Analysis Of Expulsion Rate And Evaluation Of Acceptability On Intrauterine Device In Chinese Reproductive Women

Contraceptives are a special series of drugs and medical devices used for contraception (interference or blocking pregnancy process) in order to birth control. Intrauterine device (IUD) is the most widely contraceptive method. It was estimated that there were around 130 million Chinese women using IUD for contraception, which was 80% of the user in the world. Both TCu380A and MLCu375 are recommended by the WHO due to their high efficacy and safety, marketed in 1984 and 1974 respectively. YuangongCu-220 and YuangongCu-365 IUDs are independently developed in China, marketed as new generation of copper-bearing indomethacin-releasing intrauterine device in 2000 and 2002 respectively.Currently, there are few mulcentre and large randomized controlled trial (RCT) comparing efficacy of TCu380A and MLCu375, and the comparing results between the two IUDs from current RCTs are inconsistent with that of foreign RCT. No RCT on YuangongCu-365 IUD to date is available. IUD expulsion, as an important evaluation index of continuation of IUD, can cause unplanned pregnancy, especially unnoticed expulsion, and affect women's physical and mental health. To our knowledge, however, few study has been specifically to examine the risk factors for expulsion.The acceptability of contraceptives is largely affected by safety and efficacy of contraceptive methods as well as change in their quality of life, such as their personal subjective experience, sexual life, and other aspects. Currently, there are only a few foreign prospective studies addressing the impact of combined oral comtraceptive (COC) on quality of life, and in China, there are only one similar study in Hong Kang. Moreover, results of these studies are inconsistent in different population and different quality-of-life questionnaires.The objectives of our study were to perform a secondary analysis used the data from a national multicenter large RCT of three IUDs (YuangongCu-365, TCu380A and MLCu375), compare the expulsion rates of three IUDs and explore factors that may affect early expulsion; compared with Marvelon COC, we firstly tried to evaluate the impact of YuangongCu-220 IUD on quality of life in women of Jiangsu Province by a self-administered quality of life questionnaire; We hope provide guidance for the contraceptive informed choice and quality care in family planning.PartⅠAnalysis of expulsion rate on three IUDs in Chinese reproductive womenIt was estimated that there were around 130 million Chinese women using IUD for contraception, which was 80% of the user in the world. The early discontinuation of IUD was a great problem in reproductive health. Expulsion, as one of the discontinuation reasons of IUD, is an important evaluation index of continuation of IUD. Previous RCTs demonstrated that expulsion is one of the first three reasons in all discontinuation for medical reasons. Expulsion can cause unplanned pregnancy, especially unnoticed expulsion, and affect women's physical and mental health. To our knowledge, however, few study has been specifically to examine the risk factors for expulsion.The project on national multicenter large RCT of three IUDs (YuangongCu-365, TCu380A and MLCu375) collected baseline information by questionnaire, provided healthy screening for women meting the inclusive criteria, and assessed that women will use which contraceptive method according to personal voluntary principle and medical screening criteria in 6 centers. Eligible women were allocated randomly YuangongCu-365, Tcu380A or MLCu375 group with equal probability. Every woman was inserted IUD by trained doctor in family planning guidance station or hospital. Follow-up visits were scheduled for 1-3, 6 and 12 months after IUD insertion, and status of side effects and termination were recorded in follow-up tables. The objectives of our study were to perform a secondary analysis used the data from the project, compare the expulsion rates of three IUDs and explore the factors that may affect expulsion. The main results were as follows:1. The proportions of the number of YuangongCu-365, TCu380A and MLCu375 after 6-month of IUD insertion in the number after 12-month were 60.56%(43/71),67.39%(62/92)and 68.29%(168/246)respectively. The one year expulsion rates of YuangongCu-365, TCu380A and MLCu375 were 0.31%, 0.46% and 1.39% respectively, and appeared significant difference (P<0.0001); The multiple comparisons of one year expulsion rate among three IUDs groups showed: the expulsion rate was similar in YuangongCu-365 and TCu380A MLCu375 groups (PBon_adj=0.2945), and was significantly lower in the two groups than in MLCu375 group(PBon_adj <0.0001).2. The gross cumulative expulsion rates (per 100 women) of YuangongCu-365, TCu380A and MLCu375 after 1 year of IUD insertion were 1.05(0.81,1.29),1.40(1.12,1.68) and 3.80(3.34,4.27) respectively. The course of expulsion among three groups were significant different (χ2=147.47,P<0.0001); The gross cumulative expulsion rates after 1 year of IUD insertion were similar in YuangongCu-365 and TCu380A(PBon_adj=0.1962), and were significantly lower in the two groups than in MLCu375 group(PBon_adj <0.0001).3. The gross cumulative expulsion rates (per 100 women) of YuangongCu-365, TCu380A and MLCu375 after 3-month of IUD insertion were 0.32(0.19, 0.45), 0.47(0.31, 0.63) and 1.43(1.15, 1.71). The rates were no significant different between YuangongCu-365 and TCu380A groups (u=1.41 , PBon_adj=0.476), and were significantly lower in the two groups than MLCu375 group (u=5.95,PBon_adj<0.001;u=7.09,PBon_adj<0.001). No significant difference was found in gross cumulative expulsion rates after 6- and 12-month of IUD insertion between YuangongCu-365 and TCu380A groups, and the rates were significantly higher in the two groups than in MLCu375 group. 