Inpatient Versus Outpatient Cervical Ripening

From 1990 to 2010, the rates of induction of labor increased from 9.6% to 23.8%(1). Recent
data from 2014 reports a rate of 23.2%(2). Labor induction may be medically indicated, in
cases in which the risk of continuing pregnancy is greater than delivery, or in some cases
electively after 39 weeks of gestation.

Prior to starting an induction of labor, a digital exam is performed to determine the status
of the cervix in terms of its dilatation, effacement, position, softness, and fetal station.
If the cervical status is considered favorable for labor, then generally oxytocin is started
to induce uterine contractions. If the cervix is not considered favorable, a method of
cervical ripening is employed to induce physical changes in the cervix that make it more
favorable for labor.

This process involves inflammatory infiltration and release of metalloproteases that degrade
collagen and result in cervical remodeling(3). The primary benefit of cervical ripening is
reducing the length of labor; however, some studies have suggested that it may lower the rate
of cesarean section(4,5). The Bishop score (see table 1) is used as a scoring tool to
determine the status of the cervix(6). Most studies define a score of 6 or less as an
unfavorable cervix, while a score of greater than 8 is favorable, and has a similar
probability of vaginal delivery to spontaneous labor(7).

Commonly used methods for cervical ripening include pharmacologic forms such as synthetic
prostaglandin E1 (PGE1, i.e. misoprostol) and prostaglandin E2 (PGE2, i.e. dinoprostone), or
mechanical ripening with balloon (i.e. Foley) catheters.

Quality improvement, increasing efficiency, and decreasing cost continue to be challenges for
individual hospitals and the entire health care system. Induction of labor, especially with
an unfavorable cervix, is associated with longer lengths of stay for patients, which results
in increased cost(8).

Foley catheters are a safe, inexpensive and effective option for cervical ripening. A study
by Sciscione et al in 2001 compared Foley bulb use in inpatient versus outpatient settings
and found the outpatient use to be as effective for cervical ripening. The primary objective
of this study was to compare efficacy of these two approaches and the outcomes were similar.
There were no cases of endomyometritis or chorioamnionitis(9). While they did report a
shorter amount of time in the hospital with outpatient management, this was not a primary
outcome of the study and they did not compare costs. Recently there has been an increased
focus on the costs of medical care and patient satisfaction. Consequently, these are
increasingly important outcomes that research needs to focus on. It is our hope that the
findings of our study will support the use of outpatient pre-induction of labor cervical
ripening and result in a more efficient use of resources and improved patient satisfaction.

The purpose of this study is to compare the use of a Foley catheter for cervical ripening in
the inpatient and outpatient setting, in order to evaluate the difference in the amount of
time spent on labor and delivery during induction of labor, as well as the difference in
costs. An important secondary outcome we plan to evaluate as well is patient satisfaction.
This will be a randomized controlled trial, with the study population being pregnant women at
≥ 37 weeks of gestation undergoing induction of labor. The projected time-frame will be from
October 2016 to June 2018. The expected outcome is that outpatient cervical ripening with
Foley catheter use will result in shorter lengths of stay on labor and delivery and less cost
than inpatient Foley catheter use in patients undergoing induction of labor. Additionally, we
anticipate greater patient satisfaction with outpatient management.

Inclusion Criteria:

- Pregnancies at least 37 weeks' gestation, undergoing induction of labor, with an
unfavorable cervix, defined as a Bishop score ≤ 6

- The fetus must be in the cephalic presentation

- Indications for induction of labor include, but are not limited to, the following:

- Elective induction of labor at 39 weeks' gestation

- Intrauterine growth restriction

- Chronic hypertension

- Diabetes

- Gestational diabetes

- Prior stillbirth

- Other medical indications for induction of labor, as deemed appropriate by the
obstetric provider, such as Systemic Lupus Erythematosus, Cholestasis of
Pregnancy etc.

Exclusion Criteria:

- Gestational hypertension

- Preeclampsia

- Non-reassuring fetal testing

- Multi-fetal gestation

- Oligohydramnios

- Fetal anomaly

- Less than 37 weeks

- Bishop score > 6

- Ruptured membranes

- Contraindication to vaginal delivery including: active Herpes lesion, HIV VL >1000
copies/mL, placenta previa, vasa previa, breech presentation, prior classical cesarean
section or transfundal myomectomy

- Poor access to telephone or transportation

- Latex allergy

- Any other condition for which the managing physician or investigator deem outpatient
management inappropriate.

- Currently participating in another clinical trial