MisOpRostol Effect on Second Trimester Abortion Blood Loss (MORESTABL)

Stanford University

Status and phase: Terminated; Phase 3

Conditions: Blood Loss, Surgical; Second Trimester Abortion

Treatments: Drug: Misoprostol 400mcg buccal; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06078501

72229

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups, including a placebo group

Misoprostol 400mcg buccal

Experimental group

Description:

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

Treatment:

Drug: Misoprostol 400mcg buccal

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo