Trial Outcomes & Findings for Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial (NCT NCT02639429)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

236 participants

Primary outcome timeframe

Induction to delivery

Results posted on

2019-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	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. Foley Balloon + Vaginal Misoprostol	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. Vaginal Misoprostol
Overall Study STARTED	113	123
Overall Study COMPLETED	113	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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 n=236 Participants Total of all reporting groups
Age, Continuous	25.3 years STANDARD_DEVIATION 5.8 • n=5 Participants	23.4 years STANDARD_DEVIATION 6.1 • n=7 Participants	24.3 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	123 Participants n=7 Participants	236 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African Amercian	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	68 Participants n=5 Participants	74 Participants n=7 Participants	142 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	113 Participants n=5 Participants	123 Participants n=7 Participants	236 Participants n=5 Participants
Gestational Age	38.7 weeks STANDARD_DEVIATION 5.2 • n=5 Participants	38.6 weeks STANDARD_DEVIATION 5.4 • n=7 Participants	38.6 weeks STANDARD_DEVIATION 5.4 • n=5 Participants
Number of participants who are married	64 Participants n=5 Participants	67 Participants n=7 Participants	131 Participants n=5 Participants
Number of participants who had prenatal care	110 Participants n=5 Participants	121 Participants n=7 Participants	231 Participants n=5 Participants
Number of participants with government subsidized insurance	60 Participants n=5 Participants	73 Participants n=7 Participants	133 Participants n=5 Participants
Number of participants with hypertensive disease	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
Number of participants with diabetes in pregnancy	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Body Mass index	38.9 kg/m^2 STANDARD_DEVIATION 10.3 • n=5 Participants	37.7 kg/m^2 STANDARD_DEVIATION 9.6 • n=7 Participants	38.3 kg/m^2 STANDARD_DEVIATION 10.0 • n=5 Participants
Bishop score	3 units on a scale n=5 Participants	3 units on a scale n=7 Participants	3 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Induction to delivery

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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
Number of Participants With a Need for Cesarean Delivery	51 Participants	53 Participants

SECONDARY outcome

Timeframe: Induction to delivery

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

Categories of Indications for Cesarean Delivery: 1. = Cephalopelvic disproportion 2. = Failed induction/Failure to progress 3. = Cord prolapse 4. = Non-reassuring fetal tracing 5. = Malpresentation 6. = Placental abruption 7. = Other

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=51 Participants 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	Single Approach: Vaginal Misoprostol Only n=53 Participants 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
Indication for Cesarean Delivery Arrest disorders	31 Participants	28 Participants
Indication for Cesarean Delivery Nonreassuring fetal heart rate	13 Participants	18 Participants
Indication for Cesarean Delivery Other	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Induction to delivery

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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
Induction-to-delivery Interval in Hours	24.8 hours Standard Deviation 13.8	24.5 hours Standard Deviation 14.0

SECONDARY outcome

Timeframe: Induction to delivery

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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
Number of Participants With a Need for Oxytocin Augmentation	89 Participants	103 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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
Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities	10 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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
Number of Participants With Clinical Chorioamnionitis	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Induction to delivery

Outcome measures

Outcome measures
Measure	Combined Approach: Foley Balloon + Vaginal Misoprostol n=113 Participants 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	Single Approach: Vaginal Misoprostol Only n=123 Participants 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
Number of Participants With a Need for Operative Vaginal Delivery	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 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