Trial Outcomes & Findings for Cervical Ripening in Postmenopausal Women (NCT NCT02534883)

NCT ID: NCT02534883

Last Updated: 2018-07-12

Results Overview

To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: At time of surgery/cervical dilation
• Results posted on: 2018-07-12

Participant Flow

Participant milestones

Measure	Misoprostol Group Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol). Misoprostol: To be placed vaginally	Placebo Group Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery. Placebo: To be placed vaginally
Overall Study STARTED	8	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	Misoprostol Group Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol). Misoprostol: To be placed vaginally	Placebo Group Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery. Placebo: To be placed vaginally
Overall Study Early Termination	8	3

Baseline Characteristics

11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.

Baseline characteristics by cohort

Measure	Misoprostol Group n=8 Participants Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol). Misoprostol: To be placed vaginally Baseline characteristics not compiled because of early termination.	Placebo Group n=3 Participants Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery. Placebo: To be placed vaginally Baseline characteristics not compiled because of early termination.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	0 Participants n=3 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	0 Participants n=10 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.
Age, Categorical Between 18 and 65 years	4 Participants n=7 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	2 Participants n=3 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	6 Participants n=10 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.
Age, Categorical >=65 years	3 Participants n=7 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	1 Participants n=3 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	4 Participants n=10 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.
Age, Continuous	62.3 years STANDARD_DEVIATION 5.2 • n=7 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	58.7 years STANDARD_DEVIATION 6.1 • n=3 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.	61.2 years STANDARD_DEVIATION 5.5 • n=10 Participants • 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants.
Sex: Female, Male Female	8 Participants n=8 Participants	3 Participants n=3 Participants	11 Participants n=11 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	0 Participants n=3 Participants	0 Participants n=11 Participants
Region of Enrollment United States	8 participants n=8 Participants	3 participants n=3 Participants	11 participants n=11 Participants

PRIMARY outcome

Timeframe: At time of surgery/cervical dilation

Population: Outcome measures presented below.

To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.

Outcome measures

Measure	Group 1 n=7 Participants Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Misoprostol: To be place vaginally	Group 2 n=3 Participants Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally
Efficacy (Cervical Ripening)	1.9 minutes Standard Deviation 1.1	1.4 minutes Standard Deviation .4

SECONDARY outcome

Timeframe: At time of surgery/cervical dilation

Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects

Outcome measures

Measure	Group 1 n=7 side effects Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Misoprostol: To be place vaginally	Group 2 n=7 side effects Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally
Number of Recorded Side Effects.	0.6 number of side effects out of seven Standard Deviation 0.1	0.6 number of side effects out of seven Standard Deviation 0.3

SECONDARY outcome

Timeframe: At time of procedure.

Time from beginning of cervical dilation to completion of cervical dilation.

Outcome measures

Measure	Group 1 n=7 Participants Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Misoprostol: To be place vaginally	Group 2 n=3 Participants Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally
Dilation Time in Minutes	1.9 minutes Standard Deviation 1.1	1.4 minutes Standard Deviation .4

SECONDARY outcome

Timeframe: At time of procedure.

The largest cervical dilator that could be passed through the internal cervical os.

Outcome measures

Measure	Group 1 n=7 Participants Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Misoprostol: To be place vaginally	Group 2 n=3 Participants Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally
Maximum Dilator Size	10.3 millimeters Standard Deviation 4.8	6 millimeters Standard Deviation 0

SECONDARY outcome

Timeframe: At time of procedure.

Count of complications at time of surgery.

Outcome measures

Measure	Group 1 n=7 Participants Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Misoprostol: To be place vaginally	Group 2 n=3 Participants Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally
Number of Complications	0.1 complications Standard Deviation 0.4	0 complications Standard Deviation 0

SECONDARY outcome

Timeframe: At time of procedure.

Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being "normal."

Outcome measures

Measure	Group 1 n=7 Participants Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Misoprostol: To be place vaginally	Group 2 n=3 Participants Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally
Resistance Score	2.9 units on a scale Standard Deviation 2	2.7 units on a scale Standard Deviation 0.6

Adverse Events

Misoprostol Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 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

Donald Gregory Ward, MD

St. Louis University

Phone: 314-781-1505

Email: dgreg.ward@health.slu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place