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Letter to the Editor| Volume 34, ISSUE 4, P576, August 2021

Can a Three-Arm RCT With Two Active Drugs Have One Placebo?

  • Ben W. Mol
    Correspondence
    Address correspondence to: Prof Ben W. Mol, Department of Obstetrics and Gynaecology, Monash Medical Centre, 246 Clayton Road, Clayton Victoria 3168, Australia
    Affiliations
    Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia
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Published:March 22, 2021DOI:https://doi.org/10.1016/j.jpag.2021.02.106
      Dr. Ashour and colleagues
      • Ashour ASA
      • El Sharkawy M
      • Ali AS
      • et al.
      Comparative efficacy of vaginal misoprostol vs vaginal dinoprostone administered 3 hours prior to Copper T380A intrauterine device insertion in nulliparous women: a randomized controlled trial.
      recently published a randomised clinical trial on the management of intrauterine device (IUD) insertion. In a 3-arm clinical trial, they randomized nulliparous women prior to Copper T380A IUD insertion to pretreatment with vaginal misoprostol, vaginal dinoprostone, or placebo. The active treatments were 1 tablet of misoprostol 200 mg vaginally (Misotac; Sigma Pharma, SAE, Egypt), and one tablet of dinoprostone 3 mg vaginally (Prostin E2, Pharmacia & Upjohn, Puurs, Belgium), respectively. With respect to placebo, the authors write “participants in the placebo group received 1 tablet of placebo vaginally, which was identical to study drugs.”
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      Reference

        • Ashour ASA
        • El Sharkawy M
        • Ali AS
        • et al.
        Comparative efficacy of vaginal misoprostol vs vaginal dinoprostone administered 3 hours prior to Copper T380A intrauterine device insertion in nulliparous women: a randomized controlled trial.
        J Pediatr Adolesc Gynecol. 2020; 33: 559