Effectiveness of misoprostol in office hysteroscopy in premenopausal nulliparous women: A prospective randomized double-blind placebo-controlled trial

Abstract

Study Objective: The objective of this was to evaluate the effectiveness of misoprostol in premenopausal nulliparous women with 200-mcg single vaginal dose 4 h before the procedure. Design: This was a prospective randomized double-blind placebo-controlled trial. Setting: This study was conducted in a tertiary care and academic research center. Patients: One hundred patients were included in the study: 50 in misoprostol group and 50 in placebo. Interventions: Patients underwent office hysteroscopy 4 h after vaginal application of misoprostol or placebo. Measurements and Main Results: Ease of doing hysteroscopy was significantly better in the misoprostol group (difficulty score: 2.74 ± 1.20) as compared to placebo (difficulty score: 4.20 ± 1.10), P = 0.001. The time taken for negotiating the internal os (cervical passage time) was found to be significantly shorter in the misoprostol group (6.20 ± 5.21 s) as compared to placebo (14.78 ± 11.84 s), P = 0.001. The overall Visual Analog Scale (VAS) score was significantly lower in the intervention group (2.64 ± 1.62) as compared to placebo (4.90 ± 1.90), P = 0.001. Moreover, the VAS score at the point of passing internal os was significantly lower in the misoprostol group (2.82 ± 1.39) as compared to placebo (4.94 ± 1.96), P = 0.001. Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n = 9) in placebo, P = 0.001. Furthermore, 78% ( n = 39) of women in the misoprostol group would recommend the procedure to their friends and relatives versus 36% ( n = 18) in placebo, P = 0.001. Conclusion: Preoperative cervical preparation with 200 mcg of misoprostol vaginal application 4 h before office hysteroscopy in premenopausal nulliparous women significantly reduces the difficulty encountered in negotiating the cervical canal. Further, it significantly reduces the pain experienced by the patient at the point of passage through internal os as well as throughout the entire procedure.

Cervical dilatation and preparation prior to outpatient hysteroscopy: a systematic review and meta‐analysis

“…Likewise, four studies could not find a statistical difference in satisfaction between women randomised to a cervical preparation or placebo/nil ( P > 0.05) 20,27,28,36 . A significantly higher proportion of premenopausal nulliparous women, when randomised to misoprostol compared with placebo, would undergo the procedure again if required ( P ≤ 0.02), 35,42 would not prefer additional anaesthesia ( P < 0.01) 35 and would recommend hysteroscopy to a friend/relative ( P ≤ 0.02) 35,42 …”

“…Figure S1 summarises the study selection process. The literature search yielded 807 records and 24 studies were suitable for systematic review, [18][19][20][21][22][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] of which one trial was added after screening the reference lists of included studies. 41 Nineteen studies provided data for meta-analysis.…”

“…39 No study examined whether routine mechanical dilatation of the cervix before outpatient hysteroscopy reduced pain associated with hysteroscopy. Twenty-one studies compared the use of a cervical preparation (misoprostol, mifepristone, carboprost, dinoprostone) against a control (placebo, nil, phloroglucinol, bladder distension, dinoprostone, buscopan), [18][19][20][21][22][24][25][26][27][28][29]31,32,[34][35][36][38][39][40][41][42] three studies compared two different doses of the same cervical preparation (200 versus 400 lg misoprostol) 18,30,37 and one study compared two different timings of administration of the same cervical preparation (3 hours versus 12 hours pre-procedurally). 33…”

“…Impact on pain Meta-analysis of 11 studies, 18,19,24,28,[34][35][36][38][39][40]42 including 2653 women, showed that cervical preparation led to a statistically significant reduction in pain during outpatient hysteroscopy compared with placebo (SMD -0.67, 95% CI -1.05 to -0.29). Subgroup analysis according to study quality reduced, but failed to eliminate, the degree of inconsistency, lowering the I 2 value from 93 to 79% (Figure 1).…”

“…Subgroup analysis according to study quality reduced, but failed to eliminate, the degree of inconsistency, lowering the I 2 value from 93 to 79% (Figure 1). Subgroup analysis according to the agent given showed that both misoprostol (eight studies, 18,19,28,34,35,38,39,42 881 women) and dinoprostone (one study, 40 100 women) significantly reduced mean pain scores during hysteroscopy with SMDs (95% CI) of -0.64 (-0.97 to -0.31) and -2.24 (-2.75 to -1.74), respectively (Figure 2). Although evidence was limited to one study each, mifepristone 24 (58 women) and carboprost 36 (1314 women) did not show a significant difference in intra-procedural pain when administered before hysteroscopy with SMDs (95% CI) of -0.13 (-0.65 to 0.38) and 0.09 (-0.02 to 0.20), respectively.…”