Trial Outcomes & Findings for Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss (NCT NCT02141555)

Results Overview

The percentage of women who are offered enrollment and accept.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

4 participants

Primary outcome timeframe

One year

Results posted on

2019-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Vaginal Misoprostol Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers. Vaginal Misoprostol: Misoprostol inserted into vagina	Buccal Misoprostol Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes. Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaginal Misoprostol n=2 Participants Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers. Vaginal Misoprostol: Misoprostol inserted into vagina	Buccal Misoprostol n=2 Participants Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes. Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.	Total n=4 Participants Total of all reporting groups
Age, Continuous	40 years n=2 Participants	35 years n=2 Participants	37.5 years n=4 Participants
Sex: Female, Male Female	2 Participants n=2 Participants	2 Participants n=2 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	2 participants n=2 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: One year

The percentage of women who are offered enrollment and accept.

Outcome measures

Outcome measures
Measure	Vaginal Misoprostol n=2 Participants Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers. Vaginal Misoprostol: Misoprostol inserted into vagina	Buccal Misoprostol n=2 Participants Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes. Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Patient Enrollment	2 Participants	2 Participants

SECONDARY outcome

Timeframe: one week

Number of participants with complete abortion without surgical intervention defined as no evidence of a gestational sac on transvaginal ultrasound at the follow up visit.

Outcome measures

Outcome measures
Measure	Vaginal Misoprostol n=2 Participants Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers. Vaginal Misoprostol: Misoprostol inserted into vagina	Buccal Misoprostol n=2 Participants Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes. Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Number of Participants With Complete Abortion	1 Participants	2 Participants

SECONDARY outcome

Timeframe: one week

Written surveys patients will fill out at follow up visit assessing patient's satisfaction with the procedure. "How satisfied were you with your procedure?" The satisfaction scale used was: 1 =Very Satisfied, comfortable, likely to recommend 3= Neutral 5= Very unsatisfied/uncomfortable, unlike to recommend

Outcome measures

Outcome measures
Measure	Vaginal Misoprostol n=2 Participants Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers. Vaginal Misoprostol: Misoprostol inserted into vagina	Buccal Misoprostol n=2 Participants Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes. Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Number of Participants Who Answered 1 or 2 on a Scale of Satisfaction With the Procedure	2 Participants	2 Participants

SECONDARY outcome

Timeframe: one week

Assessment of medication side effects including: nausea, vomiting, headache, fever (over 100.4 F), dizziness, diarrhea, bad taste, dry mouth "Did you experience any of these side effects? If so, how long did they last?" Patients asked on a scale of 0 to 3, where: Side Effect scale: 0 = never 1= less than one day 2 = 1 to 2 days 3 = more than 2 days

Outcome measures

Outcome measures
Measure	Vaginal Misoprostol n=2 Participants Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers. Vaginal Misoprostol: Misoprostol inserted into vagina	Buccal Misoprostol n=2 Participants Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes. Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Number of Participants Reporting 2 or 3 on a Scale of Medication Side Effects	0 Participants	0 Participants

Adverse Events

Vaginal Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buccal Misoprostol

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. Sheila Mody

University of California, San Diego

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place