a balloon catheter with outpatient or inpatient induction of labor with oral misoprostol would be of clinical interest.