MisOpRostol Effect on Second Trimester Abortion Blood Loss

Blood Loss, Surgical Clinical Trial

— MORESTABL  

Official title:

Misoprostol Effect on Second Trimester Abortion Blood Loss

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06078501
• Other study ID #: 72229
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: February 8, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Second Trimester Abortion

Intervention

Drug:
• Misoprostol 400mcg buccal
Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
• Placebo
Placebo buccal administration 2-3 hours prior to procedure

Locations

Country	Name	City	State
United States	Stanford University Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantified blood loss	QBL	day of procedure (approximately 1 hour)