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This trial was a randomized double-blind control trial of 89 women undergoing consecutive removal and replacement of a levonorgestrel-releasing intrauterine device (LNG-IUD). Of note, this study was part of a larger multicenter trial evaluating the bleeding profile and safety with repeat use of a LNG-IUD in women who had used their first device for close to 5 years.

Misoprostol Is Not for Everyone

December 1, 2010

Misoprostol Is Not for Everyone

Abstract & Commentary

By Alison Edelman, MD, MPH, Associate Professor, Assistant Director of the Family Planning Fellowship, Department of Obstetrics & Gynecology, Oregon Health & Sciences University, Portland, is Associate Editor for OB/GYN Clinical Alert.

Dr. Edelman reports no financial relationship to this field of study.

Synopsis: The routine use of misoprostol for intrauterine device insertion did not "ease" insertion for patients or providers.

Source: Heikinheimo O, et al. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception 2010;81:481-486.

This trial was a randomized double-blind control trial of 89 women undergoing consecutive removal and replacement of a levonorgestrel-releasing intrauterine device (LNG-IUD). Of note, this study was part of a larger multicenter trial evaluating the bleeding profile and safety with repeat use of a LNG-IUD in women who had used their first device for close to 5 years. Women were randomized to 400 mg of sublingual misoprostol or placebo 3 hours prior to their procedure. The main goal of the study was to assess the ease of insertion for providers and then also side effects and adverse events. The majority of the women enrolled were parous, with nulliparous rates of only 9% and 2% in the misoprostol and placebo groups, respectively. Ease of removal and insertion for providers was no different between the groups with more than 90% reporting both were easy. "Ease" or pain of removal and insertion reported by the women undergoing these procedures was worse in the misoprostol group (severe pain reported with removal 14% vs 2% and insertion 23% vs 11%). Rates of adverse events were also significantly higher in the misoprostol group, 51% vs 11%.

Commentary

Misoprostol or PGE1 is the wonder drug of the 21st century for many of us in obstetrics and gynecology and it seems we use it for everything these days including labor induction, miscarriage management, cervical priming for hysteroscopy, and abortion care. In fact, I am surprised that we have not trialed it as a sweetener for our morning coffee (don't try this, it does not taste very good). However, this and several other published trials studying the routine use of misoprostol for intrauterine device insertions1,2 are a good reminder that in our effort to do better, we often do harm. Remember bloodletting that didn't work out so well for the field of medicine either.

This study originated in the homeland of the levonorgestrel-releasing intrauterine device (LNG-IUD), Finland. In Finland's vast experience with this device, there are anecdotal reports of second insertions being more difficult, thought perhaps to be due to the atrophic effect of progestin on the uterus and cervix. Interestingly, across the pond in the United States, there appears to be worries regarding a different population with difficult insertions, the nulliparous woman. There is increasing anecdotal reports of routine misoprostol use prior to IUD insertion in these patients, in hopes of making the insertion easier. However, the evidence is consistent and growing that the use of misoprostol routinely for both multiparous or nulliparous does not ease placement for the provider or the patient.1,2 What has been found is that the majority of IUD placements are easy in both multiparous and nulliparous women and that routine use of misoprostol increases the discomfort a woman experiences prior to and during her IUD removal and insertion.1,2 In other words, more harm than good. Studies have not followed women after their IUD placement to document if they experience more discomfort once they leave the clinic and no study has been powered to determine if there is a difference in expulsion rate. Finally, what about using misoprostol only in patients who have had a failed first attempt? A very small case series (8 women) demonstrated that it might be helpful, but stay tuned, as more work in this area is needed.3

So how can we make IUD insertion easier? Since the majority of providers (more than 90%) reported that IUD insertion was easy with or without misoprostol we are hard pressed to find an agent to increase our ease. For patients, making insertion easier is best done by avoiding routine use of misoprostol prior to IUD insertion.

References

  1. Saav I, et al. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: A randomized controlled trial. Hum Reprod 2007;22:2647-2652.
  2. Scavuzzi M, et al. Misoprostol prior to insertion of intrauterine device in nullipara. Int J Gynaecol Obstet 2009;107(Suppl 2):S393-S396.
  3. Li YT, et al. Cervical softening with vaginal misoprostol before intrauterine device insertion. Int J Gynaecol Obstet 2005;89:67-68.