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The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.
IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| misoprostol | Experimental | 400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion |
|
| Placebo | Placebo Comparator | Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale | after IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia | during IUD insertion | |
| Side effects of medications | prior to IUD insertion | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPH-Kino multispecialty clinic | Tucson | Arizona | 85713 | United States | ||
| University Medical Center Ob/Gyn clinic 8OPC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24215850 | Derived | Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial. Am J Obstet Gynecol. 2014 Mar;210(3):208.e1-5. doi: 10.1016/j.ajog.2013.11.018. Epub 2013 Nov 8. | |
| 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 17, 2013 | |
| Reset | Aug 21, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2013 | Aug 21, 2013 |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Placebo | Drug | 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion |
|
| Provider perceived ease of insertion on a 100 mm visual analogue scale |
| after IUD insertion |
| Acceptability of wait time prior to IUD placement | 1 week after IUD insertion |
| Procedure complications | Up to 1 month after IUD placement |
| Acceptability of total IUD placement process, would you recommend this to a friend? | 1 week and 1 month after IUD insertion |
| Tucson |
| Arizona |
| 85724 |
| United States |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |