A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor

1. Objectives The hypothesis is that cervical ripening using a foley bulb together with
vaginal misoprostol (cytotec) will result in shorter induction to delivery time compared
with vaginal misoprostol alone

2. Background The rate of induction of labor in the United States is approximately 20% of
all births. Induction of labor can result in prolonged labor and increases the rate of
cesarean delivery, both of which are associated with increased maternal and neonatal
morbidity. Ripening of an unfavorable cervix has become an integral part of the labor
induction process. The best method of cervical ripening remains controversial; no one
method has proved to be superior. Women requiring labor induction often present with
unfavorable cervices which can lead to a prolonged induction. Cervical ripening is often
done to increase the likelihood of successful labor induction.

Misoprostol (cytotec) is PGE1 analog and widely used for cervical ripening and is the
preferred method of induction of labor based on the safety reported literature. Low-dose
(25 mcg) intravaginal misoprostol appears to be safe and effective for cervical ripening
in term pregnancy for patients without a history of cesarean section. Compared with
other cervical ripening methods, misoprostol has an increased rate of vaginal delivery
within 24 hours without significant differences in cesarean section rates or fetal
outcomes.

The use of the foley catheter for induction of labor was first described by Krause in
1953. In 1967 Embrey and Mollison reported a 94% successful induction rate after using
the foley catheter for cervical ripening. Since then, several studies found
transcervical foley catheters as effective as prostaglandins preparations for ripening
without an increased risk of uterine rupture.

There are many proposed methods for induction of labor including mechanical
(transcervical foley bulb) and chemical methods (prostaglandins, oxytocin). A number of
randomized trials have compared the use of foley bulb, oxytocin and misoprostol in
different combinations for induction of labor and their results are contradictory with
regards to induction to delivery time, successful vaginal delivery and labor
complications.

There are two studies that evaluated the foley bulb with misoprostol comparing to
misoprostol alone. Carbone el al study, found the mean induction to delivery time was 3
hours shorter with the combination of the foley bulb and vaginal misoprostol when
compared to vaginal misoprostol alone. In a study by Chung et al, there was no
difference in the induction to delivery time.

Therefore given the contradicting results regarding induction of labor using foley bulb
with misoprostol or misoprostol alone, the purpose of our study is to determine if there
is a decrease in the induction to delivery time with one method versus the other.

3. Setting of the Human Research Research will take place on the labor and delivery floor
of Roosevelt Hospital

4. Study Design a) Recruitment Methods Women admitted to labor and delivery at Roosevelt
Hospital will be asked to participate in the study if they are to have an induction of
labor at or beyond term (37weeks of gestation). Patients will be screened and those
meeting the eligibility criteria will be approached. Informed consent will be obtained.

After a discussion about the study with an eligible interested subject, an investigator will
review the consent with them. The investigator will give the potential subject the
opportunity to ask any questions and have them answered. Potential participants will be given
the opportunity to think about the study. (Only those investigators listed as study personnel
and authorized to obtain consent, will obtain informed consent). Once a patient wishes to
join the study and informed consent is obtained, the subject can participate. Each subject
will receive a signed copy of the consent form. The subject can withdraw from the study at
any time without any retribution.

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