Clinical Trial: Intrauterine Balloon Therapy to Prevent the Recurrence of Intrauterine Adhesions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy of Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Reformation Following Hysteroscopic Adhesiolysis

Brief Summary: In this prospective, randomized, controlled study, the investigators wish to determine the efficacy of intrauterine balloon (IUB) dilatation in the prevention of adhesion reformation when compared with the conventional management.

Detailed Summary:

Patients

The patients will be recruited from the Hysteroscopy Center of the Fuxing Hospital, Beijing, China. Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations, including a detailed history of the menstrual pattern, any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography. The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). The inclusion criteria include [1] women aged 18-40 years; [2] moderate to severe intrauterine adhesion (AFS score≥5); [3] first episode of hysteroscopic adhesiolysis in FuXcing hospital; [4] written consent obtained; and [5] agreement to have second-look and an optional third-look hysteroscopy. The exclusion criteria include [1] minimal adhesion (AFS score <5) and [2] previous hysteroscopic adhesiolysis in FuXing hospital.

Study Design

After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: [1] having a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis; [2] the control group without any additional treatment. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.

Power Calculation

On the basis of the results of the two published retrospective cohort studies comparing the balloon and hormone therapy group (control group) in the prevention of adhesion refo
Sponsor: Fu Xing Hospital, Capital Medical University

Current Primary Outcome: The degree of intrauterine adhesions and AFS score [ Time Frame: at 4 and 8 weeks post-op ]

The degree of intrauterine adhesions and AFS score reduction at second look and third look hysteroscopy


Original Primary Outcome: Same as current

Current Secondary Outcome: menstrual pattern [ Time Frame: at 4 months post-op ]

The menstrual pattern before and after surgery and the need for re-operation


Original Secondary Outcome: Same as current

Information By: Fu Xing Hospital, Capital Medical University

Dates:
Date Received: April 24, 2017
Date Started: April 30, 2017
Date Completion: December 31, 2018
Last Updated: May 2, 2017
Last Verified: May 2017