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Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for all operative hysteroscopic procedures requiring dilation above 5 mm.
Time required for cervical dilatation will be recorded. Start time will be when the smallest dilator is placed into the endocervical canal, and stop time recorded when the desired cervical dilation is achieved with the largest dilator. Depending on the procedure, desired dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of dilatation.
The investigators will compare the two groups in terms of medication, resistance, dilation time and size, side effects and surgical complications.
This study will be a randomized, double blinded, placebo controlled trial.
Patients will be assigned by chance to receive 200ug of misoprostol or placebo (empty gelatin capsule) vaginally twice (for a total of 400ug). There is no standard of care, but to receive misoprostol or not are both accepted practices and that Standard of Care is for the clinicians to use clinical judgment .
Patients will be randomized to one of the following treatment regimens:
Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). St. Mary's pharmacy will prepare capsules with each containing 200ug of misoprostol.
Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.
The two groups, will be compared in terms of side effects, resistance, dilation time, size and surgical complication.
Randomization will occur using a computer program called Research Randomizer, http://www.randomizer.org/form.htm. A set of 100 non-unique numbers will be randomized. Once the randomization list is generated, envelopes will be made. Based on the randomizer results a folder slip of paper with the treatment (misoprostol or placebo) written on it will be placed in sequential numbered envelopes. The number on the envelope will be the patients code number. An unblinded member of the research team will open the randomized envelope, and log into a master drug log the randomization.
The medication and/or placebo will be place in numbered sequentially bottles with a master drug log containing which is misoprostol and which is placebo. Each bottle will have child proof lids for dispensing and will be labeled misoprostol 200ug/each/placebo), physician name (Ward) and contact number, and "For investigational use only" will also be noted.
The unblinded staff will notify the research member consenting the patient and inform them of what number bottle to give to the patient, in the office before surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). |
|
| Group 2 | Placebo Comparator | Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | To be place vaginally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Cervical Ripening) | To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation. | At time of surgery/cervical dilation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Recorded Side Effects. | Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects | At time of surgery/cervical dilation |
| Dilation Time in Minutes | Time from beginning of cervical dilation to completion of cervical dilation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Ward, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Health Center | St Louis | Missouri | 63117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol Group | Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol). Misoprostol: To be placed vaginally |
| FG001 | Placebo Group | Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery. Placebo: To be placed vaginally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data not compiled because of early termination
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol Group | Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol). Misoprostol: To be placed vaginally Baseline characteristics not compiled because of early termination. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 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 | Efficacy (Cervical Ripening) | To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation. | Outcome measures presented below. | Posted | Mean | Standard Deviation | minutes | At time of surgery/cervical dilation |
|
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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 Group | Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol). Misoprostol: To be placed vaginally |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald Gregory Ward, MD | St. Louis University | 314-781-1505 | 1 | dgreg.ward@health.slu.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 | To be placed vaginally |
|
|
| At time of procedure. |
| Maximum Dilator Size | The largest cervical dilator that could be passed through the internal cervical os. | At time of procedure. |
| Number of Complications | Count of complications at time of surgery. | At time of procedure. |
| Resistance Score | Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being "normal." | At time of procedure. |
| Placebo Group |
Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery. Placebo: To be placed vaginally Baseline characteristics not compiled because of early termination. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 11 enrolled. One participant withdrew because her surgery was cancelled and not rescheduled. Data sheet completed at time of surgery and thus only available for 10 participants. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Placebo: To be placed vaginally |
|
|
| Secondary | Number of Recorded Side Effects. | Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects | Posted | Mean | Standard Deviation | number of side effects out of seven | At time of surgery/cervical dilation | side effects | side effects |
|
|
|
| Secondary | Dilation Time in Minutes | Time from beginning of cervical dilation to completion of cervical dilation. | Posted | Mean | Standard Deviation | minutes | At time of procedure. |
|
|
|
| Secondary | Maximum Dilator Size | The largest cervical dilator that could be passed through the internal cervical os. | Posted | Mean | Standard Deviation | millimeters | At time of procedure. |
|
|
|
| Secondary | Number of Complications | Count of complications at time of surgery. | Posted | Mean | Standard Deviation | complications | At time of procedure. |
|
|
|
| Secondary | Resistance Score | Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being "normal." | Posted | Mean | Standard Deviation | units on a scale | At time of procedure. |
|
|
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo Group | Group 1 will receive placebo (empty gelatin capsule) to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery. Placebo: To be placed vaginally | 0 | 3 | 0 | 3 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |