Clinical Trials

Inclusion Criteria:

• 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).
• 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.”
• Singleton gestation.
• Cephalic presentation.
• Amniotic fluid index greater than or equal to 5 centimeters.
• Formal prenatal ultrasound documenting the absence of placenta previa.
• Bishop score < 9 and cervical dilation < 3cm.
• The woman is able to give appropriate consent and has undergone an informed consent process.
• Maternal age ≥ 18 years old at the time of consent.

Exclusion Criteria:

• New diagnosis requiring immediate hospitalization for monitoring (such as preeclampsia).
• Vaginal bleeding.
• Active labor.
• Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault.
• Uterine tachysystole (> 5 contractions in 10 minutes).
• Nonreassuring fetal heart tracing before or after Foley placement.
• Chorioamnionitis or maternal fever.
• Intrauterine fetal demise.
• Contraindication to vaginal delivery, relative or absolute (i.e., transfundal uterine surgery).
• Abnormal placentation including a low lying placenta.
• Prior cesarean delivery.
• Intrauterine growth restriction (growth < 10th percentile by formal ultrasound).
• Known major fetal anomaly.
• Human immunodeficiency virus, Hepatitis C, or active herpes infection.
• Maternal cardiopulmonary disease requiring cardiac monitoring during labor.
• Pregestational diabetes.
• Rh isoimmunization.
• Non-English speaking.