Misoprostol for Second Trimester Abortion Blood Loss

(MORESTABL Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Disqualifiers: Coagulopathy, Morbidly adherent placenta, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kate A Shaw, MD MS

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for pregnant individuals, 18 or older, who are between 18 to nearly 24 weeks into their pregnancy and have decided on an induced abortion. They must be able to understand and consent in English or Spanish. People with blood clotting disorders, suspected placenta complications, multiple pregnancies, current infections, ruptured membranes, or fetal demise at enrollment cannot participate.

Inclusion Criteria

I am pregnant, over 18, planning an induced abortion, and speak English or Spanish.

Exclusion Criteria

Suspected morbidly adherent placenta spectrum

Ruptured membranes

I have a blood clotting disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 400mcg buccal misoprostol or placebo 2-3 hours prior to the procedural abortion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of symptoms and experiences

1-2 weeks

Treatment Details

Interventions

• Misoprostol
• Placebo

Trial Overview The study tests if Misoprostol (a drug used for cervical preparation) given before a second trimester abortion can reduce blood loss compared to a placebo. Participants will either receive the Misoprostol or a placebo without knowing which one they get. The main focus is measuring the amount of blood lost during the procedure.

Participant Groups

Group I: Misoprostol 400mcg buccal Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Misoprostol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cytotec for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in European Union as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in Canada as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+