CROWN: Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT02639429
• Collaborator: (none)
• Enrollment: 236
• Location: 1
• Arms: 2
• Duration (Months): 29.7
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Labor Induction; Cesarean Delivery	Drug: Vaginal Misoprostol; Device: Foley Balloon + Vaginal Misoprostol	Phase 4

Detailed Description

Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.

Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team.

In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jun 24, 2018
• Actual Study Completion Date: Jun 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined approach: Foley Balloon + Vaginal Misoprostol These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.	Device: Foley Balloon + Vaginal Misoprostol
Active Comparator: Single approach: Vaginal Misoprostol only These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.	Drug: Vaginal Misoprostol; Other Names: Cytotec

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Need for Cesarean Delivery [Induction to delivery]

Secondary Outcome Measures

1. Indication for Cesarean Delivery [Induction to delivery]

   Categories of Indications for Cesarean Delivery: = Cephalopelvic disproportion = Failed induction/Failure to progress = Cord prolapse = Non-reassuring fetal tracing = Malpresentation = Placental abruption = Other

2. Induction-to-delivery Interval in Hours [Induction to delivery]

3. Number of Participants With a Need for Oxytocin Augmentation [Induction to delivery]

4. Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities [Induction to delivery]

   Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window.

5. Number of Participants With Clinical Chorioamnionitis [Induction to delivery]

   Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid.

6. Number of Participants With a Need for Operative Vaginal Delivery [Induction to delivery]

7. Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity [Induction to discharge (approximately 5 days)]

   Measures of maternal morbidity assessed: Maternal ICU admission Postpartum endometritis Surgical-site infections prior to discharge Venous thromboembolism Need for transfusion Maternal death

8. Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) [From delivery to neonatal discharge (approximately 2 to 7 days)]

9. Number of Newborns With Transient Tachypnea (TTN) [From delivery to neonatal discharge (approximately 2 to 7 days)]

10. Number of Newborns With Respiratory Distress Syndrome (RDS) [From delivery to neonatal discharge (approximately 2 to 7 days)]

11. Number of Newborns With Meconium Aspiration Syndrome [From delivery to neonatal discharge (approximately 2 to 7 days)]

12. Number of Newborns With Culture-proven Sepsis [From delivery to neonatal discharge (approximately 2 to 7 days)]

13. Number of Newborns With Seizures [From delivery to neonatal discharge (approximately 2 to 7 days)]

14. Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity [From delivery to neonatal discharge (approximately 2 to 7 days)]

    Measures of neonatal morbidity assessed: Apgar score ≤ 7 at 5 mins Umbilical cord potential of hydrogen (pH) < 7.1 Neonatal injury: brachial plexus injury, fracture Perinatal death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Nulliparous women aged 18 or above

• BMI ≥ 30 at the time of labor induction

• Singleton gestation

• Cephalic presentation (includes successful external cephalic version)

• Intact fetal membranes

• Unfavorable cervix (Bishop score of ≤ 6)

• Gestational age ≥ 32 weeks

Exclusion Criteria

• Patient not candidate for IOL with misoprostol as deemed by the treating physician

• Multiple gestation

• Major fetal anomalies

• Fetal demise

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 16, 2018

More Information

Publications

None provided.

• Responsible Party: Mesk A.Jawad Alrais, Clinical Resident, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT02639429
• Other Study ID Numbers: HSC-MS-15-0895
• First Posted: Dec 24, 2015
• Last Update Posted: Aug 26, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Misoprostol

Study Results

Participant Flow

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Period Title: Overall Study
STARTED	113	123
COMPLETED	113	123
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only	Total
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol	Total of all reporting groups
Overall Participants	113	123	236
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (5.8)	23.4 (6.1)	24.3 (6.0)
Sex: Female, Male (Count of Participants)
Female	113 100%	123 100%	236 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African Amercian	25 22.1%	26 21.1%	51 21.6%
Caucasian	14 12.4%	15 12.2%	29 12.3%
Hispanic	68 60.2%	74 60.2%	142 60.2%
Other	6 5.3%	8 6.5%	14 5.9%
Region of Enrollment (Count of Participants)
United States	113 100%	123 100%	236 100%
Gestational Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	38.7 (5.2)	38.6 (5.4)	38.6 (5.4)
Number of participants who are married (Count of Participants)
Count of Participants [Participants]	64 56.6%	67 54.5%	131 55.5%
Number of participants who had prenatal care (Count of Participants)
Count of Participants [Participants]	110 97.3%	121 98.4%	231 97.9%
Number of participants with government subsidized insurance (Count of Participants)
Count of Participants [Participants]	60 53.1%	73 59.3%	133 56.4%
Number of participants with hypertensive disease (Count of Participants)
Count of Participants [Participants]	60 53.1%	62 50.4%	122 51.7%
Number of participants with diabetes in pregnancy (Count of Participants)
Count of Participants [Participants]	20 17.7%	24 19.5%	44 18.6%
Body Mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	38.9 (10.3)	37.7 (9.6)	38.3 (10.0)
Bishop score (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	3	3	3

