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

Cesarean Scar Diverticula Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02932761
• Other study ID #: CSD-001
• Status: Not yet recruiting
• Phase: N/A
• First received: October 8, 2016
• Last updated: October 11, 2016
• Start date: November 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xipeng Wang, M.D., Ph.D.,
• Phone: 86-13817806602
• Email: xipengwang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Patients are younger than 40.

2. Clearly diagnosed with CSD.

3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).

4. The thickness of the remaining muscular layer of CSD was less than 3 mm.

5. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.

6. The medicine conservative treatment is invalid.

7. Refusing or use birth control pills contraindications.

8. No serious medical problems (important viscera function in the normal range).

9. No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.

10. No gynaecology or other malignant tumors.

11. Sign the informed consent.

Exclusion Criteria:

1. Over the age of 40;

2. Indefinite diagnosis.

3. The absence of clinical manifestations of CSD.

4. The presence of menstrual irregularities before cesarean delivery.

5. Coagulation disorders.

6. Malignant tumors.

7. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).

8. Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.

9. Use of intrauterine devices.

10. Unwilling to comply with the research plan.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Scar Diverticula
• Diverticulum

Intervention

Drug:
• GnRHa
Two doses of GnRHa were administered by subcutaneous injection. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure.

Procedure:
• Vaginal repair of CSD
The procedure of vaginal repair of CSD was shown as following. The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached. The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed. A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.

Locations

Country	Name	City	State
China	Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xipeng Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thickness of the remaining muscular layer (mm)	The thickness of the remaining muscular layer is measured by transvaginal ultrasound.	6 months after vaginal repair of CSD	No
Primary	duration of menstruation (day)	The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.	6 months after vaginal repair of CSD	No
Secondary	the length of CSD (mm)	The length of CSD is measured by transvaginal ultrasound.	6 months after vaginal repair of CSD	No
Secondary	the width of CSD (mm)	The width of CSD is measured by transvaginal ultrasound.	6 months after vaginal repair of CSD	No
Secondary	the depth of CSD (mm)	The depth of CSD is measured by transvaginal ultrasound.	6 months after vaginal repair of CSD	No