Cervical Priming by Vaginal or Oral Misoprostol Before Operative Hysteroscopy: A Double-Blind, Randomized Controlled Trial.

STUDY OBJECTIVE

To evaluate whether misoprostol oral is as effective as vaginal tablets for cervical ripening.

DESIGN

Randomized controlled trial involving a parallel, double-blinded study (Canadian Task Force Classification IB).

SETTING

Department of Obstetrics and Gynecology, Cairo University Hospital, between January 2014 and January 2016.

PATIENTS

Patients undergoing operative hysteroscopy for various indications.

INTERVENTIONS

At 12 hours before hysteroscopy, the oral group received a 400-μg misoprostol tablet and 2 vaginal starch tablets. The vaginal group received 400 μg of misoprostol and 2 oral starch tablets. The control group received 2 oral starch and 2 vaginal starch tablets as placebo. Preoperative preparation was the same in all patients.

MEASUREMENTS AND MAIN RESULTS

The main outcome measures were width of the endocervical canal, ease of dilatation, time to dilatation, and adverse effects. All subjects eligible for operative hysteroscopy (n = 430) were invited to participate. Twenty subjects refused, and 20 subjects were excluded. The enrolled subjects (n = 390) were randomized to oral misoprostol, vaginal misoprostol, or placebo. The differences in mean width of the endocervical canal between the oral and the control groups (4.79 ± 1.07 mm vs 3.92 ± 0.92 mm), and also between the vaginal and the control groups (4.25 ± 0.71 mm vs 3.92 ± 0.92 mm) were significant (p < .001 for both). Moreover, the difference in mean width of the endocervical canal between the oral and the vaginal groups was significant (4.79 ± 1.07 mm vs 4.25 ± 0.71 mm; p = .009). Cervical entry was easier in the oral and vaginal groups compared with the control group (mean Likert score, 4.25 ± 0.64 vs 4.22 ± 0.74 vs 2.55 ± 0.87; p < .001). In addition, the ease of cervical entry did not differ significantly between the oral and vaginal groups (p = .998). The mean time to dilatation was shorter in the oral group and the vaginal group (compared with the control group (48.98 ± 12.6 seconds vs 46.55 ± 15.32 seconds vs 178.05 ± 74.18 seconds; p < .001), but the difference between the oral and vaginal groups was not significant (p = .987). Adverse effects were comparable between groups (p > .05).

CONCLUSION

We found no statistically significant difference in the efficacy of cervical priming between oral misoprostol and vaginal misoprostol.