MisOpRostol Effect on Second Trimester Abortion Blood Loss

NCT06078501 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 72229
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Loss, Surgical; Second Trimester Abortion

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss

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

  day of procedure (approximately 1 hour)

Secondary Outcomes (10)

• Patient-reported Pain Scale Score

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

• Overall Satisfaction With Care Experience Scale Score

  after procedure (approximately 1 minute to complete survey)

• Number of Participants With Vaginal Bleeding

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

• Number of Participants With Abdominal Pain

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

• Procedure Time

  up to 1 hour

Study Arms (2)

Misoprostol 400mcg buccal

EXPERIMENTAL

Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure

Drug: Misoprostol 400mcg buccal

Placebo

PLACEBO COMPARATOR

Participants will take a placebo buccally 2-3 hours prior to their procedure

Drug: Placebo

Interventions

Misoprostol 400mcg buccal DRUG

Misoprostol 400mcg buccal administration 2-3 hours prior to procedure

Also known as: cytotec

Misoprostol 400mcg buccal

Placebo DRUG

Placebo buccal administration 2-3 hours prior to procedure

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; English or Spanish speaking, able to consent for a research study, literate in English or Spanish.

You may not qualify if:

• known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Early termination led to a small number of participants analyzed.

Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

gynresearch@stanford.edu

650-497-5175

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 12, 2023
• Study Start: February 8, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)