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The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.
Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | Cervical preparation with misoprostol prior to intrauterine device insertion |
|
| Placebo | Placebo Comparator | Cervical preparation with placebo prior to intrauterine device insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). | Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right). | Time of IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS). | Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, M.D., M.P.H | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of the Columbia Willamette | Portland | Oregon | 97206 | United States | ||
| Oregon Health & Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21527040 | Derived | Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104. |
| Label | URL |
|---|---|
| (Women's Health Research Unit website) | View source |
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Women desiring IUD placement who were nulliparous were enrolled.
February 2007-March 2010 in general OB/GYN clinic at an academic hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Drug (Misoprostol) | 400mcg of buccal misoprostol 90 minutes prior to IUD insertion |
| FG001 | Placebo | Placebo buccal 90 minutes prior to IUD insertion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug (Misoprostol) | 400mcg of buccal misoprostol 90 minutes prior to IUD insertion |
| BG001 | Placebo | Placebo buccal 90 minutes prior to IUD insertion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). | Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right). | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | mm | Time of IUD insertion |
|
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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 | Active Drug (Misoprostol) | 400mcg of buccal misoprostol 90 minutes prior to IUD insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Edelman | Oregon Health & Science University | 503.494.5949 | edelmana@ohsu.edu |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D011453 | Prostaglandins |
| D008277 | Magnesium Oxide |
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Magnesium Oxide | Dietary Supplement | Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes. |
|
|
| At time of IUD insertion |
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo buccal 90 minutes prior to IUD insertion. |
|
|
| Secondary | Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS). | Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right). | ITT | Posted | Mean | Standard Deviation | mm | At time of IUD insertion |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo | Placebo buccal 90 minutes prior to IUD insertion. | 0 | 18 | 0 | 18 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |