Trial Outcomes & Findings for Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation (NCT NCT02412618)

Results Overview

Initial cervical dilation as measured by Hegar Dilator accepted with least resistance

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Assessed 4-6 hour following medications at time of D&E procedure

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Mifepristone Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Overall Study STARTED	50	50
Overall Study COMPLETED	48	48
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Mifepristone Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Overall Study Withdrawal by Subject	1	1
Overall Study Expulsion	1	1

Baseline Characteristics

Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone n=50 Participants Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo n=50 Participants Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Misoprostol: Prostaglandin E1 Placebo: Tasteless, odorless, sugar based pill	Total n=100 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	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed 4-6 hour following medications at time of D&E procedure

Initial cervical dilation as measured by Hegar Dilator accepted with least resistance

Outcome measures

Outcome measures
Measure	Mifepristone n=48 Participants Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo n=48 Participants Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Initial Cervical Dilation	11.7 mm Interval 9.0 to 13.0	10.9 mm Interval 9.0 to 13.0

SECONDARY outcome

Timeframe: intraoperative

5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)

Outcome measures

Outcome measures
Measure	Mifepristone n=48 Participants Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo n=48 Participants Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) Nausea	4 units on a scale Interval 1.0 to 5.0	4 units on a scale Interval 1.0 to 5.0
Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) Severe Cramps	4 units on a scale Interval 1.0 to 5.0	4 units on a scale Interval 1.0 to 5.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mifepristone

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

Dr. Frances Casey

VCU Medical Center

Phone: 804-828-7877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place