Misoprostol Effect on Second Trimester Abortion Blood Loss

Study Overview
=================
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.

Official Title
-----------------
Misoprostol Effect on Second Trimester Abortion Blood Loss

Conditions
-----------------
Blood Loss, Surgical, Second Trimester Abortion

Intervention / Treatment
-----------------
* Drug: Misoprostol 400mcg buccal
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol 400mcg buccal<br>Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure | Drug: Misoprostol 400mcg buccal<br>* Misoprostol 400mcg buccal administration 2-3 hours prior to procedure<br>* Other names: cytotec;|
| Placebo Comparator: Placebo<br>Participants will take a placebo bucally 2-3 hours prior to their procedure | Drug: Placebo<br>* Placebo buccal administration 2-3 hours prior to procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantified blood loss | QBL | day of procedure (approximately 1 hour) |