Study of Uterine Stents Compared to Uterine Rings, Balloons, and Gel to Prevent and Treat Intrauterine Adhesions in Women Ages 20 to 40

What This Trial Is About

Researchers are evaluating the effect of uterine stents in preventing intrauterine adhesions after intrauterine surgery and whether these stents meet safety standards for clinical use. This prospective, multicenter, randomized controlled trial involves 200 women aged 20 to 40 years who have intrauterine adhesions and require surgery due to fertility needs or menstrual blood drainage obstruction. The study compares two groups to assess the prevention and treatment of these adhesions. One group receives uterine stents placed inside the uterine cavity following hysteroscopic adhesion separation surgery. The other group receives a combination of intrauterine rings, balloons, and sodium hyaluronate gel after the same surgery. The stents are adjusted with a hysteroscope, while the second group uses a Foley catheter balloon and hyaluronic acid gel, with the catheter removed one day post-surgery. After three cycles of artificial menstruation, patients are hospitalized for a hysteroscopy review. Participants will undergo evaluations including hysteroscopy at 12 months after surgery to measure the rate of intrauterine adhesions. The study involves monitoring the participants through these procedures to assess safety and effectiveness. The total follow-up period includes the initial surgery, three artificial menstrual cycles, and the final hysteroscopy examination to determine treatment outcomes.

To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial