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

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02566005
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 20

Study Details

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	N/A

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.

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

2. 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
• 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: Sep 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 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 Names: 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 Names: 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 Names: foley bulb (ballon)

Outcome Measures

Primary Outcome Measures

1. The Time Interval From Induction to Delivery: All Participants [Day 1]

   During labor from the start of the induction to the delivery

2. Time (Hours) From Induction to Delivery: Nulliparous [Day 1]

3. Time (Hours) From Induction to Delivery: Multiparous [Day 1]

4. Time From Induction to Delivery: VD [Day 1]

   Time (hours) from induction to delivery: Vaginal Delivery (VD)

5. Time From Induction to Delivery: CD [Day 1]

   Time (hours) from induction to delivery: Cesarean Delivery (CD)

6. Per Treatment Protocol: Time (Hours) From Induction to Delivery [day 1]

Secondary Outcome Measures

1. The Time From Induction Until to Active Phase Labor [Day 1]

2. The Time From Active Phase to Delivery [Day 1]

3. Incidence of Chorioamnionitis [Day 1]

4. Incidence of Uterine Tachysystole [Day 1]

5. Incidence of Patient Discomfort [Day 1]

6. Estimated Blood Loss [Day 1]

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Misoprostol; Induction; Foley
• Additional relevant MeSH terms: Misoprostol

Study Results

Participant Flow

Recruitment Details	During the study period from September 2015-July 2016, 4767 patients delivered at Mount Sinai West and of these, 1423 deliveries followed induction of labor. A total of 200 patients consented to participate in the study and were randomized, 100 to each group.

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Period Title: Overall Study
STARTED	100	100
COMPLETED	92	94
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group	Total
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.5 (5.9)	31.8 (6.3)	31.6 (6.1)
Sex: Female, Male (Count of Participants)
Female	100 100%	100 100%	200 100%
Male	0 0%	0 0%	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.8 (6.8)	31.22 (5.7)	31.56 (6.3)
Parity (Count of Participants)
Nulliparous	74 74%	70 70%	144 72%
Multiparous	26 26%	30 30%	56 28%
Gestational age at delivery (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	39.4 (1.4)	39.6 (1.3)	39.4 (1.4)
Indication for induction (Count of Participants)
Oligohydramnios/Polyhydramnios	21 21%	22 22%	43 21.5%
Post-EDC	21 21%	21 21%	42 21%
Hypertensive disorder	28 28%	20 20%	48 24%
Gestational diabetes/Diabetes	11 11%	11 11%	22 11%
Advanced maternal age	1 1%	4 4%	5 2.5%
Others	18 18%	22 22%	40 20%
Bishop score at misoprostol placement (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.71 (1.78)	3.17 (1.94)	2.9 (1.8)
Mode of delivery (Count of Participants)
Spontaneous Vaginal Delivery	48 48%	59 59%	107 53.5%
Forceps Vaginal Delivery	2 2%	1 1%	3 1.5%
Vacuum Vaginal Delivery	12 12%	10 10%	22 11%
Cesarean Delivery	38 38%	30 30%	68 34%
Indications for cesarean delivery (Count of Participants)
Non-reassuring Fetal tracing	20 20%	19 19%	39 19.5%
Arrest of dilation	9 9%	6 6%	15 7.5%
Arrest of descent	5 5%	4 4%	9 4.5%
Failed induction of labor	3 3%	1 1%	4 2%
Others	1 1%	0 0%	1 0.5%
Insurance (Count of Participants)
Private	59 59%	53 53%	112 56%
Service	41 41%	47 47%	88 44%
Anesthesia (Count of Participants)
None	4 4%	6 6%	10 5%
Neuraxial anesthesia	96 96%	91 91%	187 93.5%
General Anesthesia	0 0%	3 3%	3 1.5%

Outcome Measures

1. Primary Outcome

Title	The Time Interval From Induction to Delivery: All Participants
Description	During labor from the start of the induction to the delivery
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	100	100
Mean (Standard Deviation) [hours]	20.97 (10.27)	16.27 (7.6)

2. Primary Outcome

Title	Time (Hours) From Induction to Delivery: Nulliparous
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

for nulliparous participants

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	74	70
Mean (Standard Deviation) [hours]	22.7 (10.58)	18.15 (7.87)

3. Primary Outcome

Title	Time (Hours) From Induction to Delivery: Multiparous
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

for nulliparous participants

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	26	30
Mean (Standard Deviation) [hours]	15.99 (7.4)	11.89 (4.6)

4. Primary Outcome

Title	Time From Induction to Delivery: VD
Description	Time (hours) from induction to delivery: Vaginal Delivery (VD)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	62	70
Mean (Standard Deviation) [hours]	18.87 (8)	15.55 (6.7)

5. Primary Outcome

Title	Time From Induction to Delivery: CD
Description	Time (hours) from induction to delivery: Cesarean Delivery (CD)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	38	30
Mean (Standard Deviation) [hours]	24.38 (12.49)	17.95 (9.29)

6. Primary Outcome

Title	Per Treatment Protocol: Time (Hours) From Induction to Delivery
Time Frame	day 1

Outcome Measure Data

Analysis Population Description

those participants on treatment protocol

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	92	94
Mean (Standard Deviation) [hours]	20.5109 (10.09)	16.6814 (7.47)

7. Secondary Outcome

Title	The Time From Induction Until to Active Phase Labor
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	100	100
Mean (Standard Deviation) [hours]	17.43 (8.6)	12.81 (5.83)

8. Secondary Outcome

Title	The Time From Active Phase to Delivery
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	100	100
Mean (Standard Deviation) [hours]	3.11 (2.75)	3.76 (3)

9. Secondary Outcome

Title	Incidence of Chorioamnionitis
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	100	100
Count of Participants [Participants]	8 8%	4 4%

10. Secondary Outcome

Title	Incidence of Uterine Tachysystole
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	100	100
Count of Participants [Participants]	12 12%	6 6%

11. Secondary Outcome

Title	Incidence of Patient Discomfort
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

data not collected

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	0	0

12. Secondary Outcome

Title	Estimated Blood Loss
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Misoprostol Group	Misoprostol and Foley Bulb Group
Arm/Group Description	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.)	25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
Measure Participants	100	100
Mean (Standard Deviation) [ml]	493.3 (274)	490.5 (304.1)

Adverse Events

Arm/Group Title	Misoprostol Group		Misoprostol and Foley Bulb Group
Arm/Group Description	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.)		25mcg of misoprostol per vagina every 4hours per the standard hospital 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.
All Cause Mortality
	Misoprostol Group		Misoprostol and Foley Bulb Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Serious Adverse Events
	Misoprostol Group		Misoprostol and Foley Bulb Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Misoprostol Group		Misoprostol and Foley Bulb Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.