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Expression of Concern| Volume 120, 109973, April 2023

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A randomized double blinded clinical trial to explore the clinical outcomes of vaginal isonicotinic acid hydrazide (INH) administration six hours prior to T380A intrauterine device insertion in persons delivered only by cesarean delivery. Contraception. 2022 Feb 18:9788. doi: 10.1016/j.contraception.2022.01.019. Epub ahead of print.

      Concern has been raised about the article listed above. The paper underwent external statistical review and no statistical concerns were identified.
      It has come to the attention of the Editor that a total of eight clinical trials were registered by the institution in August 2020 on clinicaltrials.gov. (https://clinicaltrials.gov/ct2/results?cond=isonicotinic±acid±hydrazide&term=&cntry=EG&state=&city=&dist=) This volume is of concern and the Editor believes readers should be aware of the concern when assessing the paper.
      NCT04500015  Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion.    130 participants   Sept 2000 – June 2021. Completed; registered August 5, 2020
      NCT04500522 Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients. 150 participants. Sept 2000 – June 2021. Completed. Registered August 5, 2020
      NCT04499989 Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion 220 participants. Sept 2000 – June 2021. Completed. Registered August 5, 2020
      NCT04500470 Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography. 200 participants. Sept 2000 – July 2021. Completed, Registered August 5, 2020
      NCT04500496 Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy 220 participants Started September 1 2020. Recruiting. Registered August 5, 2020
      NCT04500002 Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion. Not yet recruiting. Registered August 5, 2020
      NCT04499976 Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage. Not yet recruiting. Registered August 5, 2020
      NCT04505943 Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion Not yet recruiting. Registered August 10, 2020

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