Trial Outcomes & Findings for Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks (NCT NCT01615731)
NCT ID: NCT01615731
Last Updated: 2024-02-13
Results Overview
Measured as time from speculum insertion to removal
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Intraoperative Time
Results posted on
2024-02-13
Participant Flow
Participant milestones
| Measure |
Two Sets of Dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
Baseline characteristics by cohort
| Measure |
Two Sets of Dilators
n=24 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=26 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative TimeMeasured as time from speculum insertion to removal
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=24 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Procedure Time
|
10.9 minutes
Standard Deviation 5.1
|
11.8 minutes
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: Measured at clinic visits and on OR day, over a 3 day periodPopulation: Data missing for two subjects in "Mifepristone plus one set of dilators" arm.
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=22 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Total Procedure Time
|
165 hours
Standard Deviation 57
|
86 hours
Standard Deviation 44
|
SECONDARY outcome
Timeframe: Measured intra-operativelyPopulation: Data missing for one subject in "Mifepristone plus one set of dilators" arm.
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=23 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Maximum Cervical Dilation
Pre-op Cervical Dilation 2 cm
|
2 participants
|
3 participants
|
|
Maximum Cervical Dilation
Pre-op Cervical Dilation 3 cm
|
9 participants
|
14 participants
|
|
Maximum Cervical Dilation
Pre-Op Cervical Dilation 4 cm
|
8 participants
|
5 participants
|
|
Maximum Cervical Dilation
Pre-Op Cervical Dilation 5 cm
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: IntraoperativelyOne adverse event: Estimated Blood Loss
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=24 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Adverse Events (EBL)
|
57 mL
Standard Deviation 31
|
63 mL
Standard Deviation 43
|
SECONDARY outcome
Timeframe: Measured Immediately after procedureUsed a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=24 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Ease of Procedure by Blinded Surgeon
|
29 units on a scale
Interval 23.0 to 52.0
|
30 units on a scale
Interval 18.0 to 49.0
|
SECONDARY outcome
Timeframe: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=24 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Pain Perceived by Patient
Subject Pain Pre-Op
|
13 units on a scale
Interval 7.0 to 34.0
|
63 units on a scale
Interval 16.0 to 78.0
|
|
Pain Perceived by Patient
Subject Pain Post-Op
|
3 units on a scale
Interval 1.0 to 32.0
|
16 units on a scale
Interval 6.0 to 29.0
|
SECONDARY outcome
Timeframe: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to dischargeUsed a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=24 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Overall Patient Experience
|
72 units on a scale
Interval 66.0 to 91.0
|
79 units on a scale
Interval 67.0 to 88.0
|
SECONDARY outcome
Timeframe: Intraoperatively and 2 weeks post operativelyuterine perforation, uterine injury, etc.
Outcome measures
| Measure |
Two Sets of Dilators
n=21 Participants
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=24 Participants
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Adverse Events
Pre-Procedure Delivery
|
2 participants
|
1 participants
|
|
Adverse Events
Cervical Injury
|
0 participants
|
1 participants
|
|
Adverse Events
RUpture of Membranes with Subsequent Fever
|
1 participants
|
0 participants
|
Adverse Events
Two Sets of Dilators
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Mifepristone Plus One Set of Dilators
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Two Sets of Dilators
n=24 participants at risk
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
Mifepristone Plus One Set of Dilators
n=26 participants at risk
One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pre-Procedure Delivery
|
8.3%
2/24
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Cervical Injury
|
0.00%
0/24
|
3.8%
1/26
|
|
Pregnancy, puerperium and perinatal conditions
Rupture of Membranes with Subsequent Fever
|
4.2%
1/24
|
0.00%
0/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place