CHA Gangnam Medical Center
Seoul, 135-081, South Korea
NCT Number: NCT01805115
The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.
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Notify Me18 year–55 year
Female
Interventional
Phase 3
Seoul, 135-081, South Korea
The route of administration of misoprostol for cervical dilatation prior to operative hysteroscopy can be oral, vaginal, or sublingual. However, it is still unclear which route is more effective and less harmful for cervical dilation prior to operative hysteroscopy in premenopausal women. Furthermore, there have been no studies comparing among oral, sublingual, and vaginal misoprostol, no medication (control) in these women. The objective of this study is to compare the efficacy and safety of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Symptomatic patients that were suspected as having intrauterine pathology, such as submucosal myoma, endometrial polyp or other endometrial pathological findings based on the transvaginal ultrasound, were enrolled.
Inclusion criteria
were as follows: women who were of reproductive age (i.e., were premenopausal) and were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). -
Exclusion criteria
Exclusion criteria
included any evidence of a contraindication to prostaglandins (history of severe asthma, glaucoma, preexisting severe cardiac disease, or renal failure), or allergy to prostaglandins, any sign of genital infection, presence of significant uterovaginal prolapse that could affect administration of vaginal tablets, history of cervical surgery, presence of space occupying lesions in endocervical canal, and treatment of GnRH agonist.
Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
Other names: two tablets of Cytotec (200 μg)
Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
Other names: two tablets of Cytotec (200 μg)
Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
Other names: two tablets of Cytotec (200 μg)
The control group was not given any cervical priming agents or placebo.
Time frame: just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)
The primary outcome measure was the preoperative cervical width at the time of operation. The cervical width was assessed by performing cervical dilation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.
Time frame: before the procedures
CHA University
Other
A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy
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