Pregnancy Outcomes Following Hysteroscopic, Laparoscopic and Laparotomic Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pregnancy complications
研究概览
简要总结
The most prevalent genital pathology, uterine fibroids have a detrimental impact on the health of women. Fibroid symptoms are typically more impactful on females and frequently require uterine excision. Although contentious in terms of how it affects pregnancy outcomes, hysteroscopic, laparoscopic, or laparotomic myomectomy has always been a necessary and suitable procedure for the patient's health. Numerous studies have been conducted on the topic, but no clear findings have been reached.
The goal of this observational study is to investigate the pregnancy outcomes after hysteroscopic, laparoscopic, laparotomic myomectomies in female patients affected by fibroids. The main questions it aims to answer are:
To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.
To investigate whether pregnancy outcome is different in relation to time when myomectomy was performed: on a pregnant uterus or on a non-gravid uterus.
If there is a comparison group: Researchers will compare a group of patients unsubmitted to surgery, to see the difference with the operated patients.
Participants will follow up, to evaluate the possible pregnancy complications, the intraoperative complications and other perinatal and post-operative complications.
详细描述
AIMS:
- To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.
- To investigate if pregnancy outcome is different in relation to time when myomectomy was performed: on a gravid uterus or on a non-gravid uterus
Patients enrolled are divided in three major groups:
- Group A: myomectomy outside of pregnancy-A1 hysteroscopic; A2 laparoscopic; A3 laparotomy
- Group B: myomectomy during CS: B1 trans-endometrial; B2 serosal
- Group C: control group with repeated CS
INCLUSION CRITERIA:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women of reproductive age (up to 45 yrs)-all groups
- •women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
- •myomas 30 mm in size and larger (groups A and B)
- •Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 [groups A1, A2, A3 and groups B1 and B2]
- •Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS [group C]
排除标准
- •any previous surgery on reproductive organs except myomectomy
- •any additional operation during cesarean myomectomy procedure except cesarean section
- •history of endometriosis or PID
- •coagulation disorders
- •previous treatment for any malignant disease
- •previous GTD
- •premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation
- •systemic diseases: IBD, MS, DM
研究组 & 干预措施
Treated patiens' Group as Group 1
Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy
干预措施: Myomectomy (Procedure)
Untreated patiens' Group as Group 2
Control group - unoperated patients
结局指标
主要结局
Pregnancy complications
时间窗: 1 year
placental pathology, intraoperative complications, other complications
次要结局
- Intraoperative complications(1 year)