Trial Outcomes & Findings for MisOpRostol Effect on Second Trimester Abortion Blood Loss (NCT NCT06078501)

NCT ID: NCT06078501

Last Updated: 2025-08-24

Results Overview

Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: day of procedure (approximately 1 hour)
• Results posted on: 2025-08-24

Participant Flow

Participant milestones

Measure	Misoprostol 400mcg Buccal Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo Participants take a placebo buccally 2-3 hours prior to their procedure
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MisOpRostol Effect on Second Trimester Abortion Blood Loss

Baseline characteristics by cohort

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Mexican	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: day of procedure (approximately 1 hour)

Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure)

Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable).

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Patient-reported Pain Scale Score Before medication administration	5.00 score on a scale Standard Deviation 2.45	4.00 score on a scale Standard Deviation 3.46
Patient-reported Pain Scale Score After medication administration	4.50 score on a scale Standard Deviation 4.95	4.00 score on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: after procedure (approximately 1 minute to complete survey)

Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied).

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Overall Satisfaction With Care Experience Scale Score	10 score on a scale Standard Deviation 0	10 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: during procedure (up to 1 hour), after medication administration

Vaginal bleeding is an anticipated part of the procedure and is not always considered to be an adverse event.

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Number of Participants With Vaginal Bleeding	3 Participants	2 Participants

SECONDARY outcome

Timeframe: during procedure (up to 1 hour), after medication administration

Abdominal pain is an anticipated part of the procedure and is not always considered to be an adverse event.

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Number of Participants With Abdominal Pain	2 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 1 hour

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Procedure Time	22.25 minutes Standard Deviation 14.38	24.00 minutes Standard Deviation 15.72

SECONDARY outcome

Timeframe: after procedure (approximately 1 minute to complete survey)

Ease of use rated from 1 (easiest) to 10 (most difficult)

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Physician-rated Ease of Use Scale Score	4.50 score on a scale Interval 3.25 to 5.75	5.50 score on a scale Interval 4.75 to 6.25

SECONDARY outcome

Timeframe: during procedure (up to 1 hour)

Estimated Blood Loss calculated by subjective visual estimate based on visible blood on instruments, drapes, and suction container contents.

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Number of Participants Estimated Blood Loss >500 ml	0 Participants	0 Participants

SECONDARY outcome

Timeframe: during procedure (up to 1 hour)

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Number of Participants Requiring Manual Dilation	1 Participants	1 Participants

SECONDARY outcome

Timeframe: after procedure (approximately 1 minute to complete survey)

Satisfaction rated from 1 (least satisfied) to 10 (most satisfied)

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Physician-rated Satisfaction With Dilation Scale Score	6.50 score on a scale Interval 5.25 to 7.75	8.00 score on a scale Interval 8.0 to 8.0

SECONDARY outcome

Timeframe: after procedure (approximately 1 minute to complete survey)

Outcome measures

Measure	Misoprostol 400mcg Buccal n=4 Participants Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 Participants Participants take a placebo buccally 2-3 hours prior to their procedure
Clinician Correctly Guessed Group to Which Participant Was Randomized	0 Participants	0 Participants

Adverse Events

Misoprostol 400mcg Buccal

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

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 400mcg Buccal n=4 participants at risk Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Placebo n=3 participants at risk Participants take a placebo buccally 2-3 hours prior to their procedure
Reproductive system and breast disorders Cramping	100.0% 4/4 • Number of events 9 • 2 days	100.0% 3/3 • Number of events 5 • 2 days

Additional Information

Principal Investigator

Stanford University

Phone: 650-497-5175

Email: gynresearch@stanford.edu

Results disclosure agreements

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