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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- thickness of the remaining muscular layer (mm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are younger than
- •Clearly diagnosed with CSD.
- •Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
- •The thickness of the remaining muscular layer of CSD was less than 3 mm.
- •The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
- •The medicine conservative treatment is invalid.
- •Refusing or use birth control pills contraindications.
- •No serious medical problems (important viscera function in the normal range).
- •No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.
- •No gynaecology or other malignant tumors.
- •Sign the informed consent.
排除标准
- •Over the age of 40;
- •Indefinite diagnosis.
- •The absence of clinical manifestations of CSD.
- •The presence of menstrual irregularities before cesarean delivery.
- •Coagulation disorders.
- •Malignant tumors.
- •With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- •Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.
- •Use of intrauterine devices.
- •Unwilling to comply with the research plan.
研究组 & 干预措施
VR + 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).
干预措施: GnRHa (Drug)
VR + 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).
干预措施: Vaginal repair of CSD (Procedure)
VR
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).
干预措施: Vaginal repair of CSD (Procedure)
结局指标
主要结局
thickness of the remaining muscular layer (mm)
时间窗: 6 months after vaginal repair of CSD
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
duration of menstruation (day)
时间窗: 6 months after vaginal repair of CSD
The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.
次要结局
- the depth of CSD (mm)(6 months after vaginal repair of CSD)
- the length of CSD (mm)(6 months after vaginal repair of CSD)
- the width of CSD (mm)(6 months after vaginal repair of CSD)
研究者
Xipeng Wang
Professor
Shanghai First Maternity and Infant Hospital