A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
Condition: Pregnancy
Study type: Interventional

Summary: 
      A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital
      labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb
      together with vaginal misoprostol will result in shorter induction to delivery time compared
      with vaginal misoprostol alone
    

Detailed description: 
      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.
    

Intervention name(s): misoprostol; Foley bulb
Intervention type(s): Device; Device
Intervention description(s): 25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist).; a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours.
Other intervention name(s): cytotec; foley bulb (ballon)
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Misoprostol; Induction; Foley