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| ID | Type | Description | Link |
|---|---|---|---|
| MISO Emory | Other Identifier | Other |
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Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| misoprostol | Experimental | Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit |
|
| placebo | Placebo Comparator | Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale | The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult). | assessed immediately post IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perceived Pain on a 100 Point Visual Analogue Scale | The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain). | immediately after insertion |
| The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Lathrop, MD, MPH | Emory University School of Medicine, Department of Gynecology and Obstetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24034580 | Derived | Lathrop E, Haddad L, McWhorter CP, Goedken P. Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception. 2013 Dec;88(6):725-9. doi: 10.1016/j.contraception.2013.07.011. Epub 2013 Aug 6. | |
| 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. |
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Seventy-eight nulliparous women were enrolled, and 71 completed the study. Five dropped out prior to randomization and method insertion choosing other birth control options.
Enrollment occurred at a faculty practice clinic affiliated with Emory University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol | Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit |
| FG001 | Placebo | Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol | Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit |
| BG001 | Placebo | Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit |
| 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 | Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale | The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult). | Posted | Median | Full Range | units on a scale | assessed immediately post 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 | Misoprostol | Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Lathrop, MD, MPH | Emory University | 404-778-1379 | elathro@emory.edu |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Placebo |
| Drug |
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit |
|
| assessed immediately after IUD insertion |
| Time for Insertion Procedure | assessed immediately after IUD insertion |
| Acceptability of Discomfort Associated With Insertion | assessed at one week after insertion and at one month after insertion |
| Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women | assessed immediately following insertion |
| Need for Additional Pain Medications After Insertion of the IUD | assessed one week after insertion |
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Patient Perceived Pain on a 100 Point Visual Analogue Scale | The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain). | Posted | Median | Full Range | units on a scale | immediately after insertion |
|
|
|
| Secondary | The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD | Posted | Number | participants | assessed immediately after IUD insertion |
|
|
|
| Secondary | Time for Insertion Procedure | Data were not collected for this outcome measure. The provider questionnaire developed for this study was piloted prior to study initiation and this question was removed for clarity and to focus on the primary study aims. | Posted | assessed immediately after IUD insertion |
|
|
| Secondary | Acceptability of Discomfort Associated With Insertion | Data were not collected for this outcome measure. The follow-up participant questionnaires developed for this study were piloted prior to study initiation and this question was removed for clarity, to focus on the primary study aims, and to reduce participant burden. | Posted | assessed at one week after insertion and at one month after insertion |
|
|
| Secondary | Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women | Data were not collected for this outcome measure. The participant questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about prior pregnancies) were removed for clarity, to focus on the primary study aims, and to reduce participant burden. | Posted | assessed immediately following insertion |
|
|
| Secondary | Need for Additional Pain Medications After Insertion of the IUD | Data were not collected for this outcome measure. The follow-up questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about medication use) were removed for clarity, to focus on the primary study aims, and to reduce participant burden. | Posted | assessed one week after insertion |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Placebo | Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit | 0 | 36 | 0 | 36 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |