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

• ClinicalTrials.gov Identifier: NCT02566005
• Recruitment Status: Completed
• First Posted: October 1, 2015
• Results First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Sponsor: St. Luke's-Roosevelt Hospital Center
• Information provided by (Responsible Party): St. Luke's-Roosevelt Hospital Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pregnancy	Device: misoprostol; Device: Foley bulb	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
• Study Start Date: September 2015
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: misoprostol group; The women in the misoprostol only group will receive 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	Device: misoprostol; 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).; Other Name: cytotec
Active Comparator: misoprostol and foley bulb group; Women in the combination group will receive vaginal misoprostol per standard protocol. In addition, 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. Oxytocin will be initiated in those patients who were not in labor after expulsion or removal of the catheter.	Device: misoprostol; 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).; Other Name: cytotec; Device: Foley bulb; 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 Name: foley bulb (ballon)

Outcome Measures

Primary Outcome Measures :

1. The Time Interval From Induction to Delivery: All Participants [ Time Frame: Day 1 ]
   During labor from the start of the induction to the delivery
2. Time (Hours) From Induction to Delivery: Nulliparous [ Time Frame: Day 1 ]
3. Time (Hours) From Induction to Delivery: Multiparous [ Time Frame: Day 1 ]
4. Time From Induction to Delivery: VD [ Time Frame: Day 1 ]
   Time (hours) from induction to delivery: Vaginal Delivery (VD)
5. Time From Induction to Delivery: CD [ Time Frame: Day 1 ]
   Time (hours) from induction to delivery: Cesarean Delivery (CD)
6. Per Treatment Protocol: Time (Hours) From Induction to Delivery [ Time Frame: day 1 ]

Secondary Outcome Measures :

1. The Time From Induction Until to Active Phase Labor [ Time Frame: Day 1 ]
2. The Time From Active Phase to Delivery [ Time Frame: Day 1 ]
3. Incidence of Chorioamnionitis [ Time Frame: Day 1 ]
4. Incidence of Uterine Tachysystole [ Time Frame: Day 1 ]
5. Incidence of Patient Discomfort [ Time Frame: Day 1 ]
6. Estimated Blood Loss [ Time Frame: Day 1 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, New York

Mount Sinai Roosevelt

New York, New York, United States, 10019

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

• Principal Investigator: Zainab Al-Ibraheemi, MD; Mount Sinai St Luke's Roosevelt Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT02566005
• Other Study ID Numbers: 15-0032
• First Posted: October 1, 2015
• Results First Posted: March 27, 2018
• Last Update Posted: March 27, 2018
• Last Verified: February 2018

Keywords provided by St. Luke's-Roosevelt Hospital Center:

Misoprostol; Induction; Foley

Additional relevant MeSH terms:

Misoprostol; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Anti-Ulcer Agents; Gastrointestinal Agents; Oxytocics