Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Santa Clara Valley Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two sets of dilators | Active Comparator | Two sets of osmotic dilators inserted 1 and 2 days pre-op |
|
| Mifepristone plus one set of dilators | Experimental | One set of dilators plus mifepristone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | 200mg Mifepristone orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Measured as time from speculum insertion to removal | Intraoperative Time |
| Total Procedure Time | Measured at clinic visits and on OR day, over a 3 day period |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Cervical Dilation | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure. | Measured intra-operatively |
| Adverse Events (EBL) | One adverse event: Estimated Blood Loss |
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 |
|---|---|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States | ||
| Stanford University Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Procedure Time | Measured as time from speculum insertion to removal | Posted | Mean | Standard Deviation | minutes | Intraoperative Time |
|
Not provided
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 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-Procedure Delivery | Pregnancy, puerperium and perinatal conditions |
Failure of randomization with respect to assigning similar numbers of nulliparous women to both groups; inaccurate method for measurement of pre-operative cervical dilation; small size of cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | 650-497-5175 | gynresearch@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hygroscopic cervical dilators | Other | Dilapan-S osmostic cervical dilators inserted through the internal os |
|
|
| Misoprostol | Drug | 400mcg buccal misoprostol 90 minutes pre-op |
|
| Intra-amniotic digoxin | Drug | 1mg digoxin administered intra-amniotically ~24 hours pre-op |
|
| Intraoperatively |
| 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. | Measured Immediately after procedure |
| 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. | Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) |
| 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. | Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge |
| Adverse Events | uterine perforation, uterine injury, etc. | Intraoperatively and 2 weeks post operatively |
| Stanford |
| California |
| 94305 |
| United States |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Total Procedure Time | Data missing for two subjects in "Mifepristone plus one set of dilators" arm. | Posted | Mean | Standard Deviation | hours | Measured at clinic visits and on OR day, over a 3 day period |
|
|
|
| Secondary | Maximum Cervical Dilation | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure. | Data missing for one subject in "Mifepristone plus one set of dilators" arm. | Posted | Number | participants | Measured intra-operatively |
|
|
|
| Secondary | Adverse Events (EBL) | One adverse event: Estimated Blood Loss | Posted | Mean | Standard Deviation | mL | Intraoperatively |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Measured Immediately after procedure |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge |
|
|
|
| Secondary | Adverse Events | uterine perforation, uterine injury, etc. | Posted | Number | participants | Intraoperatively and 2 weeks post operatively |
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| EG001 | 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 | 0 | 26 | 2 | 26 |
| Cervical Injury | Injury, poisoning and procedural complications |
|
| Rupture of Membranes with Subsequent Fever | Pregnancy, puerperium and perinatal conditions |
|
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Pre-Op Cervical Dilation 4 cm |
|
| Pre-Op Cervical Dilation 5 cm |
|
| RUpture of Membranes with Subsequent Fever |
|