Please select the eligibility criteria that correspond to the clinical trial below.
Title: Foley OR MisO for the Management of Induction (FOR MOMI) Trial
Brief Summary: The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.


Options:
A: Inclusion Criteria:

1. Cervix \< 3 cm dilated. If 2cm dilated, must be \< 80% effaced.
2. Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
3. Singleton gestation
4. Cephalic presentation

Exclusion Criteria:

1. Regular uterine contractions (more frequent than every 5 minutes)
2. PROM
3. Prior transverse uterine incision or any obstetric contraindication to labor
4. Fever (defined as a temperature of 38°C or higher)
5. Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
6. Fetal death
7. Placenta previa
8. Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
9. Non-reassuring fetal heart rate pattern
10. HIV
B: Inclusion Criteria

* Nulliparous women aged 18 or above
* BMI ≥ 30 at the time of labor induction
* Singleton gestation
* Cephalic presentation (includes successful external cephalic version)
* Intact fetal membranes
* Unfavorable cervix (Bishop score of ≤ 6)
* Gestational age ≥ 32 weeks

Exclusion Criteria

* Patient not candidate for IOL with misoprostol as deemed by the treating physician
* Multiple gestation
* Major fetal anomalies
* Fetal demise
C: Inclusion Criteria:

* Patients 15 years of age or older.
* Diagnosed to be pregnant with an indication for induction of labor.
* Having a Bishop score of 4 points or less.
* Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of \>28 weeks.
* Willingness to comply with the protocol for the duration of the study.
* Have signed an informed consent.

Exclusion Criteria:

* Any contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation).
* Ruptured membranes.
* Previous cesarean section or any uterine scar.
* Documented labor.
* Suspected fetal distress necessitating immediate intervention.
* Proven malignancy of the cervix.
* Active inflammatory or purulent condition of the lower genital tract.
D: Inclusion Criteria:

* All women 18 years of age or greater
* singleton gestation
* vertex presentation
* 37 weeks gestational age or greater
* undergoing an IOL
* bishop score less than or equal to 6
* cervical dilation less than or equal to 2cm

Exclusion Criteria:

* All women less than 18 years of age
* Contraindication for vaginal delivery
* Prior cesarean delivery
* Multiple gestation
* Intrauterine fetal demise
* Fetal anomaly
* HIV
* Unable to consent/ non-English speaking
* Non-reassuring fetal heart rate
* Patients with hemolysis elevated liver enzymes and low platelets
* Eclampsia
* Intrauterine growth restriction (IUGR) 5th percentile with abnormal dopplers
* IUGR less than 10th percentile with reversed end diastolic flow
* Recurrent late decelerations w
* Continuous contractions more than 3 times in 10 minutes at onset of IOL (given that this is a contraindication to misoprostol use at our institution)
* Bishop score is greater than 6
* Cervical dilation greater than or equal to 2cm
* Confirmed ruptured membranes

Answer: D