Comparison of Efficacy of Vaginal Misoprostol 100 Micrograms Versus 200 Micrograms for Cervical Priming Prior to Operative Hysteroscopy: A Randomized Controlled Trial

AIMS: To assess and determine the minimum possible dose of vaginal misoprostol that produces optimal cervical dilation prior to operative hysteroscopy thereby resulting in less drug related side effects and increase patient related safety and acceptability of the procedure. OBJECTIVES: Primary Objective: 1. To compare the baseline cervical width at the beginning of procedure assessed by the largest number Hegar dilator that could be inserted into cervix without resistance. 2. To assess ease of entry of hysteroscope into the cervix recorded on a five point Likert scale. Secondary Objectives: 1. The need for further cervical dilatation in both groups. 2. Adverse effect of misoprostol administration 3. Complications of operative hysteroscopy. METHODS: We performed a double blinded randomised control trial among all reproductive age women planned for operative hysteroscopy in view of various intrauterine pathologies were explained about the study and given an information sheet. Inclusion and exclusion criteria were applied and patients were recruited after obtaining a written consent form. Eligible participants were randomised to undergo an operative hysteroscopy with either 100 mcgs or 200 mcgs administered vaginally as pre-treatment prior to the procedure. The primary objective was to compare the baseline cervical width in both the low and high dose groups at the beginning of procedure assessed by the largest number Hegar dilator that could be inserted into cervix without resistance. The primary outcome was to determine the baseline cervical width at the beginning of the procedure assessed by the largest number of Hegar dilator that could be inserted into the cervix without resistance. The secondary outcomes were the ease of entry of the hysteroscope into the cervix recorded on a 5-point Likert scale and adverse effects of misoprostol administration. Allocation using SAS 9.4. Randomization was done according to computer generated block randomization. Pre numbered or coded identical containers for the Group A and Group B were prepared which were administered serially to patients. The study was double blinded.16 patients were randomized, 8 to group A (Low dose -100 mcgs) and 8 to Group B (High dose-200 mcgs) .Recruitment is still ongoing. RESULTS: Baseline characteristics were similar between both groups. The baseline cervical width at the beginning of procedure assessed by the largest number Hegar dilator that could be inserted into cervix without resistance, compared between both groups was not found to be significant (p = 0.76). The ease of entry of hysteroscope into the cervix recorded on a five point Likert scale was comparable in both groups (p = 0.38). Other secondary outcomes were similar among both groups. CONCLUSION: Both 100 and 200 mcg misoprostol vaginally administered are equally effective for cervical dilatation before hysteroscopy. Increasing the dose of misoprostol did not improve the property and effect on cervical dilatation, suggesting that both the regimens were equally efficacious