MisOpRostol Effect on Second Trimester Abortion Blood Loss
- Conditions
- Blood Loss, SurgicalSecond Trimester Abortion
- Interventions
- Drug: Placebo
- Registration Number
- NCT06078501
- Lead Sponsor
- Stanford University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- 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.
- known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol 400mcg buccal Misoprostol 400mcg buccal Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure Placebo Placebo Participants will take a placebo buccally 2-3 hours prior to their procedure
- Primary Outcome Measures
Name Time Method Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss day of procedure (approximately 1 hour) Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.
- Secondary Outcome Measures
Name Time Method Patient-reported Pain Scale Score Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure) Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable).
Overall Satisfaction With Care Experience Scale Score after procedure (approximately 1 minute to complete survey) Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied).
Number of Participants With Vaginal Bleeding during procedure (up to 1 hour), after medication administration Vaginal bleeding is an anticipated part of the procedure and is not always considered to be an adverse event.
Number of Participants Requiring Manual Dilation during procedure (up to 1 hour) Physician-rated Satisfaction With Dilation Scale Score after procedure (approximately 1 minute to complete survey) Satisfaction rated from 1 (least satisfied) to 10 (most satisfied)
Number of Participants With Abdominal Pain during procedure (up to 1 hour), after medication administration Abdominal pain is an anticipated part of the procedure and is not always considered to be an adverse event.
Procedure Time up to 1 hour Physician-rated Ease of Use Scale Score after procedure (approximately 1 minute to complete survey) Ease of use rated from 1 (easiest) to 10 (most difficult)
Number of Participants Estimated Blood Loss >500 ml during procedure (up to 1 hour) Estimated Blood Loss calculated by subjective visual estimate based on visible blood on instruments, drapes, and suction container contents.
Clinician Correctly Guessed Group to Which Participant Was Randomized after procedure (approximately 1 minute to complete survey)
Trial Locations
- Locations (1)
Stanford University Hospital
🇺🇸Palo Alto, California, United States
Stanford University Hospital🇺🇸Palo Alto, California, United States