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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
7
Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
Placebo buccal administration 2-3 hours prior to procedure
Stanford University Hospital
Palo Alto, California, United States
Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss
Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.
Time frame: day of procedure (approximately 1 hour)
Patient-reported Pain Scale Score
Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable).
Time frame: Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure)
Overall Satisfaction With Care Experience Scale Score
Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied).
Time frame: after procedure (approximately 1 minute to complete survey)
Number of Participants With Vaginal Bleeding
Vaginal bleeding is an anticipated part of the procedure and is not always considered to be an adverse event.
Time frame: during procedure (up to 1 hour), after medication administration
Number of Participants With Abdominal Pain
Abdominal pain is an anticipated part of the procedure and is not always considered to be an adverse event.
Time frame: during procedure (up to 1 hour), after medication administration
Procedure Time
Time frame: up to 1 hour
Physician-rated Ease of Use Scale Score
Ease of use rated from 1 (easiest) to 10 (most difficult)
Time frame: after procedure (approximately 1 minute to complete survey)
Number of Participants Estimated Blood Loss >500 ml
Estimated Blood Loss calculated by subjective visual estimate based on visible blood on instruments, drapes, and suction container contents.
Time frame: during procedure (up to 1 hour)
Number of Participants Requiring Manual Dilation
Time frame: during procedure (up to 1 hour)
Physician-rated Satisfaction With Dilation Scale Score
Satisfaction rated from 1 (least satisfied) to 10 (most satisfied)
Time frame: after procedure (approximately 1 minute to complete survey)
Clinician Correctly Guessed Group to Which Participant Was Randomized
Time frame: after procedure (approximately 1 minute to complete survey)
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