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This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PO Misoprostol | Active Comparator | Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy |
|
| PV Misoprostol | Active Comparator | Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy |
|
| Buccal Misoprostol | Active Comparator | Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol (Cytotec) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative cervical width in centimeters | Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time required to achieve cervical dilatation | The time in minutes required for dilatation up to a number 10 Hegar | intraoperative |
| Ease of cervical dilatation | The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Ganer Herman, MD | Contact | 972526206696 | hadassganer@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Wolfson Medical Center | Recruiting | Holon | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28069480 | Derived | Ganer Herman H, Kerner R, Gluck O, Feit H, Keidar R, Bar J, Sagiv R. Different Routes of Misoprostol for Same-Day Cervical Priming Prior to Operative Hysteroscopy: A Randomized Blinded Trial. J Minim Invasive Gynecol. 2017 Mar-Apr;24(3):455-460. doi: 10.1016/j.jmig.2016.12.024. Epub 2017 Jan 7. |
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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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| intraoperative |
| Patient preference | Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable) | baseline |
| Adverse effects of medication | Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting) | baseline |
| Surgical complications | Complications arising during surgery (perforation, cervical laceration, excess bleeding) | intraoperative |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |