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This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol
Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Misoprostol | Active Comparator | 400 µg of dry misoprostol |
|
| Wet misoprostol | Experimental | 400 µg of wet misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dry misoprostol | Drug | 400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical dilation | Cervical dilation will be measure with Karman cannulas | 3 to 4 hours after putting misoprostol into the vagina |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal acidity - hydrogen ion concentration | at the moment of the introduction of misoprostol into the vagina | within 2 min before putting the misoprostol into the vagina |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo F Savaris, MD, PhD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO. The Prevention and management of unsafe abortion: report of a technical working group, Geneva, 12-15 April 1992. 1993 | ||
| 11023804 | Background | Regan L, Rai R. Epidemiology and the medical causes of miscarriage. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Oct;14(5):839-54. doi: 10.1053/beog.2000.0123. | |
| 17126724 |
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| wet misoprostol | Drug | 400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation |
|
| Background |
| Grimes DA, Benson J, Singh S, Romero M, Ganatra B, Okonofua FE, Shah IH. Unsafe abortion: the preventable pandemic. Lancet. 2006 Nov 25;368(9550):1908-19. doi: 10.1016/S0140-6736(06)69481-6. |
| 16581405 | Background | Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9. |
| 23543549 | Background | Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007223. doi: 10.1002/14651858.CD007223.pub3. |
| 9609268 | Background | Fong YF, Singh K, Prasad RN. A comparative study using two dose regimens (200 microg or 400 microg) of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. Br J Obstet Gynaecol. 1998 Apr;105(4):413-7. doi: 10.1111/j.1471-0528.1998.tb10126.x. |