BACKGROUND: Barriers to intrauterine device (IUD) use in nulliparous women include fear of pain with insertion and provider perception of difficulty with insertion. The goal of this study was to evaluate whether misoprostol prior to IUD insertion in nulliparous women eased insertion and decreased pain. STUDY DESIGN: This was a double-blinded, randomized, controlled trial. Nulliparous women requesting an IUD were randomized to buccal placement of 400-mcg misoprostol or placebo. Provider ease of insertion and patient-reported pain were measured using a 100-mm visual analogue scale. RESULTS:Seventy-three subjects completed the study. Baseline characteristics were similar between groups. Provider perception of ease of insertion was not different between study and control groups (28.97 mm, 22.33 mm, p=.18). Pain immediately prior to IUD insertion (10.84 vs. 2.11; p=.003) and after IUD insertion (46.50 vs. 35.14; p=.040) was higher for those in the study group compared to the control group. CONCLUSION: This study demonstrates that it is not helpful to provide misoprostol for cervical ripening prior to insertion of IUDs as it does not improve ease of insertion for provider or decrease reported pain for the woman, and it may increase women's pain experience with insertion. IMPLICATION STATEMENT: Our study demonstrates that providers do not perceive nulliparous IUD insertion as difficult; women do experience pain with insertion but find the experience acceptable. The addition of misoprostol for cervical ripening prior to insertion does not ease insertion for providers and increases the pain level experienced by women.
RCT Entities:
BACKGROUND: Barriers to intrauterine device (IUD) use in nulliparous women include fear of pain with insertion and provider perception of difficulty with insertion. The goal of this study was to evaluate whether misoprostol prior to IUD insertion in nulliparous women eased insertion and decreased pain. STUDY DESIGN: This was a double-blinded, randomized, controlled trial. Nulliparous women requesting an IUD were randomized to buccal placement of 400-mcg misoprostol or placebo. Provider ease of insertion and patient-reported pain were measured using a 100-mm visual analogue scale. RESULTS: Seventy-three subjects completed the study. Baseline characteristics were similar between groups. Provider perception of ease of insertion was not different between study and control groups (28.97 mm, 22.33 mm, p=.18). Pain immediately prior to IUD insertion (10.84 vs. 2.11; p=.003) and after IUD insertion (46.50 vs. 35.14; p=.040) was higher for those in the study group compared to the control group. CONCLUSION: This study demonstrates that it is not helpful to provide misoprostol for cervical ripening prior to insertion of IUDs as it does not improve ease of insertion for provider or decrease reported pain for the woman, and it may increase women's pain experience with insertion. IMPLICATION STATEMENT: Our study demonstrates that providers do not perceive nulliparous IUD insertion as difficult; women do experience pain with insertion but find the experience acceptable. The addition of misoprostol for cervical ripening prior to insertion does not ease insertion for providers and increases the pain level experienced by women.
Authors: Laureen M Lopez; Alissa Bernholc; Yanwu Zeng; Rebecca H Allen; Deborah Bartz; Paul A O'Brien; David Hubacher Journal: Cochrane Database Syst Rev Date: 2015-07-29