Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
Brief Summary: Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.


Options:
A: 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
B: Inclusion Criteria:

* singleton pregnancy
* vertex presentation
* unfavorable cervix(Bishop's score less than or equal to 6)
* greater than 24 weeks gestation

Exclusion Criteria:

* fetal malpresentation
* multifetal gestation
* spontaneous labor
* more than 5 uterine contractions in 10 minutes
* contraindication to prostaglandins
* non-reassuring fetal heart rate tracing
* intrauterine growth restriction
* anomalous fetus
* fetal demise
* previous cesarean delivery or other significant uterine surgery
C: Inclusion Criteria

* Term 37 weeks or more, singleton in cephalic presentation
* Age 18 years and older
* Patient admitted for induction of labor

Exclusion Criteria:

* Malpresentation
* Preterm labor less than 37 weeks of gestation
* Patients with fetal anomalies
* Premature rupture of membranes
* If the cervix is closed and unable to place the foley bulb
* Multiple gestation
* Non-reassuring fetal heart tracing
* Contraindication to misoprostol
* Contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, marginal previa, macrosomia, etc). History of prior uterine surgery such as cesarean section or myomectomy
D: 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.

Answer: A