Trial Outcomes & Findings for Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services (NCT NCT01862991)

NCT ID: NCT01862991

Last Updated: 2024-02-14

Results Overview

Measured as time from speculum insertion to removal

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Intraoperative Time, Collected immediately within procedure
• Results posted on: 2024-02-14

Participant Flow

Participant milestones

Measure	Dilapan-Placebo The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally
Overall Study STARTED	24	28	28
Overall Study COMPLETED	21	27	27
Overall Study NOT COMPLETED	3	1	1

Reasons for withdrawal

Measure	Dilapan-Placebo The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally
Overall Study Lost to Follow-up	2	1	1
Overall Study Protocol Violation	1	0	0

Baseline Characteristics

Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

Baseline characteristics by cohort

Measure	Dilapan-Placebo n=21 Participants The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone n=27 Participants The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone n=27 Participants The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Total n=75 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 7 • n=5 Participants	27.5 years STANDARD_DEVIATION 6 • n=7 Participants	27 years STANDARD_DEVIATION 6 • n=5 Participants	28 years STANDARD_DEVIATION 6.5 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants	75 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	21 participants n=5 Participants	27 participants n=7 Participants	27 participants n=5 Participants	75 participants n=4 Participants

PRIMARY outcome

Timeframe: Intraoperative Time, Collected immediately within procedure

Measured as time from speculum insertion to removal

Outcome measures

Measure	Dilapan-Placebo n=21 Participants The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone n=27 Participants The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone n=27 Participants The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally
Procedure Time	13 minutes Interval 6.0 to 26.0	12 minutes Interval 7.0 to 25.0	18.5 minutes Interval 8.0 to 52.0

SECONDARY outcome

Timeframe: Intraoperatively and 2 weeks post operatively

Uterine perforation

Outcome measures

Measure	Dilapan-Placebo n=21 Participants The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone n=27 Participants The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone n=27 Participants The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally
Adverse Events	0 Participants	1 Participants	2 Participants

Adverse Events

Dilapan-Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dilapan-Mifepristone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Mifepristone

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dilapan-Placebo n=21 participants at risk The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone n=27 participants at risk The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone n=27 participants at risk The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally
Reproductive system and breast disorders Uterine Perforation	0.00% 0/21	3.7% 1/27 • Number of events 1	7.4% 2/27 • Number of events 2

Other adverse events

Measure	Dilapan-Placebo n=21 participants at risk The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation	Dilapan-Mifepristone n=27 participants at risk The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally	Mifepristone n=27 participants at risk The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally
Reproductive system and breast disorders Cervical Laceration	4.8% 1/21 • Number of events 1	0.00% 0/27	18.5% 5/27 • Number of events 5

Additional Information

Principal Investigator

Stanford University

Phone: 650-497-5175

Email: gynresearch@stanford.edu

Results disclosure agreements

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