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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06078501
Other study ID # 72229
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)
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