Trial Outcomes & Findings for Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks (NCT NCT01636063)
NCT ID: NCT01636063
Last Updated: 2017-05-22
Results Overview
Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
24 to 48 hours after enrollment
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
Mifepristone
Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
|
Misoprostol
Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks
Baseline characteristics by cohort
| Measure |
Mifepristone
n=21 Participants
Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
|
Misoprostol
n=21 Participants
Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 to 48 hours after enrollmentInitial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.
Outcome measures
| Measure |
Mifepristone
n=21 Participants
Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
|
Misoprostol
n=21 Participants
Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure
|
|---|---|---|
|
Initial Cervical Dilation at the Time of Surgical Abortion
|
30.8 French units
Standard Deviation 6.8
|
31.1 French units
Standard Deviation 6.1
|
Adverse Events
Mifepristone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Misoprostol
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