Trial Outcomes & Findings for A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor (NCT NCT02566005)
NCT ID: NCT02566005
Last Updated: 2018-03-27
Results Overview
During labor from the start of the induction to the delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Day 1
Results posted on
2018-03-27
Participant Flow
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.
Participant milestones
| Measure |
Misoprostol Group
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.)
|
Misoprostol and Foley Bulb Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
92
|
94
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Misoprostol Group
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.)
|
Misoprostol and Foley Bulb Group
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.
|
|---|---|---|
|
Overall Study
vaginal bleeding
|
0
|
1
|
|
Overall Study
received foley
|
8
|
0
|
|
Overall Study
did not receive foley
|
0
|
1
|
|
Overall Study
labor after randomization
|
0
|
4
|
Baseline Characteristics
Only participants who had a Cesarean delivery
Baseline characteristics by cohort
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 5.9 • n=100 Participants
|
31.8 years
STANDARD_DEVIATION 6.3 • n=100 Participants
|
31.6 years
STANDARD_DEVIATION 6.1 • n=200 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
200 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
BMI
|
31.8 kg/m^2
STANDARD_DEVIATION 6.8 • n=100 Participants
|
31.22 kg/m^2
STANDARD_DEVIATION 5.7 • n=100 Participants
|
31.56 kg/m^2
STANDARD_DEVIATION 6.3 • n=200 Participants
|
|
Parity
Nulliparous
|
74 Participants
n=100 Participants
|
70 Participants
n=100 Participants
|
144 Participants
n=200 Participants
|
|
Parity
Multiparous
|
26 Participants
n=100 Participants
|
30 Participants
n=100 Participants
|
56 Participants
n=200 Participants
|
|
Gestational age at delivery
|
39.4 weeks
STANDARD_DEVIATION 1.4 • n=100 Participants
|
39.6 weeks
STANDARD_DEVIATION 1.3 • n=100 Participants
|
39.4 weeks
STANDARD_DEVIATION 1.4 • n=200 Participants
|
|
Indication for induction
Oligohydramnios/Polyhydramnios
|
21 Participants
n=100 Participants
|
22 Participants
n=100 Participants
|
43 Participants
n=200 Participants
|
|
Indication for induction
Post-EDC
|
21 Participants
n=100 Participants
|
21 Participants
n=100 Participants
|
42 Participants
n=200 Participants
|
|
Indication for induction
Hypertensive disorder
|
28 Participants
n=100 Participants
|
20 Participants
n=100 Participants
|
48 Participants
n=200 Participants
|
|
Indication for induction
Gestational diabetes/Diabetes
|
11 Participants
n=100 Participants
|
11 Participants
n=100 Participants
|
22 Participants
n=200 Participants
|
|
Indication for induction
Advanced maternal age
|
1 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
5 Participants
n=200 Participants
|
|
Indication for induction
Others
|
18 Participants
n=100 Participants
|
22 Participants
n=100 Participants
|
40 Participants
n=200 Participants
|
|
Bishop score at misoprostol placement
|
2.71 units on a scale
STANDARD_DEVIATION 1.78 • n=100 Participants
|
3.17 units on a scale
STANDARD_DEVIATION 1.94 • n=100 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.8 • n=200 Participants
|
|
Mode of delivery
Spontaneous Vaginal Delivery
|
48 Participants
n=100 Participants
|
59 Participants
n=100 Participants
|
107 Participants
n=200 Participants
|
|
Mode of delivery
Forceps Vaginal Delivery
|
2 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
3 Participants
n=200 Participants
|
|
Mode of delivery
Vacuum Vaginal Delivery
|
12 Participants
n=100 Participants
|
10 Participants
n=100 Participants
|
22 Participants
n=200 Participants
|
|
Mode of delivery
Cesarean Delivery
|
38 Participants
n=100 Participants
|
30 Participants
n=100 Participants
|
68 Participants
n=200 Participants
|
|
Indications for cesarean delivery
Non-reassuring Fetal tracing
|
20 Participants
n=38 Participants • Only participants who had a Cesarean delivery
|
19 Participants
n=30 Participants • Only participants who had a Cesarean delivery
|
39 Participants
n=68 Participants • Only participants who had a Cesarean delivery
|
|
Indications for cesarean delivery
Arrest of dilation
|
9 Participants
n=38 Participants • Only participants who had a Cesarean delivery
|
6 Participants
n=30 Participants • Only participants who had a Cesarean delivery
|
15 Participants
n=68 Participants • Only participants who had a Cesarean delivery
|
|
Indications for cesarean delivery
Arrest of descent
|
5 Participants
n=38 Participants • Only participants who had a Cesarean delivery
|
4 Participants
n=30 Participants • Only participants who had a Cesarean delivery
|
9 Participants
n=68 Participants • Only participants who had a Cesarean delivery
|
|
Indications for cesarean delivery
Failed induction of labor
|
3 Participants
