Author(s)

Donghong Zheng ¹, Qi Feng ², Chaomin Chen ², Zhuojia Li ³

Affiliation(s)

¹ Department of Equipment, Heyuan People's Hospital, Heyuan, 517600, China
² School of Biomedical Engineering, Southern Medical University, Guangzhou, 510515, China
³ Southern Medical University NanFang Hospital, Guangzhou, 510515, China

Corresponding Author

Zhuojia Li

ABSTRACT

Study the clinical effectiveness of Laborvue delivery monitor in Guangzhou Lianyin Medical Technology Co., Ltd., in order to prove that it can reduce unreasonable non-medical indication cesarean section and inappropriate vaginal delivery, realize continuous noninvasive monitoring of multiple parameters of labor process, guide clinical decision and improve natural delivery rate. The design of this research scheme followed the guiding principles of Medical device Test Design. Compared with the main clinical evaluation indexes of LaborPro delivery monitor, the research scheme selected two main clinical evaluation indexes of cervical dilatation and fetal position. The data of control group and experimental group were analyzed by statistical software. There was a linear and highly positive correlation between the data of control group and the data of experimental group. To verify the clinical effectiveness of Laborvue delivery monitor. The clinical research scheme was determined by parallel control trial, the main contents of which were randomization design, incomplete blindness and positive control. The selection criteria and exclusion criteria were established, and the two main clinical evaluation indexes of cervical dilatation and fetal position were selected, and the sample size of each group was set to 95-104. The clinical trial method of Laborvue delivery monitor proposed in this paper has good innovation and applicability, and can be used in future registered clinical trials. 

KEYWORDS

Fetal position, Cervical dilatation, Delivery monitor, Clinical trials

CITE THIS PAPER

Donghong Zheng, Qi Feng, Chaomin Chen, Zhuojia Li, Study on Clinical Experimental Methods of the Laborvue Delivery Monitor. MEDS Clinical Medicine (2022) Vol. 3: 1-8. DOI: http://dx.doi.org/10.23977/medsc.2022.030401.

REFERENCES

[1] Huang Ming, Chen Zhuli, Long Lijia, Wan Li. Objective: to explore the application value of intrapartum b-ultrasound monitoring in pregnant women during vaginal delivery. Sichuan Journal of Anatomy, 2021, (01): 15-18. 
[2] Sharla Cheung, Yin Ailan, Zhong Mei, Huang Xiaoli, Peng Cheng, Li Jing, Wang Liping, Wang Zhijian, Gao Yunfei. Study on the relationship between spatial positioning system and traditional vaginal digital examination for monitoring cervical dilatation and fetal head descent. Chinese journal of practical gynecology and obstetrics, 2015, (02): 160-164. 
[3] Guo Wei, Jin Quanlong. Predictive value of cervical morphological parameters measured by perineum ultrasound on parturition time. Journal of clinical ultrasound medicine, 2017, (11): 782-784.
[4] Sharla Cheung. Application of Laborpro digital labor monitor in pelvic measurement and labor monitoring. Master's degree thesis. Southern Medical University, 2015. 
[5] Wang Yuping, Lu Xiaoxing, Wang Kai. The invention relates to a tire head direction measuring device and a method thereof. China, authorization of invention, CN109717906 B. 2020.5.08.
[6] Chen Qiru. Study on quantitative monitoring of the relationship between fetal head and pelvis and its three-dimensional display technique. Master’s degree thesis. Jinan University, 2016.
[7] Zhang Qiang, Meng Ping, Shan Ai Lian. Considerations on inclusion and exclusion criteria in drug clinical trial protocols. Clinical Pharmacology, 2017, (02): 99-101. 
[8] Liu Xu. Clinical trial design and data processing (II)-three principles of clinical trial design. Journal of Difficult Diseases, 2002, (03): 186-187. 
[9] Huang Yanyan. Progress in research on ultrasonic assessment of cervical maturity. Medical theory and practice, 2020, (03): 382-384.
[10] Haberman S, Paltieli Y, Gonen R, Ohel G, Ville Y, Nizard J. Association between ultrasound-based assessment of fetal head station and clinically assessed cervical dilatation. Ultrasound in obstetrics & gynecology: Official journal of International Society of Ultrasound in Obstetrics and Gynecology, 2011, 37(6):112-118.
[11] Liu Yisong. Realization of common sample size estimation methods and comparison of some methods based on PASS and Sas software. Master's degree thesis. PLA Academy of Military Medical Sciences, 2016.
[12] Wang Yuanyuan and Sun Ruihua. Estimation of sample size for non-inferiority, equivalence and superiority tests in clinical trials with PASS software. Chinese Journal of Epidemiology, 2016, (05): 741-744.

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