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Need for Cesarean Delivery
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	51 45.1%	53 43.1%

2. Secondary Outcome

Title	Indication for Cesarean Delivery
Description	Categories of Indications for Cesarean Delivery: = Cephalopelvic disproportion = Failed induction/Failure to progress = Cord prolapse = Non-reassuring fetal tracing = Malpresentation = Placental abruption = Other
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

Only 51 in the Combined arm and 53 in the single arm delivered by cesarean.

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	51	53
Arrest disorders	31 27.4%	28 22.8%
Nonreassuring fetal heart rate	13 11.5%	18 14.6%
Other	7 6.2%	7 5.7%

3. Secondary Outcome

Title	Induction-to-delivery Interval in Hours
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Mean (Standard Deviation) [hours]	24.8 (13.8)	24.5 (14.0)

4. Secondary Outcome

Title	Number of Participants With a Need for Oxytocin Augmentation
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	89 78.8%	103 83.7%

5. Secondary Outcome

Title	Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities
Description	Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window.
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	10 8.8%	20 16.3%

6. Secondary Outcome

Title	Number of Participants With Clinical Chorioamnionitis
Description	Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid.
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	1 0.9%	1 0.8%

7. Secondary Outcome

Title	Number of Participants With a Need for Operative Vaginal Delivery
Time Frame	Induction to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	5 4.4%	6 4.9%

8. Secondary Outcome

Title	Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity
Description	Measures of maternal morbidity assessed: Maternal ICU admission Postpartum endometritis Surgical-site infections prior to discharge Venous thromboembolism Need for transfusion Maternal death
Time Frame	Induction to discharge (approximately 5 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Maternal ICU Admission	0 0%	3 2.4%
Postpartum endometritis	3 2.7%	0 0%
Surgical site infection	5 4.4%	1 0.8%

9. Secondary Outcome

Title	Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU)
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	24 21.2%	20 16.3%

10. Secondary Outcome

Title	Number of Newborns With Transient Tachypnea (TTN)
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	5 4.4%	5 4.1%

11. Secondary Outcome

Title	Number of Newborns With Respiratory Distress Syndrome (RDS)
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	5 4.4%	4 3.3%

12. Secondary Outcome

Title	Number of Newborns With Meconium Aspiration Syndrome
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

Data was not collected for this outcome measure.

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	0	0

13. Secondary Outcome

Title	Number of Newborns With Culture-proven Sepsis
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	0 0%	1 0.8%

14. Secondary Outcome

Title	Number of Newborns With Seizures
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Count of Participants [Participants]	0 0%	0 0%

15. Secondary Outcome

Title	Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity
Description	Measures of neonatal morbidity assessed: Apgar score ≤ 7 at 5 mins Umbilical cord potential of hydrogen (pH) < 7.1 Neonatal injury: brachial plexus injury, fracture Perinatal death
Time Frame	From delivery to neonatal discharge (approximately 2 to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol	Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol	These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
Measure Participants	113	123
Apgar score < 7 at 5 minutes	4 3.5%	3 2.4%
cord pH < 7.1	5 4.4%	5 4.1%
any neonatal injury	3 2.7%	3 2.4%

Adverse Events

Time Frame	From time of induction to time of discharge (about 5 days for mothers, and about 3-8 days for infants)
Arm/Group Title	Combined Approach: Foley Balloon + Vaginal Misoprostol		Single Approach: Vaginal Misoprostol Only
Arm/Group Description	These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol		These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol
All Cause Mortality
	Combined Approach: Foley Balloon + Vaginal Misoprostol		Single Approach: Vaginal Misoprostol Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/123 (0%)
Serious Adverse Events
	Combined Approach: Foley Balloon + Vaginal Misoprostol		Single Approach: Vaginal Misoprostol Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Combined Approach: Foley Balloon + Vaginal Misoprostol		Single Approach: Vaginal Misoprostol Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/123 (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.