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MisOpRostol Effect on Second Trimester Abortion Blood Loss
Recruiting
Trial ID: NCT06078501
Purpose
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.
Official Title
Misoprostol Effect on Second Trimester Abortion Blood Loss
Stanford Investigator(s)
Kate Shaw, MD MS
Associate Professor of Obstetrics and Gynecology
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.
Intervention(s):
drug: Misoprostol 400mcg buccal
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305