Cervical Ripening as an Outpatient Method Using the Foley: A Randomized Trial (COMFORT)

Brief description of study

Induction of labor normally starts in the hospital. The purpose of this research study is to look at starting your induction at home and see if it lowers your chances of having a c-section compared to starting your induction in the hospital. First time moms are being asked to volunteer so that we can better understand an alternative way to begin the induction process of labor. We will be using a Foley balloon catheter to start your labor at home, which is most often how labor induction is started in the hospital as well.

Detailed description of study

In this study, you will have your labor induced with one of the following: • Cervical Foley in the outpatient setting ⚬ This includes having a small plastic catheter placed into the cervix through the vagina. Once placed, the small balloon at the tip of the catheter is filled with water until it is the size of a walnut. This helps soften the cervix and get it ready for labor ⚬ This group will be sent home until their scheduled in-hospital induction time or until labor starts • Cervical ripening in the inpatient setting: ⚬ This group will preferentially have the same cervical Foley placed. ⚬ Other routine medications used for induction may also be used. This group will have cervical ripening upon admission to the hospital and will stay admitted for their entire induction

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Pregnant
Age: Between 18 Years - 55 Years
Gender: Female

Eligible for induction of labor
Live singleton gestation ≥37 weeks and <42 weeks
Nulliparous, ≥18 years of age with no previous deliveries >20 weeks
Cephalic presentation
Intact membranes
Bishop score ≤8 and cervical dilation <3 cm
English or Spanish speaking (Able to read/understand consent and instructions)
Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter

Updated on 09 Mar 2024. Study ID: 851906

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).