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| ID | Type | Description | Link |
|---|---|---|---|
| PF-108666 | Other Grant/Funding Number | Packard Foundation |
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| Name | Class |
|---|---|
| Santa Clara Valley Medical Center | OTHER |
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This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilapan-Placebo | Placebo Comparator | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. |
|
| Dilapan-Mifepristone | Active Comparator | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. |
|
| Mifepristone | Experimental | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hygroscopic cervical dilators | Other | Dilapan-S osmotic cervical dilators inserted through the internal os. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Measured as time from speculum insertion to removal | Intraoperative Time, Collected immediately within procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Uterine perforation | Intraoperatively and 2 weeks post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States | ||
| Stanford University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dilapan-Placebo | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation |
| FG001 | Dilapan-Mifepristone | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally |
| FG002 | Mifepristone | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dilapan-Placebo | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation |
| 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 | Median | Full Range | minutes | Intraoperative Time, Collected immediately within procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dilapan-Placebo | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine Perforation | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical Laceration | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | 650-497-5175 | gynresearch@stanford.edu |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Misoprostol | Drug | 400 mcg buccal misoprostol 90 pre-op |
|
| Intra-amniotic digoxin | Drug | 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation |
|
| Mifepristone | Drug | 200 mcg Mifepristone orally |
|
|
| Stanford |
| California |
| 94305 |
| United States |
| BG001 | Dilapan-Mifepristone | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally |
| BG002 | Mifepristone | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dilapan-Mifepristone |
The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally |
| OG002 | Mifepristone | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally |
|
|
| Secondary | Adverse Events | Uterine perforation | Posted | Count of Participants | Participants | Intraoperatively and 2 weeks post operatively |
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Dilapan-Mifepristone | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally | 1 | 27 | 0 | 27 |
| EG002 | Mifepristone | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Misoprostol: 400 mcg buccal misoprostol 90 pre-op Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation Mifepristone: 200 mcg Mifepristone orally | 2 | 27 | 5 | 27 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |