Heavy periods less likely to lead to hysterectomy with endometrial ablation plus IUD combo

In the treatment of women with heavy menstrual bleeding, the insertion of a levonorgestrel-releasing intrauterine device (LNG-IUS) immediately after endometrial ablation substantially reduces the risk of hysterectomy, according to the MIRA2 trial.

MIRA2 was an open-label, randomized controlled superiority trial conducted across 34 hospitals in the Netherlands. A total of 715 women below 60 years of age (median age 45 years) who had heavy menstrual bleeding and were eligible for endometrial ablation participated in the trial.

The participants were randomly assigned to undergo combined treatment comprising endometrial ablation plus LNG-IUS (n=359) or to standard care comprising endometrial ablation alone (n=356). Endometrial ablation was performed using electrical radiofrequency ablation or by transcervical resection of the endometrium. An LNG-IUS containing 52 mg of levonorgestrel was inserted immediately after the ablative procedure for participants in the combined treatment group.

Over 2 years of follow-up, hysterectomy was performed in 4 percent of participants in the combined treatment group vs 10 percent of those in the endometrial ablation group (p=0.0040), corresponding to a relative risk reduction of 0.43 (95 percent confidence interval [CI], 0.24–0.77; p=0.0050) with combined treatment.

Serious adverse events occurred in 8 percent of participants each in the combined treatment group and endometrial ablation alone group (relative risk, 0.98, 95 percent CI, 0.59–1.65; p=0.94). There were no treatment-related deaths reported.

The findings indicate that combined treatment represents an adjunctive strategy for heavy menstrual bleeding that does not increase the risk of complications.