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The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. 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 use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. |
|
| Placebo | Placebo Comparator | Pills which are identical to the study drug in appearance, taste, and smell. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) | VAS (anchors: 0 = extremely easy, 100 mm= impossible) | Immediately post IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | VAS; anchors: 0 =none, 100 mm= worst imaginable | prior to insertion, immediately after insertion, and prior to clinic discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Turok, MD/MPH | University of Utah Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Association of Utah | Salt Lake City | Utah | 84111 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22825094 | Derived | Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9. | |
| 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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Participants had an initial study visit where the consent was signed and they were given misoprostol or placebo to take at home. Participants and providers were blinded to the treatment group.
Patients were recruited from July 2009 to November 2010. All IUD insertions occurred at the University of Utah Ob/Gyn clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol | Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. |
| FG001 | Placebo | Pills which are identical to the study drug in appearance, taste, and smell. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol | Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. |
| BG001 | Placebo | Pills which are identical to the study drug in appearance, taste, and smell. |
| 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 (VAS) | VAS (anchors: 0 = extremely easy, 100 mm= impossible) | 2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion. | Posted | Mean | Standard Deviation | units on a scale | Immediately post IUD insertion |
|
|
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2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for 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 400 micrograms inserted vaginally or buccally, per the participants desire. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Turok | University of Utah, Department of Obstetrics and Gynecology | 801-581-7647 | david.turok@hsc.utah.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 | Pills which are identical to the study drug in appearance, taste, and smell. |
|
| Salt Lake City |
| Utah |
| 84132 |
| 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 |
|
| Participants |
|
|
|
| Secondary | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | VAS; anchors: 0 =none, 100 mm= worst imaginable | 2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion. | Posted | Mean | Standard Deviation | units on a scale | prior to insertion, immediately after insertion, and prior to clinic discharge |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Placebo | Pills which are identical to the study drug in appearance, taste, and smell. | 0 | 51 | 0 | 51 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| prior to clinic discharge |
|