Blood Loss, Surgical, Second Trimester Abortion
Conditions
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.
Interventions
DRUGMisoprostol 400mcg buccal
Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
DRUGPlacebo
Placebo buccal administration 2-3 hours prior to procedure
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| 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). |
| 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. |
| 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) |
| Clinician Correctly Guessed Group to Which Participant Was Randomized | after procedure (approximately 1 minute to complete survey) | — |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol 400mcg Buccal Participants take 400mcg buccal misoprostol 2-3 hours prior to their procedure | 4 |
| Placebo Participants take a placebo buccally 2-3 hours prior to their procedure | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Placebo | Misoprostol 400mcg Buccal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Chinese | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Indian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Mexican | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
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.
Time frame: day of procedure (approximately 1 hour)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Misoprostol 400mcg Buccal | Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss | 0 Participants |
| Placebo | Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss | 0 Participants |
Secondary
Clinician Correctly Guessed Group to Which Participant Was Randomized
Time frame: after procedure (approximately 1 minute to complete survey)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Misoprostol 400mcg Buccal | Clinician Correctly Guessed Group to Which Participant Was Randomized | 0 Participants |
| Placebo | Clinician Correctly Guessed Group to Which Participant Was Randomized | 0 Participants |
p-value: 1Fisher Exact
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.
Time frame: during procedure (up to 1 hour)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Misoprostol 400mcg Buccal | Number of Participants Estimated Blood Loss >500 ml | 0 Participants |
| Placebo | Number of Participants Estimated Blood Loss >500 ml | 0 Participants |
Secondary
Number of Participants Requiring Manual Dilation
Time frame: during procedure (up to 1 hour)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Misoprostol 400mcg Buccal | Number of Participants Requiring Manual Dilation | 1 Participants |
| Placebo | Number of Participants Requiring Manual Dilation | 1 Participants |
p-value: 1Fisher Exact
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.
Time frame: during procedure (up to 1 hour), after medication administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Misoprostol 400mcg Buccal | Number of Participants With Abdominal Pain | 2 Participants |
| Placebo | Number of Participants With Abdominal Pain | 1 Participants |
p-value: 1Fisher Exact
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.
Time frame: during procedure (up to 1 hour), after medication administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Misoprostol 400mcg Buccal | Number of Participants With Vaginal Bleeding | 3 Participants |
| Placebo | Number of Participants With Vaginal Bleeding | 2 Participants |
p-value: 1Fisher Exact
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Misoprostol 400mcg Buccal | Overall Satisfaction With Care Experience Scale Score | 10 score on a scale | Standard Deviation 0 |
| Placebo | Overall Satisfaction With Care Experience Scale Score | 10 score on a scale | Standard Deviation 0 |
p-value: 0.91Mann-Whitney U test
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Misoprostol 400mcg Buccal | Patient-reported Pain Scale Score | Before medication administration | 5.00 score on a scale | Standard Deviation 2.45 |
| Misoprostol 400mcg Buccal | Patient-reported Pain Scale Score | After medication administration | 4.50 score on a scale | Standard Deviation 4.95 |
| Placebo | Patient-reported Pain Scale Score | Before medication administration | 4.00 score on a scale | Standard Deviation 3.46 |
| Placebo | Patient-reported Pain Scale Score | After medication administration | 4.00 score on a scale | Standard Deviation 3.46 |
p-value: 0.695Mann-Whitney U test
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Misoprostol 400mcg Buccal | Physician-rated Ease of Use Scale Score | 4.50 score on a scale |
| Placebo | Physician-rated Ease of Use Scale Score | 5.50 score on a scale |
p-value: 0.887Mann-Whitney U test
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Misoprostol 400mcg Buccal | Physician-rated Satisfaction With Dilation Scale Score | 6.50 score on a scale |
| Placebo | Physician-rated Satisfaction With Dilation Scale Score | 8.00 score on a scale |
p-value: 1Mann-Whitney U test
Secondary
Procedure Time
Time frame: up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Misoprostol 400mcg Buccal | Procedure Time | 22.25 minutes | Standard Deviation 14.38 |
| Placebo | Procedure Time | 24.00 minutes | Standard Deviation 15.72 |
p-value: 0.887Mann-Whitney U test