A Phase 3 interventional study of Misoprostol in Cervical Ripening, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-12-02.
Sponsored by Samsung Medical Center · Phase 3 and Interventional
The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. The secondary outcomes were duration of cervical dilatation, up to Hegar number 10, complications during cervical dilation and the hysteroscopy, and misoprostol associated side effects. The cervical width was assessed by performing cervical dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilatators until the dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.
The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that equivalence was of clinical significance if the difference in the initial cervical width was less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6 mm. The estimated sample size was 47 patients in each group; this would be able to detect an equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of cases.
Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Drug: Misoprostol
The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.
Time frame: 1 year
Duration of cervical dilatation, up to Hegar number 10.
Time frame: 1 year
Complications during cervical dilation.
Time frame: 1 year
Misoprostol associated side effects.
Time frame: 1 year
Complications during the hysteroscopy.
Time frame: 1
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center