Cervical Ripening in Postmenopausal Women

Not Applicable

Terminated

Conditions: Stenosis of Cervix

Interventions: Drug: Misoprostol
Drug: Placebo

Registration Number: NCT02534883

Lead Sponsor: St. Louis University

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 11

Inclusion Criteria

45-80yrs of age
Postmenopausal (amenorrhea for greater than 1 year)
May or may not be using hormone replacement therapy
Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures

Exclusion Criteria

Pregnant
Known Cancer
Known hypersensitivity to prostaglandins.
Those who are breastfeeding

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Misoprostol	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	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.

Primary Outcome Measures

Name	Time	Method
Efficacy (Cervical Ripening)	At time of surgery/cervical dilation	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Dilator Size	At time of procedure.	The largest cervical dilator that could be passed through the internal cervical os.
Number of Recorded Side Effects.	At time of surgery/cervical dilation	Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects
Dilation Time in Minutes	At time of procedure.	Time from beginning of cervical dilation to completion of cervical dilation.
Number of Complications	At time of procedure.	Count of complications at time of surgery.
Resistance Score	At time of procedure.	Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being "normal."