Comparison of two different dosing regimens of vaginal misoprostol for cervical priming among women undergoing vaginoscopic hysteroscopy: a noninferiority randomized controlled trial.
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BACKGROUND: Hysteroscopy is considered the gold standard for diagnosing intrauterine pathology. Pain and discomfort experienced during the procedure may be reduced using vaginoscopic methods and cervical priming. Misoprostol is the agent of choice for cervical priming for transcervical procedures. However, the optimal dose, route, and time of administration are debatable. Lower doses may reduce the side effects without reducing the effectiveness of facilitating cervical entry. OBJECTIVE: To compare the efficacy of 100 μg with 200 μg of vaginal misoprostol on ease of cervical entry among women undergoing vaginoscopic hysteroscopy. STUDY DESIGN: This randomized controlled noninferiority trial was conducted, enrolling 120 women who underwent hysteroscopy at a tertiary-level teaching hospital from November 2020 to June 2022. The intervention included 2 dosages of vaginal misoprostol-200 μg (group A) and 100 μg (group B), administered 3 hours before the procedure. No analgesia or anesthesia was used in either group. The primary outcomes measured included assessing the ease of cervical entry on a five-point Likert scale. The secondary outcomes included the following: 1) pain score assessed using a visual analog scale at three time points, 2) time taken for cervical entry and completion of the procedure, and 3) side effects (drug or procedure-related). A test for noninferiority was conducted using a 1-sided Wald test at a significance level of 0.05. RESULTS: Most cases (77.5%) had "easy or very easy" entry through the cervix, which was similar in both groups (group A: 81.7%, [95% confidence interval, 71.9-91.5] vs group B: 73.3%, [95% confidence interval, 62.1-84.5]). The difference between the groups was -8.3%, with 1-sided 95% confidence interval, -20.9% to 100%, P=.063 using the intention-to-treat approach, marginally above the prespecified boundary of 20%, not confirming the noninferiority of the 100-μg to 200-μg dose of misoprostol. The median visual analog scale score at three time points, the mean entry time, and the total procedure duration were comparable between the 2 groups. Adverse effects were commonly noted among those receiving 200 μg compared to 100 μg misoprostol (13 [21.7%] vs 6 [10%], P=.079). CONCLUSION: Regarding cervical priming during vaginoscopic hysteroscopy, using either 100 μg of misoprostol or 200 μg of misoprostol facilitated easy or very easy entry in most cases, though this study was not able to establish noninferiority of the lower dose.
