Cervical Ripening as an Outpatient Method Using the Foley: A Randomized Trial (COMFORT)
Recruiting
18-55 years
Female
Phase
N/A
1260 participants needed
1 Location
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
01 Aug 2024.
Study ID: 851906
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