Abortion, Induced
Conditions
Keywords
Mifepristone, Induced Abortion, Dilation and Evacuation, Cervical preparation, Osmotic dilators
Brief summary
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased total time as two sets of dilators.
Interventions
DRUGMifepristone
200mg Mifepristone orally
Dilapan-S osmostic cervical dilators inserted through the internal os
DRUGMisoprostol
400mcg buccal misoprostol 90 minutes pre-op
1mg digoxin administered intra-amniotically \ 24 hours pre-op
Sponsors
Santa Clara Valley Medical Center
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old * Viable, Singleton pregnancy * Voluntarily seeking abortion between 19 and 24wks gestation * Able to give informed consent and comply with study protocol * Fluent in English or Spanish
Exclusion criteria
* Allergy to misoprostol or mifepristone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Intraoperative Time | Measured as time from speculum insertion to removal |
| Total Procedure Time | Measured at clinic visits and on OR day, over a 3 day period | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Procedure by Blinded Surgeon | Measured Immediately after procedure | Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon. |
| Pain Perceived by Patient | Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) | Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient. |
| Maximum Cervical Dilation | Measured intra-operatively | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure. |
| Adverse Events | Intraoperatively and 2 weeks post operatively | uterine perforation, uterine injury, etc. |
| Overall Patient Experience | Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge | Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience. |
| Adverse Events (EBL) | Intraoperatively | One adverse event: Estimated Blood Loss |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Two Sets of Dilators Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \
24 hours pre-op | 24 |
| Mifepristone Plus One Set of Dilators One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \
24 hours pre-op | 26 |
| Total | 50 |
Baseline characteristics
| Characteristic | Two Sets of Dilators | Mifepristone Plus One Set of Dilators | Total |
|---|---|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 6.5 | 27.7 years STANDARD_DEVIATION 6.7 | 27.7 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment United States | 24 participants | 26 participants | 50 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 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 | — / — | — / — |
| other Total, other adverse events | 3 / 24 | 2 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
Procedure Time
Measured as time from speculum insertion to removal
Time frame: Intraoperative Time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two Sets of Dilators | Procedure Time | 10.9 minutes | Standard Deviation 5.1 |
| Mifepristone Plus One Set of Dilators | Procedure Time | 11.8 minutes | Standard Deviation 5.4 |
Primary
Total Procedure Time
Time frame: Measured at clinic visits and on OR day, over a 3 day period
Population: Data missing for two subjects in Mifepristone plus one set of dilators arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two Sets of Dilators | Total Procedure Time | 165 hours | Standard Deviation 57 |
| Mifepristone Plus One Set of Dilators | Total Procedure Time | 86 hours | Standard Deviation 44 |
Secondary
Adverse Events
uterine perforation, uterine injury, etc.
Time frame: Intraoperatively and 2 weeks post operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Two Sets of Dilators | Adverse Events | Pre-Procedure Delivery | 2 participants |
| Two Sets of Dilators | Adverse Events | Cervical Injury | 0 participants |
| Two Sets of Dilators | Adverse Events | RUpture of Membranes with Subsequent Fever | 1 participants |
| Mifepristone Plus One Set of Dilators | Adverse Events | Pre-Procedure Delivery | 1 participants |
| Mifepristone Plus One Set of Dilators | Adverse Events | Cervical Injury | 1 participants |
| Mifepristone Plus One Set of Dilators | Adverse Events | RUpture of Membranes with Subsequent Fever | 0 participants |
Secondary
Adverse Events (EBL)
One adverse event: Estimated Blood Loss
Time frame: Intraoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Two Sets of Dilators | Adverse Events (EBL) | 57 mL | Standard Deviation 31 |
| Mifepristone Plus One Set of Dilators | Adverse Events (EBL) | 63 mL | Standard Deviation 43 |
Secondary
Ease of Procedure by Blinded Surgeon
Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
Time frame: Measured Immediately after procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Two Sets of Dilators | Ease of Procedure by Blinded Surgeon | 29 units on a scale |
| Mifepristone Plus One Set of Dilators | Ease of Procedure by Blinded Surgeon | 30 units on a scale |
Secondary
Maximum Cervical Dilation
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Time frame: Measured intra-operatively
Population: Data missing for one subject in Mifepristone plus one set of dilators arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Two Sets of Dilators | Maximum Cervical Dilation | Pre-op Cervical Dilation 2 cm | 2 participants |
| Two Sets of Dilators | Maximum Cervical Dilation | Pre-op Cervical Dilation 3 cm | 9 participants |
| Two Sets of Dilators | Maximum Cervical Dilation | Pre-Op Cervical Dilation 4 cm | 8 participants |
| Two Sets of Dilators | Maximum Cervical Dilation | Pre-Op Cervical Dilation 5 cm | 2 participants |
| Mifepristone Plus One Set of Dilators | Maximum Cervical Dilation | Pre-Op Cervical Dilation 5 cm | 1 participants |
| Mifepristone Plus One Set of Dilators | Maximum Cervical Dilation | Pre-op Cervical Dilation 2 cm | 3 participants |
| Mifepristone Plus One Set of Dilators | Maximum Cervical Dilation | Pre-Op Cervical Dilation 4 cm | 5 participants |
| Mifepristone Plus One Set of Dilators | Maximum Cervical Dilation | Pre-op Cervical Dilation 3 cm | 14 participants |
Secondary
Overall Patient Experience
Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
Time frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Two Sets of Dilators | Overall Patient Experience | 72 units on a scale |
| Mifepristone Plus One Set of Dilators | Overall Patient Experience | 79 units on a scale |
Secondary
Pain Perceived by Patient
Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
Time frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Two Sets of Dilators | Pain Perceived by Patient | Subject Pain Pre-Op | 13 units on a scale |
| Two Sets of Dilators | Pain Perceived by Patient | Subject Pain Post-Op | 3 units on a scale |
| Mifepristone Plus One Set of Dilators | Pain Perceived by Patient | Subject Pain Pre-Op | 63 units on a scale |
| Mifepristone Plus One Set of Dilators | Pain Perceived by Patient | Subject Pain Post-Op | 16 units on a scale |