Stenosis of Cervix Clinical Trial
Official title:
Cervical Ripening in Postmenopausal Women: A Randomized, Double Blind, Placebo Controlled Trial
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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