Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
Induction of labor, or causing labor to start before it otherwise starts spontaneously, is
 sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant.
 Labor induction often begins with cervical ripening, in which various methods are used to
 prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases
 the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant
 women are admitted to the hospital at the start of this process and remain inpatient until
 after the baby is born.

 There is increasing interest in allowing the mother to return to her own home during the very
 first part of this process. She may be more satisfied in a more comfortable environment with
 her family. Growing scientific evidence supports use of the Foley catheter as an approach to
 outpatient cervical ripening. The Foley catheter is a safe, effective method that is already
 used often in the inpatient setting. It does not cause increased health risks for either
 mother or baby. Previous research studies have shown that it is just as safe and effective
 when women return to their own homes with a Foley catheter and that women spend less time in
 the hospital before delivery. More information is needed before this becomes a standard of
 care. This research study will allow pregnant women to return home for the first night of
 their labor induction with a Foley catheter in place. In the morning they will return to the
 hospital and stay until after delivery. They will be compared to a group of women who remain
 in the hospital for their entire labor induction. The benefits to going home during labor
 induction may include increasing maternal satisfaction and optimizing the use of resources in
 the hospital.
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.

 When the patient returns in the morning, the induction will be continued at the discretion of
 the providing obstetric team. The remainder of her care during the first, second, and third
 stages of labor will be at the discretion of the providing team. The patient will have
 continuous fetal monitoring. All patients' labor progress will be monitored using a
 partogram. Cesarean delivery will not be performed for arrest of labor or failed induction
 unless all criteria have been met as outlined by the Family Birth Center Workgroup protocol
 made effective 6/2/14.

 Inpatient usual care group:

 If the patient was randomized or chose the control group (inpatient usual care), she will
 arrive to the Family Birth Center at 1900 to undergo induction of labor. 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. She will be
 included or excluded from the study based on the above information. Induction of labor may
 proceed at the discretion of the providing obstetric team. Cervical ripening should be
 performed with either 25 mcg vaginal misoprostol every 4 hours with a maximum of six doses or
 a 30 Fr Foley catheter filled with 60 cc normal saline. The patient may need both methods
 during her inpatient stay if her cervix is unfavorable. A Foley catheter will be favored
 during the cervical ripening phase if there is tachysystole and/or a nonreassuring fetal
 heart tracing precluding further misoprostol administration, provided the Bishop score is
 still <6. The remainder of her care during the first, second, and third stages of labor will
 be at the discretion of the providing team. All patients' labor progress will be monitored
 using a partogram. Cesarean delivery will not be performed for arrest of labor or failed
 induction unless all criteria have been met as outlined by the Family Birth Center Workgroup
 protocol made effective 6/2/14.

 Follow up

 Each mother was asked to complete a survey before leaving the hospital describing her
 experience and satisfaction with the cervical ripening process (both study designs. Primary
 and secondary endpoints will be collected from neonatal and maternal charts through 42 days
 after the patient's delivery or the date of the patient's final postpartum clinic visit,
 whichever comes last.
Inclusion Criteria

 1. Pregnant women at ≥37 weeks gestation by reliable dating criteria as determined by the
 American College of Obstetricians and Gynecologists (i.e. gestational age supported by
 one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones
 auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+
 weeks ago)

 2. Scheduled induction of labor with indication and timing supported by the Family Birth
 Center induction of labor guideline entitled "Induction of labor: Indications and
 Timing"

 3. Singleton gestation

 4. Cephalic presentation

 5. Amniotic fluid index greater than or equal to 5 centimeters

 6. Formal prenatal ultrasound documenting the absence of placenta previa

 7. Bishop score <6 and cervical dilation <3cm

 8. The woman is able to give appropriate consent and has undergone an informed consent
 process.

 9. Maternal age ≥ 18 years old at the time of consent.

 Exclusion Criteria

 1. New diagnosis requiring immediate hospitalization for monitoring (such as new onset
 hypertensive disease of pregnancy)

 2. Vaginal bleeding

 3. Active labor

 4. Premature rupture of membranes as determined by positive ferning and as supported by
 pooling of fluid in the vaginal vault.

 5. Uterine tachysystole (>5 contractions in 10 minutes)

 6. Nonreassuring fetal heart tracing before or after Foley placement

 7. Chorioamnionitis or maternal fever

 8. Intrauterine fetal demise

 9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine
 surgery)

 10. Abnormal placentation including a low lying placenta

 11. Prior cesarean delivery

 12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound)

 13. Known fetal anomaly

 14. Human immunodeficiency virus, Hepatitis C, or active herpes infection

 15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor

 16. Pregestational diabetes

 17. Rh isoimmunization

 18. Non-English speaking

 19. Distance from the hospital over 60 minutes by car, unreliable communication via
 telephone, or unreliable transportation