A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
the preoperative cervical width
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.
just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)
No
Taejong Song, MD
Principal Investigator
Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
Korea: Food and Drug Administration
KNC13-005
NCT01805115
March 2013
July 2014
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