Development of an Informed Consent Form for Intrauterine Device (IUD) Insertion Using the Delphi Method

Abstract

Background & aim: The intrauterine device (IUD) is a widely used reversible contraceptive with risks such as expulsion or infection, necessitating informed consent. There is a gap in studies on informed consent forms for IUD placement. This study uses the Delphi method to create a comprehensive consent form tailored for IUD insertion.Methods: This research was conducted at Yazd University of Medical Sciences (2019-2018) using the Delphi technique. Thirty experts, including gynecologists, midwives, and reproductive health specialists, participated in three Delphi rounds. A draft consent form was prepared based on literature studies, previous research, and expert opinions. The Delphi rounds aimed to establish necessity, determine item importance, and gauge expert agreement.Results: Three Delphi rounds were conducted with 28, 24, and 24 participants, respectively. The consent form, designed in nine areas, was reviewed and refined. Items with 75% agreement or more were accepted in the first round, while those with 25% agreement or less were removed. The second and third rounds considered agreement levels above 75% and change rates below 15%. An acceptable consensus above 51% was reached, resulting in a finalized consent form with five sections: demographic characteristics, general IUD placement features, contraindications, patient responsibilities, and declaration of consent.Conclusion: Implementing the informed consent form in the clinical process of IUD placement is essential for respecting client autonomy, minimizing risks, addressing clinical consequences, and fulfilling legal responsibilities. Research on the use of the designed form in patients desiring an IUD is suggested.

Keywords

• informed consent
• iud insertion
• delphi technique