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

Not Applicable

• Conditions: Cesarean Scar Diverticula
• Interventions: Drug: GnRHa; Procedure: Vaginal repair of CSD

• Registration Number: NCT02932761
• Lead Sponsor: Xipeng Wang

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 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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Study First Posted: 2016-10-13
• Last Update Posted: 2016-10-13
• Study Start: 2016-11
• Primary Completion: 2018-01
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR + GnRHa	GnRHa	CSD patients were treated with vaginal repair of CSD in combination with GnRHa (Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom) as a subcutaneous injection (abbreviated as VR + GnRHa). In the group of VR + GnRHa, 2 doses of GnRHa were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).
VR + GnRHa	Vaginal repair of CSD	CSD patients were treated with vaginal repair of CSD in combination with GnRHa (Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom) as a subcutaneous injection (abbreviated as VR + GnRHa). In the group of VR + GnRHa, 2 doses of GnRHa were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).
VR	Vaginal repair of CSD	CSD patients were treated with vaginal repair of CSD in combination with 0.01 ml saline as a subcutaneous injection (abbreviated as VR). In the group of VR, 2 doses of saline were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the depth of CSD (mm)	6 months after vaginal repair of CSD	The depth of CSD is measured by transvaginal ultrasound.
the length of CSD (mm)	6 months after vaginal repair of CSD	The length of CSD is measured by transvaginal ultrasound.
the width of CSD (mm)	6 months after vaginal repair of CSD	The width of CSD is measured by transvaginal ultrasound.

Trial Locations

Locations (1)

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University; 🇨🇳 Shanghai, Shanghai, China