NCT06078501: MORESTABL

MisOpRostol Effect on Second Trimester Abortion Blood Loss

Terminated Phase 3 Results posted Last updated 24 August 2025

What this trial tests

Phase 3 trial testing Misoprostol 400mcg buccal in Blood Loss, Surgical in 7 participants. Terminated before completion.

Timeline

8 February 2024

Primary endpoint
12 July 2024

12 July 2024

Quick facts

Lead sponsor	Stanford University
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	7
Start date	8 February 2024
Primary completion	12 July 2024
Estimated completion	12 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Misoprostol 400mcg buccal — full drug profile →
• Placebo

Conditions studied

• Blood Loss, Surgical — all drugs for Blood Loss, Surgical →
• Second Trimester Abortion — all drugs for Second Trimester Abortion →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Blood Loss, Surgical or Second Trimester Abortion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss Primary · 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.

Group	Value	95% CI
Misoprostol 400mcg Buccal	0
Placebo	0

Patient-reported Pain Scale Score Secondary · 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).

Before medication administration

Group	Value	95% CI
Misoprostol 400mcg Buccal	5.00	± 2.45
Placebo	4.00	± 3.46

After medication administration

Group	Value	95% CI
Misoprostol 400mcg Buccal	4.50	± 4.95
Placebo	4.00	± 3.46

Overall Satisfaction With Care Experience Scale Score Secondary · after procedure (approximately 1 minute to complete survey)

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

Group	Value	95% CI
Misoprostol 400mcg Buccal	10	± 0
Placebo	10	± 0

Number of Participants With Vaginal Bleeding Secondary · 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.

Group	Value	95% CI
Misoprostol 400mcg Buccal	3
Placebo	2

Number of Participants With Abdominal Pain Secondary · 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.

Group	Value	95% CI
Misoprostol 400mcg Buccal	2
Placebo	1

Procedure Time Secondary · up to 1 hour

Group	Value	95% CI
Misoprostol 400mcg Buccal	22.25	± 14.38
Placebo	24.00	± 15.72

Physician-rated Ease of Use Scale Score Secondary · after procedure (approximately 1 minute to complete survey)

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

Group	Value	95% CI
Misoprostol 400mcg Buccal	4.50	3.25 – 5.75
Placebo	5.50	4.75 – 6.25

Number of Participants Estimated Blood Loss >500 ml Secondary · 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.

Group	Value	95% CI
Misoprostol 400mcg Buccal	0
Placebo	0

Number of Participants Requiring Manual Dilation Secondary · during procedure (up to 1 hour)

Group	Value	95% CI
Misoprostol 400mcg Buccal	1
Placebo	1

Physician-rated Satisfaction With Dilation Scale Score Secondary · after procedure (approximately 1 minute to complete survey)

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

Group	Value	95% CI
Misoprostol 400mcg Buccal	6.50	5.25 – 7.75
Placebo	8.00	8.00 – 8.00

Clinician Correctly Guessed Group to Which Participant Was Randomized Secondary · after procedure (approximately 1 minute to complete survey)

Group	Value	95% CI
Misoprostol 400mcg Buccal	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Misoprostol 400mcg Buccal

Serious: 0/4 (0%)

Deaths: 0/4

Placebo

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (1 terms — click to expand)

Reaction	System	Misoprostol 400mcg Buccal	Placebo
Cramping	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT06078501 adverse events section.

Sponsor's own description

Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described.

We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.