Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

Group Assigned to Outpatient Cervical Ripening After Dilapan-S® placement, subject will be
monitored for at least 30 minutes. If no contraindications, such as tachysystole, active
vaginal bleeding, rupture of membranes or nonreassuring fetal testing (defined as minimal or
absent variability, abnormal baseline, or presence of decelerations) evidence of labor, or
other serious medical conditions deemed by the clinical staff or the attending physician to
preclude outpatient cervical ripening develop after insertion, the subjects will be
randomized. After randomization subject will record the pain she experienced during insertion
in the patient's survey (see Appendix 3). Those subjects randomized to outpatient ripening
will be given the option to either return home or to stay in a hotel if transportation is an
issue. The cost for the hotel will be covered by the study budget. Subjects will be allowed
to ambulate, shower and perform regular activity during that period. "Nothing per vagina"
will be allowed (incl. intercourse, tampons etc.).

Group Assigned to Inpatient Cervical Ripening Subjects randomized to inpatient management
will be admitted to L&D unit and standard clinical protocol will be initiated for cervical
ripening and labor induction. During the period of 12 hours of cervical ripening subject is
to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart
rate monitoring. No other interventions are to occur during this period of 12 hours, unless
clinically indicated.

Labor Induction and Labor Management of the subject after the initial 12 hours of
pre-induction or following the earlier removal or spontaneous expulsion of the dilator will
be the same for both groups and at the discretion of the clinical team. Additional ripening
(mechanical or prostaglandins) and/or oxytocin may or may not be needed. If needed, duration,
type and dose of additional ripening agents and oxytocin will be documented.

Routine intrapartum care will be provided and relevant data collected by the subject's
managing obstetrical team.

Inclusion Criteria:

1. Pregnant woman whose plan of care is induction of labor

2. Maternal age between 18 and 45 years

3. Understanding and capable to sign informed consent

4. Singleton pregnancy

5. Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first
trimester dating ultrasound)

6. Live fetus in cephalic presentation

7. Intact membranes

8. Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60%
effaced

Exclusion Criteria:

1. Active labor

2. Active genital herpes

3. Chorioamnionitis

4. Transfundal uterine or cervical surgery

5. Previous cesarean delivery

6. Non-reassuring fetal status

7. Need for continuous maternal or fetal monitoring during ripening

8. Contraindication for vaginal delivery

9. Active vaginal bleeding

10. Abnormal placental location or adherence (placenta previa or unresolved low lying
placenta)

11. Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)

12. Intrauterine growth restriction (estimated fetal weight <10 percentile)

13. Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)

14. Fetal anomaly

15. Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)

16. Poor or no access to a telephone and cannot be placed in the hotel

17. Absence of support person ( no adult accompanying the subject during outpatient
cervical ripening period)