NCT06078501

MisOpRostol Effect on Second Trimester Abortion Blood Loss

Misoprostol Effect on Second Trimester Abortion Blood Loss

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Misoprostol 400mcg buccal	Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
DRUG	Placebo	Placebo buccal administration 2-3 hours prior to procedure

Timeline

• Start date: 2024-02-08
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2023-10-12
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study