Comparative study of the effectiveness of two different dosage of sublingual misoprostal for cervical ripening before hysteroscopy

Abstract

Background: Hysteroscopy a minimally invasive approach for evaluating uterine cavity, and has become an indispensable diagnostic and therapeutic procedure. The main limiting factor while performing office hysteroscopy is the level of pain or discomfort encountered during the procedure. The pain is attributed mainly to the difficulty in entering the internal cervical os with the hysteroscope and while distending uterine cavity. It could be reduced if cervix is ripened before the procedure. The purpose of this prospective observational study was to compare the effectiveness, adverse effects and surgery-related complications associated with two different doses of sublingual Misoprostol (100 and 200 µg) given 2-4 hours before hysteroscopy.Methods: A randomised comparative study was conducted in the department of Obstetrics and Gynaecology of ABVIMS and Dr. RML hospital New Delhi, from 1st November, 2018 to 31st March, 2020. One hundred and twenty women, fulfilling inclusion criteria were subjected to hysteroscopy. Women received either 100 µg (Group I) or 200 µg (Group II) of sublingual Misoprostol 2-4 hours prior to hysteroscopy. The primary outcome of the study was cervical dilatation as measured by the largest number of Hegar dilator that could be inserted without resistance at the beginning of procedure. The largest dilator that negotiated cervical canal without resistance at the beginning of procedure was recorded as the baseline cervical width. The secondary outcomes were subjective assessment of the surgeon of the ease of dilatation of cervix and adverse effects of drug (i.e. vaginal bleeding, shivering, fever and pain as measured on visual analog scale).Results: The mean baseline cervical width as measured by first Hegar dilator that could be passed through the cervical canal without resistance was 6.6±0.62 mm in group I and 6.94±1.21 mm in group II respectively (p value=0.016). Adverse effects like vaginal bleeding, shivering was more in group II compared to group I. No statistically significant difference was found between group I and II with regards to visual analog scale.Conclusions: 100 µg Misoprostol can be used for cervical ripening prior to hysteroscopy with minimal adverse effects.

Comparison between 200 μg and 800 μg of vaginal misoprostol for cervical ripening before operative hysteroscopy: A randomized controlled trial

“…21,22 An Indian clinical trial involving 120 participants compared 100-and 200μg doses of misoprostol administered sublingually to premenopausal women 2-4 h before hysteroscopy and concluded that the 100μg dose can be used for cervical ripening before hysteroscopy with minimal adverse events. 23 Our findings are corroborated by a Chinese meta-analysis that evaluated cervical width before diagnostic and operative hysteroscopy, comparing high and low doses of misoprostol with placebo or no medication. That meta-analysis concluded that 200-or 400μg doses of vaginal misoprostol were more beneficial than higher doses (800 and 1000 μg).…”

“…A clinical trial comparing 200‐ and 400‐μg doses administered vaginally to 68 participants 8 h before hysteroscopy reported no complications 21 and a study that compared 200‐ and 400‐μg doses administered orally 1 h before operative hysteroscopy found no difference between the groups in relation to complication rates except for two cases of perforation in the 200‐μg dose group 22 . A study that analyzed 100‐ and 200‐μg doses administered sublingually 2–4 h before surgery in 120 participants reported no statistically significant difference between the two groups insofar as cervical perforation, the creation of false passage and having to abandon the procedure were concerned 23 . In the present study, complications were few in both groups, with no statistically significant differences.…”

“…The Indian clinical trial comparing 100μg and 200μg doses concluded that cervical entry classified as "very easy" was more common in the 200μg group (38.33% vs 5%; P < 0.001), while entry classified as "easy" was more common in the 100μg group (61.67% vs 31.67%; P = 0.002). 23 The French clinical trial evaluating 200-, 400-, and 800μg doses of misoprostol and placebo reported no difference in mean time until dilatation between the 200-and 800μg doses (35 ± 27 s, P = 0.29 F I G U R E 1 Flow diagram of patients submitted to cervical dilatation using misoprostol at a dose of 200 or 800 μg for cervical ripening before operative hysteroscopy and 30 ± 31 s, P = 0.094). 20 Conversely, in the present study, mean time until dilatation was 13 s shorter in the 800μg group and this difference was statistically significant.…”

“…Clinical trials evaluating 200‐ and 400‐μg doses administered vaginally either 8 or 1 h before the procedure recommended the 200‐μg dose as it caused fewer adverse events with similar intraoperative results 21,22 . An Indian clinical trial involving 120 participants compared 100‐ and 200‐μg doses of misoprostol administered sublingually to premenopausal women 2–4 h before hysteroscopy and concluded that the 100‐μg dose can be used for cervical ripening before hysteroscopy with minimal adverse events 23 …”

“…No differences were found between the groups regarding ease of dilatation. The Indian clinical trial comparing 100‐μg and 200‐μg doses concluded that cervical entry classified as “very easy” was more common in the 200‐μg group (38.33% vs 5%; P < 0.001), while entry classified as “easy” was more common in the 100‐μg group (61.67% vs 31.67%; P = 0.002) 23 …”