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Funding changes.
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Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilapan (14wks 0days-15wks, 6days) | Active Comparator | The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure. |
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| Dilapan (16wks 0days-18wks, 6days) | Active Comparator | The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. |
|
| Mifepristone (14wks 0days-15wks, 6days) | Experimental | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. |
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| Mifepristone (16wks 0days-18wks, 6days) | Experimental | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400 mcg buccal 60-90 minutes prior to procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Measured as time from speculum insertion to removal. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Dilation | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure | Baseline |
| Total Procedure Time | All time required by patient (time in clinic for cervical preparation procedures) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Mar Monte | San Jose | California | 95126 | United States |
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| Mifepristone | Drug | 200 mg PO on the day prior to D&E |
|
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| Hygroscopic cervical dilators | Device | osmotic cervical dilators inserted through the internal os |
|
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| Measured at clinic visit and on OR day, over 2 day period |
| Difficulty of Procedure, as reported by clinician | Using Visual Analogue Scale (VAS) | Measured within 5 minutes after procedure |
| Complications/Adverse Events | Estimated blood loss, uterine injury, infection, retained products of conception | Intraoperatively |
| Pain Perceived by Patient | Using Visual Analogue Scale (VAS) | Intraoperatively "Measured during dilator placement" |
| Overall Patient Experience | Using Visual Analogue Scale (VAS) | Measured post-operatively (30 minutes prior to discharge) |
| 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 |
| 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 |
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