Outpatient Foley Catheter Compared to Usual Inpatient Care for Cervical Ripening: a Randomized Controlled Trial

This study began as a randomized controlled trial, but due to difficulty enrolling and high screen-failure rates, was modified to a prospective study design allowing participants to choose the arm they wished to participate in at the time of providing informed consent. The intervention group (both designs) was comprised of low risk pregnant women who will have a Foley catheter placed followed by dismissal home with return in the morning for continuation of the labor induction process. The control group consists of women (both designs) who will remain inpatient during the entire cervical ripening phase followed by continuation of the labor induction process in the inpatient setting.

Low risk pregnant women at term will be enrolled in clinic after their providers have recommended induction of labor for a specific indication. They will be educated about induction of labor, the Foley catheter, and the proposed research study. If they would like to participate, they will be consented in the clinic. For the RCT design, a computer-generated randomization would occur on the morning of the planned induction, and the patients will be contacted by phone to inform them of their assigned group. The randomization will be stratified by parity and BMI.

Outpatient Foley catheter group:

If the patient was randomized or chose the intervention group (outpatient Foley), she underwent the following. She will present to the Family Birth Center in the evening at 1900. She will undergo a nonstress test (NST), an ultrasound for fetal presentation and amniotic fluid index, and a cervical exam with calculation of a Bishop score. The patient will be asked if she is having regular, painful contractions, decreased fetal movement, vaginal bleeding, leakage of fluid from the vagina concerning for rupture of membranes, or fevers or chills. A Foley catheter will be placed if the following criteria have been met: the nonstress test is reactive and reassuring (without the presence of ≥ 3 variable decelerations in a 20 minute period, late-appearing decelerations, or any deceleration lasting ≥1 minute), the fetal presentation is cephalic, the amniotic fluid index is 5 centimeters or more, the Bishop score is <6, the cervical dilation is <3 cm, and she has no other clinical characteristics that exclude her from the trial as described in the inclusion/exclusion criteria. A 30 French Foley will be placed either digitally or with speculum assistance. It will be inflated with 60 cc of normal saline and taped to the patient's inner thigh. The fetal heart rate tracing will be monitored for 1 hour after Foley placement. The patient will be sent home if the following criteria are met: the fetal heart rate tracing is reactive and category I; there is no evidence of rupture of membranes, spontaneous labor, or vaginal bleeding more than spotting; and no other exclusion criteria are present. Before discharge, the patient may receive pharmacologic pain relief in the form of one dose of acetaminophen and/or fentanyl.

The patient will be instructed to return to the Family Birth Center at 0700 the following day. She will be given detailed verbal and written instructions of when to contact and return to the Family Birth Center before the morning. She will be provided with the 24 hour direct access line for the Family Birth Center to call with any questions or concerns. If the Foley catheter is expulsed at home, she is to record the time of expulsion. She does not need to return to the Family Birth Center earlier than planned due to expulsion.