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Slow recruitment compounded by COVID-19
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D&E) procedures.
No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Experimental | Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement |
|
| Placebo | Placebo Comparator | Participants ingest placebo oral medication once 18-24 hours prior to dilator placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone 200 MG | Drug | Ingestion of study medication vs placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Had Placement of Expected Dilators or More | The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more." | At time of 1 hour clinic visit (10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Dilation | Measurement of cervical dilation at time of procedure | At time of ~1 hour scheduled procedure time (1 minute) |
| Number of Participants That Required Mechanical Dilation | A count of the number of participants that required of mechanical dilation at time of procedure |
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Inclusion Criteria:
A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol
Exclusion Criteria:
A. Allergy or known intolerance to mifepristone
B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:
C. Any condition that in the opinion of the investigator could impede study participation or collection of study data
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Department of Obstetrics and Gynecology | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone | Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication |
| FG001 | Placebo | Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone | Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants That Had Placement of Expected Dilators or More | The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more." | Posted | Count of Participants | Participants | At time of 1 hour clinic visit (10 minutes) |
|
3 days
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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 | Mifepristone | Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement Mifepristone 200 MG: Ingestion of study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elective withdrawal of participant after study medication ingestion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suji Uhm, MD, MPH | University of Pittsburgh | 412-641-4590 | uhms@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Mar 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo Oral Tablet |
| Drug |
Ingestion of study medication vs placebo |
|
| At time of ~1 hour scheduled procedure time (10 minute) |
| Pain Dilator Placement Using Visual Analog Scale | Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of "no pain" at 0 cm and "worst pain in your life" at 10 cm. Higher scores indicate worse outcome. | At time of 1 hour clinic visit (10 minutes) |
| Provider Assessment of Procedure as "Very Easy" or "Easy" | Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as "Very Easy" or "Easy" (Survey response based on Likert scale: "Very Easy," "Easy," "Moderate," "Difficult," "Very Difficult") | At time of ~1 hour scheduled procedure time |
| Number of Participants That Experienced Complications | Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries | At time of ~1 hour scheduled procedure time (0-30 minute) |
| Number of Participants That Required Mechanical Dilation | Number of participants that required mechanical dilation at time of procedure | At time of ~1 hour scheduled procedure time |
Participants ingest placebo oral medication once 18-24 hours prior to dilator placement
Placebo Oral Tablet: Ingestion of placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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| Obstetrical history | Count of Participants | Participants |
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| Gestational age | Count of Participants | Participants |
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| History of cervical procedures | Count of Participants | Participants |
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| Education - high school diploma or less | Count of Participants | Participants |
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| Married, current | Count of Participants | Participants |
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| OG001 | Placebo | Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo |
|
|
| Secondary | Cervical Dilation | Measurement of cervical dilation at time of procedure | Posted | Median | Inter-Quartile Range | cm | At time of ~1 hour scheduled procedure time (1 minute) |
|
|
|
| Secondary | Number of Participants That Required Mechanical Dilation | A count of the number of participants that required of mechanical dilation at time of procedure | Posted | Count of Participants | Participants | At time of ~1 hour scheduled procedure time (10 minute) |
|
|
|
| Secondary | Pain Dilator Placement Using Visual Analog Scale | Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of "no pain" at 0 cm and "worst pain in your life" at 10 cm. Higher scores indicate worse outcome. | Posted | Median | Inter-Quartile Range | cm | At time of 1 hour clinic visit (10 minutes) |
|
|
|
| Secondary | Provider Assessment of Procedure as "Very Easy" or "Easy" | Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as "Very Easy" or "Easy" (Survey response based on Likert scale: "Very Easy," "Easy," "Moderate," "Difficult," "Very Difficult") | Posted | Count of Participants | Participants | At time of ~1 hour scheduled procedure time |
|
|
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| Secondary | Number of Participants That Experienced Complications | Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries | Posted | Count of Participants | Participants | At time of ~1 hour scheduled procedure time (0-30 minute) |
|
|
|
| Secondary | Number of Participants That Required Mechanical Dilation | Number of participants that required mechanical dilation at time of procedure | Posted | Count of Participants | Participants | At time of ~1 hour scheduled procedure time |
|
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | Participants ingest placebo oral medication once 18-24 hours prior to dilator placement Placebo Oral Tablet: Ingestion of placebo | 0 | 22 | 1 | 22 | 0 | 22 |
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| D011083 |
| Polycyclic Compounds |