MisOpRostol Effect on Second Trimester Abortion Blood Loss (MORESTABL)

Misoprostol Effect on Second Trimester Abortion Blood Loss

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.

Study Overview

• Status: Terminated
• Conditions: Blood Loss, Surgical; Second Trimester Abortion
• Intervention / Treatment: Drug: Misoprostol 400mcg buccal; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Misoprostol 400mcg buccal; Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure	Drug: Misoprostol 400mcg buccal; Misoprostol 400mcg buccal administration 2-3 hours prior to procedure; Other Names: cytotec
Placebo Comparator: Placebo; Participants will take a placebo buccally 2-3 hours prior to their procedure	Drug: Placebo; Placebo buccal administration 2-3 hours prior to procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Pain Scale Score	Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable).	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	Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied).	after procedure (approximately 1 minute to complete survey)
Number of Participants With Vaginal Bleeding	Vaginal bleeding is an anticipated part of the procedure and is not always considered to be an adverse event.	during procedure (up to 1 hour), after medication administration
Number of Participants With Abdominal Pain	Abdominal pain is an anticipated part of the procedure and is not always considered to be an adverse event.	during procedure (up to 1 hour), after medication administration
Procedure Time		up to 1 hour
Physician-rated Ease of Use Scale Score	Ease of use rated from 1 (easiest) to 10 (most difficult)	after procedure (approximately 1 minute to complete survey)
Number of Participants Estimated Blood Loss >500 ml	Estimated Blood Loss calculated by subjective visual estimate based on visible blood on instruments, drapes, and suction container contents.	during procedure (up to 1 hour)
Number of Participants Requiring Manual Dilation		during procedure (up to 1 hour)
Physician-rated Satisfaction With Dilation Scale Score	Satisfaction rated from 1 (least satisfied) to 10 (most satisfied)	after procedure (approximately 1 minute to complete survey)
Clinician Correctly Guessed Group to Which Participant Was Randomized		after procedure (approximately 1 minute to complete survey)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Kate A Shaw, MD MS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Gastrointestinal Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Oxytocics; Anti-Ulcer Agents; Misoprostol
• Other Study ID Numbers: 72229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No