Trial Outcomes & Findings for Cervical Preparation Before Dilation and Evacuation (NCT NCT01751087)

NCT ID: NCT01751087

Last Updated: 2016-02-24

Results Overview

The duration of the D\&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D\&E

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes
• Results posted on: 2016-02-24

Participant Flow

Recruitment period: February 2013-February 2014 Number of recruitment sites: 7 Types of location: medical clinic (3), hospital-based (4)

Participant milestones

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Overall Study STARTED	100	100	100
Overall Study COMPLETED	99	100	99
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Overall Study Withdrawal by Subject	1	0	0
Overall Study Physician Decision	0	0	1

Baseline Characteristics

Cervical Preparation Before Dilation and Evacuation

Baseline characteristics by cohort

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=100 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=100 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2	Total n=300 Participants Total of all reporting groups
Age, Continuous	24.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	25.9 years STANDARD_DEVIATION 5.9 • n=7 Participants	25.3 years STANDARD_DEVIATION 5.8 • n=5 Participants	25.25 years STANDARD_DEVIATION 5.8 • n=4 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	100 Participants n=5 Participants	300 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
Race/Ethnicity, Customized Hispanic or Latina	19 participants n=5 Participants	18 participants n=7 Participants	22 participants n=5 Participants	59 participants n=4 Participants
Race/Ethnicity, Customized African American or black	39 participants n=5 Participants	48 participants n=7 Participants	36 participants n=5 Participants	123 participants n=4 Participants
Race/Ethnicity, Customized White or European American	31 participants n=5 Participants	22 participants n=7 Participants	29 participants n=5 Participants	82 participants n=4 Participants
Race/Ethnicity, Customized Other	11 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	36 participants n=4 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	100 participants n=5 Participants	300 participants n=4 Participants

PRIMARY outcome

Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Population: Arm 1 (dilators-alone): 1 subject excluded \[withdrawn/no intervention\]. Arm 2 (dilators + misoprostol): 2 excluded: \[one expelled, no D\&E, one D\&E not completed on first attempt \& data missing\]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D\&E not completed on first attempt \& data missing\].

The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=98 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=98 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Operative Time	6.27 minutes Standard Deviation 3.5	6.28 minutes Standard Deviation 4.6	5.53 minutes Standard Deviation 2.9

SECONDARY outcome

Timeframe: participants were assessed during cervical dilation process, average time of 1 minute

Population: Arm 1: 1 subject excluded \[withdrawn/no intervention\]. Arm 2: 2 excluded: \[one expelled, no D\&E, one D\&E not completed on first attempt \& data missing\]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D\&E not completed on first attempt \& data missing\]. Additionally missing data for one more subject in Arm 2.

Measured at the time of procedure (immediately before the start of D&E)

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=97 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=98 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Initial Cervical Dilation	2.2 centimeters Standard Deviation 0.5	2.5 centimeters Standard Deviation 0.9	2.4 centimeters Standard Deviation 0.5

SECONDARY outcome

Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Ability to Complete the D&E on the First Attempt	98 participants	98 participants	98 participants

SECONDARY outcome

Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Population: Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D\&E. Arm 3: one subject withdrawn/no intervention

Assessed on Day of procedure. Assessed immediately after completion of D&E

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=98 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Need for Mechanical Dilation	26 participants Interval 17.8 to 35.3	9 participants Interval 3.4 to 14.8	16 participants Interval 8.9 to 23.4

SECONDARY outcome

Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Population: Number of participants in each arm who required additional mechanical dilation

Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=26 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=9 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=16 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Ease of Mechanical Dilation	6 participants	4 participants	1 participants

SECONDARY outcome

Timeframe: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure

Patient having any complication, including hospitalizations transfusions additional unplanned procedures

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Complications From Procedure	10 participants	2 participants	2 participants

SECONDARY outcome

Timeframe: assessed immediately after administration of day 2 medication

chills (any) after Day 2 medication administration

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Chills (Any) After Day 2 Medication Administration	12 participants Interval 5.7 to 18.6	39 participants Interval 29.4 to 48.6	18 participants Interval 10.6 to 25.8

SECONDARY outcome

Timeframe: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days

Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Patient Satisfaction With Cervical Prep	72 participants	80 participants	80 participants

SECONDARY outcome

Timeframe: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes

Population: Data on whether the physician was satisfied with the cervical preparation is available for all participants except: Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D\&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data.

Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.

Outcome measures

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=99 Participants Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=98 Participants Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Physician Satisfaction With Cervical Preparation	71 participants Interval 62.9 to 80.6	78 participants Interval 70.7 to 86.8	85 participants Interval 80.0 to 93.5

Adverse Events

Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Osmotic Dilators + Placebo (Vit c) + Misoprostol

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Osmotic Dilators + Mifepristone + Placebo (Vit B12)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 participants at risk Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 participants at risk Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 participants at risk Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Reproductive system and breast disorders Hospitalization for bleeding	2.0% 2/99 • Number of events 2 • 1 month post-procedure	0.00% 0/100 • 1 month post-procedure	1.0% 1/99 • Number of events 1 • 1 month post-procedure
Reproductive system and breast disorders Hospitalization for bleeding + Hysterectomy	0.00% 0/99 • 1 month post-procedure	1.0% 1/100 • Number of events 1 • 1 month post-procedure	0.00% 0/99 • 1 month post-procedure

Other adverse events

Measure	Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) n=99 participants at risk Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2	Osmotic Dilators + Placebo (Vit c) + Misoprostol n=100 participants at risk Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1	Osmotic Dilators + Mifepristone + Placebo (Vit B12) n=99 participants at risk Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2
Reproductive system and breast disorders uterine re-aspiration	2.0% 2/99 • Number of events 2 • 1 month post-procedure	1.0% 1/100 • Number of events 1 • 1 month post-procedure	1.0% 1/99 • Number of events 1 • 1 month post-procedure
Reproductive system and breast disorders Intrauterine tamponade or cervical stay sutures	3.0% 3/99 • Number of events 3 • 1 month post-procedure	0.00% 0/100 • 1 month post-procedure	0.00% 0/99 • 1 month post-procedure
Reproductive system and breast disorders cervical laceration requiring sutures	3.0% 3/99 • Number of events 3 • 1 month post-procedure	0.00% 0/100 • 1 month post-procedure	0.00% 0/99 • 1 month post-procedure

Additional Information

Principal Investigator

Planned Parenthood League of Massachusetts, Inc.

Phone: 617.616.1600

Results disclosure agreements

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