n=38 Participants • Only participants who had a Cesarean delivery
|
1 Participants
n=30 Participants • Only participants who had a Cesarean delivery
|
4 Participants
n=68 Participants • Only participants who had a Cesarean delivery
|
|
Indications for cesarean delivery
Others
|
1 Participants
n=38 Participants • Only participants who had a Cesarean delivery
|
0 Participants
n=30 Participants • Only participants who had a Cesarean delivery
|
1 Participants
n=68 Participants • Only participants who had a Cesarean delivery
|
|
Insurance
Private
|
59 Participants
n=100 Participants
|
53 Participants
n=100 Participants
|
112 Participants
n=200 Participants
|
|
Insurance
Service
|
41 Participants
n=100 Participants
|
47 Participants
n=100 Participants
|
88 Participants
n=200 Participants
|
|
Anesthesia
None
|
4 Participants
n=100 Participants
|
6 Participants
n=100 Participants
|
10 Participants
n=200 Participants
|
|
Anesthesia
Neuraxial anesthesia
|
96 Participants
n=100 Participants
|
91 Participants
n=100 Participants
|
187 Participants
n=200 Participants
|
|
Anesthesia
General Anesthesia
|
0 Participants
n=100 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: Day 1During labor from the start of the induction to the delivery
Outcome measures
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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.
|
|---|---|---|
|
The Time Interval From Induction to Delivery: All Participants
|
20.97 hours
Standard Deviation 10.27
|
16.27 hours
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: Day 1Population: for nulliparous participants
Outcome measures
| Measure |
Misoprostol Group
n=74 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=70 Participants
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.
|
|---|---|---|
|
Time (Hours) From Induction to Delivery: Nulliparous
|
22.7 hours
Standard Deviation 10.58
|
18.15 hours
Standard Deviation 7.87
|
PRIMARY outcome
Timeframe: Day 1Population: for nulliparous participants
Outcome measures
| Measure |
Misoprostol Group
n=26 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=30 Participants
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.
|
|---|---|---|
|
Time (Hours) From Induction to Delivery: Multiparous
|
15.99 hours
Standard Deviation 7.4
|
11.89 hours
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Day 1Time (hours) from induction to delivery: Vaginal Delivery (VD)
Outcome measures
| Measure |
Misoprostol Group
n=62 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=70 Participants
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.
|
|---|---|---|
|
Time From Induction to Delivery: VD
|
18.87 hours
Standard Deviation 8
|
15.55 hours
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: Day 1Time (hours) from induction to delivery: Cesarean Delivery (CD)
Outcome measures
| Measure |
Misoprostol Group
n=38 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=30 Participants
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.
|
|---|---|---|
|
Time From Induction to Delivery: CD
|
24.38 hours
Standard Deviation 12.49
|
17.95 hours
Standard Deviation 9.29
|
PRIMARY outcome
Timeframe: day 1Population: those participants on treatment protocol
Outcome measures
| Measure |
Misoprostol Group
n=92 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=94 Participants
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.
|
|---|---|---|
|
Per Treatment Protocol: Time (Hours) From Induction to Delivery
|
20.5109 hours
Standard Deviation 10.09
|
16.6814 hours
Standard Deviation 7.47
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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.
|
|---|---|---|
|
The Time From Induction Until to Active Phase Labor
|
17.43 hours
Standard Deviation 8.6
|
12.81 hours
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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.
|
|---|---|---|
|
The Time From Active Phase to Delivery
|
3.11 hours
Standard Deviation 2.75
|
3.76 hours
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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.
|
|---|---|---|
|
Incidence of Chorioamnionitis
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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.
|
|---|---|---|
|
Incidence of Uterine Tachysystole
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Misoprostol Group
n=100 Participants
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.)
|
Misoprostol and Foley Bulb Group
n=100 Participants
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.
|
|---|---|---|
|
Estimated Blood Loss
|
493.3 ml
Standard Deviation 274
|
490.5 ml
Standard Deviation 304.1
|
Adverse Events
Misoprostol Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Misoprostol and Foley Bulb Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place