Clinical Trial: Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of the Therapeutic Effects of Vaginal Repair and Vaginal Repair Combined With GnRHa in the Treatment of Cesarean Scar Diverticula: a Randomized Clinical Trial

Brief Summary: Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. The investigators have previously demonstrated that vaginal repair of CSD was an relative effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months post vaginal repair. Postoperative menstruation may contribute to surgical site infections, which may subsequently affect the healing of uterine scars. Treatment CSD patients with gonadotropin-releasing hormone agonist (GnRHa) may has the potential to improve therapeutic effects of vaginal repair. Therefore, the current multiple-center randomized controlled trial was designed to evaluate whether the application of GnRHa in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.

Detailed Summary: Postoperative menstruation may contribute to surgical site infections, an inflammatory environment, congestion at the site of the suture, immune cell infiltration, and other effects and may subsequently affect the healing of uterine scars. It is reasonable to hypothesize that delaying the postoperative menstrual recovery period may allow uterine scars to heal without the inflammatory reaction caused by menstruation. Treatment with gonadotropin-releasing hormone agonist (GnRHa) has the ability to suppress follicle-stimulating hormone (FSH) and luteinizing hormone (LH) release, thereby maintaining low estrogen levels and causing temporary amenorrhea. A prolonged menstrual recovery period may be achieved after GnRHa administration. Vaginal repair of CSD combined with GnRHa may improve the therapeutic effects of treatment of CSD. Therefore, the randomized study was designed to evaluate whether the application of GnRHa in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
Sponsor: Xipeng Wang

Current Primary Outcome:

  • thickness of the remaining muscular layer (mm) [ Time Frame: 6 months after vaginal repair of CSD ]
    The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
  • duration of menstruation (day) [ Time Frame: 6 months after vaginal repair of CSD ]
    The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the length of CSD (mm) [ Time Frame: 6 months after vaginal repair of CSD ]
    The length of CSD is measured by transvaginal ultrasound.
  • the width of CSD (mm) [ Time Frame: 6 months after vaginal repair of CSD ]
    The width of CSD is measured by transvaginal ultrasound.
  • the depth of CSD (mm) [ Time Frame: 6 months after vaginal repair of CSD ]
    The depth of CSD is measured by transvaginal ultrasound.


Original Secondary Outcome: Same as current

Information By: Shanghai First Maternity and Infant Hospital

Dates:
Date Received: October 8, 2016
Date Started: November 2016
Date Completion: July 2018
Last Updated: October 11, 2016
Last Verified: October 2016