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

Autor: Xiaofei Zhou, Xinyan Liu, Chengliang Xiong, Xiangying Gu, Wen Lv, Banglan Wang, Chunmei Hou, Yong Zhao
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Taiwanese Journal of Obstetrics & Gynecology, Vol 63, Iss 2, Pp 214-219 (2024)
Druh dokumentu: article
ISSN: 1028-4559
DOI: 10.1016/j.tjog.2024.01.017
Popis: Objectives: 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. Materials and methods: 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. Results: 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
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