MisOpRostol Effect on Second Trimester Abortion Blood Loss

Phase 3

• Conditions: Blood Loss, Surgical; Second Trimester Abortion
• Interventions: Drug: Misoprostol 400mcg buccal; Drug: Placebo

• Registration Number: NCT06078501
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-12
• Status Verified: 2024-02
• Study Start: 2024-02-08
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol 400mcg buccal	Misoprostol 400mcg buccal	Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure
Placebo	Placebo	Participants will take a placebo buccally 2-3 hours prior to their procedure

Primary Outcome Measures

Name	Time	Method
quantified blood loss	day of procedure (approximately 1 hour)	QBL

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Palo Alto, California, United States