Trial Outcomes & Findings for Misoprostol Versus Dilapan-S for Cervical Preparation (NCT NCT00835731)

NCT ID: NCT00835731

Last Updated: 2017-10-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 125 participants
• Primary outcome timeframe: 3-4 hours after placement of ripening agent
• Results posted on: 2017-10-23

Participant Flow

Dates of recruitment period: January 2009 - December 2011 We recruited English- or Spanish-speaking women who were in good health, at least 18 years old, and between 12 weeks 0 days and 15 weeks 0 days gestation by ultrasound examination, seeking outpatient pregnancy termination at Planned Parenthood League of MA.

Patients were recruited for study participation on the day of their pregnancy termination procedure. All study procedures occurred on the day that the patient was enrolled.

Participant milestones

Measure	Misoprostol 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Overall Study STARTED	64	61
Overall Study COMPLETED	62	60
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Misoprostol 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	1

Baseline Characteristics

Misoprostol Versus Dilapan-S for Cervical Preparation

Baseline characteristics by cohort

Measure	Misoprostol n=64 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=61 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E	Total n=125 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	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.1 years STANDARD_DEVIATION 5.5 • n=5 Participants	24.0 years STANDARD_DEVIATION 5.0 • n=7 Participants	24.0 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	61 Participants n=7 Participants	125 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: 3-4 hours after placement of ripening agent

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Cervical Dilation in Women Following Exposure to Either Ripening Agent	32.1 mm Standard Deviation 6.0	33.9 mm Standard Deviation 4.7

SECONDARY outcome

Timeframe: 3-4 hours after placement of ripening agent

Scale:

None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report None needed (score of 0)	3 Participants	3 Participants
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report Very-somewhat easy (score of 1-2)	29 Participants	27 Participants
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report Moderate (score of 3)	12 Participants	24 Participants
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report Somewhat-very difficult (score of 4-5)	18 Participants	6 Participants

SECONDARY outcome

Timeframe: 3-4 hours after placement of ripening agent

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Procedure Time for Dilation and Evacuation	2.8 minutes Interval 2.0 to 3.8	3.0 minutes Interval 2.2 to 3.9

SECONDARY outcome

Timeframe: 3-4 hours after placement of ripening agent

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt	62 participants	60 participants

SECONDARY outcome

Timeframe: 3-4 hours after placement of ripening agent

Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:

0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain

Higher values represent a worse outcome.

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Subject Pain During Ripening	1 Scores on a scale Interval 1.0 to 3.0	1 Scores on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 3-4 hours after placement of ripening agent

Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:

0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain

Higher values represent a worse outcome.

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Subject Pain During Dilation and Evacuation	3 Scores on a scale Interval 1.0 to 4.0	3 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 5 hours after placement of ripening agent

Scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied

Outcome measures

Measure	Misoprostol n=62 Participants 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 Participants Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Women's Satisfaction With Cervical Ripening Method	4 units on a scale Interval 3.0 to 5.0	4 units on a scale Interval 4.0 to 5.0

Adverse Events

Misoprostol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Synthetic Osmotic Dilator

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Misoprostol n=62 participants at risk 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E	Synthetic Osmotic Dilator n=60 participants at risk Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
Reproductive system and breast disorders Same-day re-evacuation	3.2% 2/62 • Number of events 2	3.3% 2/60 • Number of events 2
Reproductive system and breast disorders Hemorrhage	0.00% 0/62	1.7% 1/60 • Number of events 1
Reproductive system and breast disorders Cervical laceration	1.6% 1/62 • Number of events 1	0.00% 0/60

Additional Information

Principal Investigator

Planned Parenthood League of Massachusetts

Phone: 6176161600

Results disclosure agreements

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