Trial Outcomes & Findings for Comparison of Pre-Induction Cervical Ripening (NCT NCT01390233)
NCT ID: NCT01390233
Last Updated: 2014-05-30
Results Overview
The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Gestational age 26-42 weeks
Results posted on
2014-05-30
Participant Flow
Participant milestones
| Measure |
Urinary Balloon Catheter Only
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device.
|
Prepadil Only
Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina.
|
Combined Urinary Catheter & Prepadil Gel
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
36
|
|
Overall Study
COMPLETED
|
30
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Pre-Induction Cervical Ripening
Baseline characteristics by cohort
| Measure |
Urinary Balloon Catheter Only
n=34 Participants
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device.
|
Prepadil Only
n=31 Participants
Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina.
|
Combined Urinary Catheter & Prepadil Gel
n=36 Participants
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
25 years
n=7 Participants
|
26 years
n=5 Participants
|
25 years
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
36 participants
n=5 Participants
|
101 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Gestational age 26-42 weeksThe primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.
Outcome measures
| Measure |
Urinary Balloon Catheter Only
n=34 Participants
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device.
|
Prepadil Only
n=31 Participants
Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina.
|
Combined Urinary Catheter & Prepadil Gel
n=36 Participants
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
|
|---|---|---|---|
|
Vaginal Delivery
|
20 participants
|
21 participants
|
20 participants
|
Adverse Events
Prepadil Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Urinary Balloon Catheter Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined Urinary Catheter & Prepadil Gel
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prepadil Only
n=31 participants at risk
Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina.
|
Urinary Balloon Catheter Only
n=35 participants at risk
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device.
|
Combined Urinary Catheter & Prepadil Gel
n=36 participants at risk
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Placental Abruption
|
0.00%
0/31 • Entire enrollment period (July 2010 to February 2013)
|
0.00%
0/35 • Entire enrollment period (July 2010 to February 2013)
|
2.8%
1/36 • Number of events 1 • Entire enrollment period (July 2010 to February 2013)
|
Other adverse events
Adverse event data not reported
Additional Information
Meg Hill, MBBS
University of Arizona (Investigator has changed institutions - study completed at University of South Carolina)
Phone: 520 626 6174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place