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Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol sublingual,1h | Active Comparator | Administration of misoprostol sublingually 1h prior to surgery |
|
| Misoprostol sublingual. 3h | Active Comparator | Administration of misoprostol sublingually 3h prior to surgery |
|
| Misoprostol vaginal,1h | Active Comparator | Administration of misoprostol vaginally 1h prior to surgery |
|
| Misoprostol vaginal,3h | Active Comparator | Administration of misoprostol vaginally 3h prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol sublingual, 1h | Drug | Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Force needed for cervical dilatation | Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer. Force and time needed for the dilatation is recorded by the tonometer | Measured at surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical diameter | Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer.The largest dilator that can pass through the inner cervical os without any resistance corresponds to the presurgical cervical diameter | Measured at surgery |
| Number of Participants with Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Gemzell Danielsson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25840429 | Derived | Saav I, Kopp Kallner H, Fiala C, Gemzell-Danielsson K. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT. Hum Reprod. 2015 Jun;30(6):1314-22. doi: 10.1093/humrep/dev071. Epub 2015 Apr 2. |
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| Placebo sublingual,1h | Drug | Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy |
|
| Misoprostol sublingual, 3h | Drug | Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy |
|
| Misoprostol vaginal, 1h | Drug | Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy |
|
| Misoprostol vaginal, 3h | Drug | Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy |
|
| Placebo sublingual, 3h | Drug | Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy |
|
| Placebo vaginal, 1h | Drug | Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy |
|
| Placebo vaginal, 3h | Drug | Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy |
|
Any side effects or symptoms such as nausea, vomiting, uterine cramps, expulsion, bleeding, rash, chills, blood pressure etc are recorded continuously from misoprostol administration until to surgery |
| Up to surgery |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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