Safety and effectiveness evaluation of a uterine direct visualization system in induced abortion. A multicenter clinical trial.

Journal: Taiwanese journal of obstetrics & gynecology

Volume: 63

Issue: 2

Year of Publication: 2024

Affiliated Institutions:  Department of Obstetrics and Gynecology, School of Medicine Renji Hospital Shanghai Jiaotong University, Shanghai, China. Department of Obstetrics and Gynecology, Beijing Union Medical College Hospital, Beijing, China. Center of Reproductive Medicine, Tongji Medical College, Huazhong University of Science Technology, Wuhan, China. Electronic address: clxiong@sina.com. Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin, China. Department of Gynecology, Zhejiang Provincial Tongde Hospital, Hangzhou, China. Department of Gynecology, Anhui Maternal and Child Health Hospital, Hefei, China. Marketing Center, Chongqing Jinshan Science & Technology (Group) Co., Ltd, Chongqing, China.

Abstract summary 

While the decision of abortion is undeniably complex, there are situations where it becomes a necessary choice. In such circumstances, a secure abortion procedure is essential to safeguard the physical and mental well-being of women. A uterine direct visualization system was designed to fulfill the requirements and this study undertook an assessment of the system's safety and effectiveness within a medical facility setting.Induced abortion requested women in 17 institutions across the country between December 2016 and February 2017 were enrolled. Subjects were separated to the study and control group randomly. Induced abortion was conducted by a uterine direct visualization system and an ultrasound-guided system in the study and control group, respectively. The clinical indexes collected during intra- and post-procedures were analyzed and compared between groups.Overall, 392 and 339 subjects were included in the study and control group, respectively. The baseline demographic and clinical characteristics were similar between two groups. Subjects in the study group had significant smaller number of uterine cavity entry (p < 0.001), less 2-h and 14-days postoperative bleeding (all p < 0.001), and less 14-days postoperative abdominal pain (p < 0.001). Significantly higher ratio of normal menstruation, in terms of incidence and duration after 60-days of operation, was observed in the study group (all p < 0.001).Induced abortion with uterine direct visualization system generate better outcome and less complication than the conventional ultrasound-guided abortion procedures.

Authors & Co-authors:  Zhou Liu Xiong Gu Lv Wang Hou Zhao

Study Outcome 

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Citations : 
Authors :  8
Identifiers
Doi : 10.1016/j.tjog.2024.01.017
SSN : 1875-6263
Study Population
Women
Mesh Terms
Pregnancy
Other Terms
Early pregnancy;Induced abortion;Ultrasound-guided induced abortion;Uterine direct visualization system for induced abortion
Study Design
Study Approach
Country of Study
Publication Country
China (Republic : 1949- )