Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
Labor, Induced, Cervix Uteri-Diseases
About this trial
This is an interventional treatment trial for Labor, Induced focused on measuring Cervical ripening, Labor induction, Outpatient, Mechanical, Hygroscopic
Eligibility Criteria
Inclusion Criteria:
- Pregnant woman whose plan of care is induction of labor
- Maternal age between 18 and 45 years
- Understanding and capable to sign informed consent
- Singleton pregnancy
- Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
- Live fetus in cephalic presentation
- Intact membranes
- Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced
Exclusion Criteria:
- Active labor
- Active genital herpes
- Chorioamnionitis
- Transfundal uterine or cervical surgery
- Previous cesarean delivery
- Non-reassuring fetal status
- Need for continuous maternal or fetal monitoring during ripening
- Contraindication for vaginal delivery
- Active vaginal bleeding
- Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
- Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)
- Intrauterine growth restriction (estimated fetal weight <10 percentile)
- Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)
- Fetal anomaly
- Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)
- Poor or no access to a telephone and cannot be placed in the hotel
- Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)
Sites / Locations
- Columbia University Irving Medical Center
- UTMB Galveston
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Outpatient Dilapan-S
Inpatient Dilapan-S
After Dilapan-S® placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours
After Dilapan-S® placement, subjects 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.