临床试验/ChiCTR2100054748

ChiCTR2100054748招募中Unknown

The efficacy and safety of MateRegen gel to prevent intrauterine adhesion after surgical evacuation: A prospective randomized controlled trial

N/A`1 个研究点分布在 1 个国家目标入组 172 人开始时间: 2022年1月1日最近更新: 2022年12月4日

试验速览

阶段: Unknown
状态: 招募中
发起方
入组人数: 172
试验地点: 1
主要终点: Presence of intrauterine adhesions

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after surgical evacuation, including both tradition surgical evacuation and USG-MVA, in the treatment of first trimester miscarriage after surgical evacuation.

研究设计

研究类型: Interventional
主要目的: 随机平行对照
盲法: None

入排标准

年龄范围: 18 至 50（—）
性别: Female

入选标准

•1.All women undergoing USG-MVA or traditional surgical evacuation with EVA or D&C for the treatment of early pregnancy loss with gestation < 12weeks;
•2.Women 18 years old or above;
•3.No previous history of IUA/ Ashermans syndrome;
•4.No previous history of therapeutic hysteroscopic surgeries;
•5.Agreeing to use adequate contraception throughout the follow-up period and to attend the follow-up examination according to study protocol.

排除标准

•Previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis);
•Suspicion of molar pregnancy;
•Genital tract malformation;
•Suspicion of active infection or genital tract malignancy or genital tuberculosis;
•Abnormal blood coagulation;
•Inability to tolerate pelvic examination known;
•Suspected intolerance or hypersensitivity to NCH gel or its derivatives like cosmetic products;
•Patient refusal.

研究组 & 干预措施

1

surgical evacuation with NCH gel

2

surgical evacuation alone

结局指标

主要结局

Presence of intrauterine adhesions

时间窗: 8-12 weeks' time from their USG-MVA or surgical evacuation procedure

次要结局

未报告次要终点

研究者

发起方

N/A`

研究点 (1)

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