Clinical trial NCT02566005: A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
Official title: A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Misoprostol
Induction
Foley
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Time Interval From Induction to Delivery: All Participants
timeFrame: Day 1
measure: Time (Hours) From Induction to Delivery: Nulliparous
timeFrame: Day 1
measure: Time (Hours) From Induction to Delivery: Multiparous
timeFrame: Day 1
measure: Time From Induction to Delivery: VD
timeFrame: Day 1
measure: Time From Induction to Delivery: CD
timeFrame: Day 1
measure: Per Treatment Protocol: Time (Hours) From Induction to Delivery
timeFrame: day 1
Secondary outcomes:
measure: The Time From Induction Until to Active Phase Labor
timeFrame: Day 1
measure: The Time From Active Phase to Delivery
timeFrame: Day 1
measure: Incidence of Chorioamnionitis
timeFrame: Day 1
measure: Incidence of Uterine Tachysystole
timeFrame: Day 1
measure: Incidence of Patient Discomfort
timeFrame: Day 1
measure: Estimated Blood Loss
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Roosevelt
state: New York
Study officials:
affiliation: Mount Sinai St Luke's Roosevelt Hospital
name: Zainab Al-Ibraheemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Ibraheemi Z, Brustman L, Bimson BE, Porat N, Rosenn B. Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):23-29. doi: 10.1097/AOG.0000000000002403.