Not provided
Not provided
Not provided
Not provided
Recruitment not feasible for this patient population within study timeframe
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol 400mcg buccal | Experimental | Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure |
|
| Placebo | Placebo Comparator | Participants will take a placebo buccally 2-3 hours prior to their procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol 400mcg buccal | Drug | Misoprostol 400mcg buccal administration 2-3 hours prior to procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day of procedure (approximately 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Pain Scale Score | Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable). | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospital | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol 400mcg Buccal | Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure |
| FG001 | Placebo | Participants take a placebo buccally 2-3 hours prior to their procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol 400mcg Buccal | Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure |
| BG001 | Placebo | Participants take a placebo buccally 2-3 hours prior to their procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | day of procedure (approximately 1 hour) |
|
2 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Misoprostol 400mcg Buccal | Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cramping | Reproductive system and breast disorders | Systematic Assessment |
Early termination led to a small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | 650-497-5175 | gynresearch@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2023 | Jul 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2023 | Jul 10, 2025 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo buccal administration 2-3 hours prior to procedure |
|
Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied). |
| 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. | 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. | during procedure (up to 1 hour), after medication administration |
| Procedure Time | up to 1 hour |
| Physician-rated Ease of Use Scale Score | Ease of use rated from 1 (easiest) to 10 (most difficult) | 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. | during procedure (up to 1 hour) |
| Number of Participants Requiring Manual Dilation | during procedure (up to 1 hour) |
| Physician-rated Satisfaction With Dilation Scale Score | Satisfaction rated from 1 (least satisfied) to 10 (most satisfied) | after procedure (approximately 1 minute to complete survey) |
| Clinician Correctly Guessed Group to Which Participant Was Randomized | after procedure (approximately 1 minute to complete survey) |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patient-reported Pain Scale Score | Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure) |
|
|
|
|
| Secondary | Overall Satisfaction With Care Experience Scale Score | Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied). | Posted | Mean | Standard Deviation | score on a scale | after procedure (approximately 1 minute to complete survey) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | during procedure (up to 1 hour), after medication administration |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | during procedure (up to 1 hour), after medication administration |
|
|
|
|
| Secondary | Procedure Time | Posted | Mean | Standard Deviation | minutes | up to 1 hour |
|
|
|
|
| Secondary | Physician-rated Ease of Use Scale Score | Ease of use rated from 1 (easiest) to 10 (most difficult) | Posted | Median | Inter-Quartile Range | score on a scale | after procedure (approximately 1 minute to complete survey) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | during procedure (up to 1 hour) |
|
|
|
| Secondary | Number of Participants Requiring Manual Dilation | Posted | Count of Participants | Participants | during procedure (up to 1 hour) |
|
|
|
|
| Secondary | Physician-rated Satisfaction With Dilation Scale Score | Satisfaction rated from 1 (least satisfied) to 10 (most satisfied) | Posted | Median | Inter-Quartile Range | score on a scale | after procedure (approximately 1 minute to complete survey) |
|
|
|
|
| Secondary | Clinician Correctly Guessed Group to Which Participant Was Randomized | Posted | Count of Participants | Participants | after procedure (approximately 1 minute to complete survey) |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Placebo | Participants take a placebo buccally 2-3 hours prior to their procedure | 0 | 3 | 0 | 3 | 3 | 3 |
Not provided
Not provided
Not provided
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |