Research examines interventions for reducing pain during IUD insertion

More studies needed to identify ideal solution for pain reduction

More women are taking a second look at the intrauterine device (IUD) for contraception. IUD insertions went up 23% between January 2008 and January 2009, according to SDI Health, a health care analytics firm in Plymouth Meeting, PA.1 While better access to information and a decreasing stigma against the device has led more women to consider the IUD, many women might choose another method due to fear of pain during insertion.

While most women experience mild-to-moderate discomfort during IUD insertion, rarely is the pain is severe. A 2006 study identified nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding as predictors of pain during IUD insertion.2

Researchers have looked at different ways to reduce pain during IUD insertion. These options include drugs that reduce cramping of the uterus, such as nonsteroidal anti-inflammatory drugs (NSAIDs), drugs that soften and open the cervix, and drugs that numb the cervix. A 2009 Cochrane Review examined all randomized controlled trials that looked at methods to reduce pain during IUD insertion.3 Reviewers identified four trials from four countries, with 2,204 women studied, that met criteria for review.

Until more studies are completed on regimens for pain during IUD insertion, the ideal intervention is unknown, says the review's lead author, Rebecca Allen, MD, MPH, assistant professor in the Department of Obstetrics and Gynecology at the Warren Alpert Medical School of Brown University in Providence, RI.

In the Cochrane Review, results of two studies that looked at use of the NSAID ibuprofen at doses of 400 mg and 600 mg indicate the drug did not help to reduce pain during IUD insertion.2,4 Whether higher doses would have been effective is unknown, the Cochrane reviewers note.

While naproxen, another NSAID, might help with pain in the first two hours after IUD insertion, the trial which examined its effectiveness used the Dalkon Shield, a larger IUD that is no longer available.5

Allen says it is reasonable to offer women NSAIDs prior to insertion, especially higher doses, such as 600-800 mg of ibuprofen. Although the treatment might not reduce pain during the insertion itself, it might reduce cramping pain post-insertion, she notes.

Findings from one study that did not meet inclusion criteria for the Cochrane Review suggest that lidocaine gel might offer pain relief during IUD insertion. The trial examined application of 2% lidocaine gel; application of the gel to the cervix one minute prior to insertion was more effective than no treatment in reducing pain with IUD insertion. Of 44 women in the 2% lidocaine gel arm, 29 reported moderate to severe pain, compared with 36 women of 38 in the no-treatment arm (odds ratio 0.11; 95% confidence interval 0.02 to 0.51).6 Topical lidocaine gel merits further study with proper methods, the Cochrane Review team concludes.

Misoprostol under review

Intrauterine contraceptive use is expanding in the United States and is now routinely recommended for nulliparous women. The US Medical Eligibility Criteria for Contraceptive Use ranks use of the Copper-T IUD (ParaGard Copper T380A IUD, Teva Women's Health, Woodcliff Lake, NJ) and the levonorgestrel intrauterine system (Mirena IUS, Bayer HealthCare Pharmaceuticals, Wayne, NJ) as a "2" — a condition for which the advantages of using the method generally outweigh the theoretical or proven risks.7

However, the cervix of a nulliparous woman has a smaller diameter, which can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, research is eyeing its use in IUD insertion, particularly among nulliparous women.

A 2007 Swedish study included in the Cochrane Review looked at the use of misoprostol in IUD insertions among nulliparous women.8 The trial included 80 nulliparous women who requested an IUD; patients were allocated randomly to receive sublingually 400 mcg misoprostol and 100 mg diclofenac, or 100 mg diclofenac alone, one hour prior to IUD insertion. Study results indicate that misoprostol did not help to reduce pain during IUD insertion in the nulliparous women; however, the study was not focused on women's pain but rather the ease of placing the IUD from the provider's perspective.8 At this point, the routine use of misoprostol for cervical ripening prior to IUD insertion in nulliparous women to reduce pain is not supported by the literature, says Allen.

Six study sites in the United States are now aiming to determine whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of the trial will be contributed to a prospective meta-analysis on the subject, David Turok, MD, assistant clinical professor in the Department of Obstetrics and Gynecology at the University of Utah in Salt Lake City.

Turok is heading the trial site at the University of Utah. Other investigators include Alison Edelman, MD, MPH, associate professor in the Department of Obstetrics/Gynecology at Oregon Health and Science University in Portland; Eve Espey, MD, MPH, associate professor of obstetrics and gynecology at the University of New Mexico in Albuquerque; Eva Lathrop, MD, MPH, assistant professor in Emory University School of Medicine's Department of Gynecology and Obstetrics in Atlanta; Pamela Lotke, MD, MPH, assistant professor of clinical obstetrics and gynecology at the University of Arizona in Tucson, and Stephanie Teal, MD, MPH, associate professor of obstetrics and gynecology and pediatrics at the University of Colorado, Denver School of Medicine.

The study intervention is 400 mcg of misoprostol inserted vaginally or buccally, whatever method is most acceptable to the patient, says Turok. The drug is administered up to 24 hours before IUD insertion, and both types of IUDs will be included in the analysis. The study's primary outcome is the availability to insert the IUD without adjunctive measures, which includes dilation of the cervix, ultrasound guidance, or administration of additional pain medication. Four of the sites are enrolling patients, says Turok. Results of one site's study were presented at the Reproductive Health 2010 conference in September. A total of 36 women completed the study, with the misoprostol group demonstrating a trend toward a more painful insertion. Provider-reported ease of placement was no different between groups. The misoprostol group had more pre-insertion symptoms, such as nausea and cramping than the placebo group (50% versus 16%).9

Researchers don't yet have the definitive answer yet on use of misoprostol in IUD insertions in nulliparous women, says Turok. "We are making progress on getting the answer, though, which is good," he states.


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