Trial Outcomes & Findings for Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks (NCT NCT01436279)

Results Overview

Interval from speculum insertion to speculum removal

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Mifepristone + Misoprostol Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure Mifepristone: 200 mg po 20-24 hours prior to the procedure	Osmotic Dilators Placed 20-24 hours prior to procedure osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Overall Study STARTED	30	20
Overall Study COMPLETED	30	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure	Total n=50 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	30 Participants n=5 Participants	20 Participants n=7 Participants	50 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	30 Participants n=5 Participants	20 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

PRIMARY outcome

Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.

Interval from speculum insertion to speculum removal

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Length of Procedure	14 minutes Interval 12.0 to 17.0	13.5 minutes Interval 11.0 to 16.0

SECONDARY outcome

Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Interval from initiation of vacuum aspiration to speculum removal

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Operative Time	9 minutes Interval 7.0 to 12.0	8.5 minutes Interval 7.0 to 9.5

SECONDARY outcome

Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Subject Discomfort Before the Abortion None	18 participants	7 participants
Subject Discomfort Before the Abortion Mild	7 participants	6 participants
Subject Discomfort Before the Abortion Moderate	5 participants	3 participants
Subject Discomfort Before the Abortion Severe	0 participants	4 participants

SECONDARY outcome

Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Amount of pain medication used during the procedure: reported as micrograms of fentanyl

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Pain Medication (Fentanyl) During the Abortion	3.1 mcg Standard Deviation 1.34	2.9 mcg Standard Deviation 1

SECONDARY outcome

Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Amount of pain medication used during the procedure: reported as milligrams of midazolam

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Pain Medication (Midazolam) During the Abortion	104 mg Standard Deviation 31	105 mg Standard Deviation 26

SECONDARY outcome

Timeframe: At time of abortion

Cervical dilation at start of procedure

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Cervical Dilation Achieved	42 mm Standard Deviation 11	56 mm Standard Deviation 5

SECONDARY outcome

Timeframe: After procedure completion

Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Acceptability to Patient	26 Participants	11 Participants

SECONDARY outcome

Timeframe: After completion of procedure

Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."

Outcome measures

Outcome measures
Measure	Mifepristone + Misoprostol n=30 Participants Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Osmotic Dilators n=20 Participants Placed 20-24 hours prior to procedure
Difficulty of Procedure	5 Participants	3 Participants

Adverse Events

Mifepristone + Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Osmotic Dilators

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

Olivera Vragovic

Boston Medical Center

Phone: 617 414 7304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place