4.Analytic result of Cox regression adjusted center effect showed that young age, dysmenorrheal, use of MLCu375 compared with YuangongCu-365 and TCu380A , less follow-up time and side effect without medical treatment were probably risk factor of expulsion.Conclusion: The gross cumulative expulsion rate after 1 year of IUD insertion in YuangongCu-365 group was similar with that in TCu380A, and was significantly lower than that in MLCu375 group. And the rate in TCu380A group was also significantly lower than that in MLCu375 group, but foreign study results showed that the rates were similar between the two groups. The gross cumulative expulsion rate of the TCu380A group in our study was lower than foreign results, and the rate of the MLCu375 group was similar with foreign results. Age, dysmenorrheal, IUD type and medical treatment were significant factor that may affect early expulsion, and the effect of follow-up time on early expulsion was still under debate.PartⅡEvaluation of acceptability on YuangongCu-220 IUD and Marvelon COC in reproductive women of Jiangsu ProvinceQuality of life is becoming important with development of social economy and improvement of life level. The use of contraceptive methods has an important influence on women's quality of life. Women's choices of contraceptive methods are largely affected by safety and efficacy of contraceptive methods as well as change in their quality of life, such as their personal subjective experience, sexual life, and other aspects. Currently, there are only a few foreign prospective studies addressing the impact of combined oral comtraceptive (COC) on quality of life, and in China, there are only one similar study in Hong Kang. Moreover, results of these studies are inconsistent in different population and different quality-of-life questionnaires. We performed a 12-month prospective observation for the YuangongCu-220 IUD and COC users. Before contraceptive method use, self-administered quality-of-life questionnaires were completed by the subjects. Subjects with any reason for discontinuing contraceptive methods within 12 months and subjects still in observation at 12 months were required to fill up the same questionnaires. Follow-up visits were scheduled for 1-3, 6 and 12 months after initial contraceptive method use, and status of side effects and termination were recorded in follow-up tables. We analyzed the change of quality-of-life scores in women before and after contraceptive use. The main results were as follows:1. All item scores except for work/school/labor, household activities and leisure time activities, had improved statistically from baseline in YuangongCu-220 IUD users (P<0.05). Significant score changes of physical health, mood, work/school/labor, living situation, vision, general well-being and overall satisfaction, significant improvements were noted after COC use in women (P<0.05).2. The proportion of YCu220 IUD users with total quality-of-life scores≥57 increased from 4.40% to 12.04%, and the proportion of women with total quality-of-life scores≤45 dropped from 23.15% to 9.95%. But for COC users, the proportion of women with total quality-of-life scores≥57 before and after COC use were 11.50% and 11.79%, respectively; the proportion of women with total quality-of-life scores≤45 increased from 9.09% to 11.65%.3.No matter what the contraceptive history was, every subgroup stratified by contraceptive history of YuangongCu-220 IUD users had a significantly increasing total quality-of-life scores before and after YuangongCu-220 IUD use (P<0.05) (Table 4), and the differences of change were significant among different sub-groups (F=3.09, P=0.0265). YuangongCu-220 IUD users without prior contraceptive history had the lowest difference of change (0.89±6.53). The total quality-of-life scores in COC users without prior contraceptive history did not increase significantly before and after COC use. But the total quality-of-life scores in COC users with past IUD use increased significantly (P<0.05).Conclusion: YuangongCu-220 IUD had a significantly greater improvement of overall quality of life, and.had a better acceptability in these rural women of Jiangsu Province; this type of COC particularly improved part of quality of life in these women, but the accepability was inferior to COC first-time users in developed countries; Compared to women without contraceptive use history, women with past OC and/or IUD use had a significantly higher improvement in the total quality-of-life scores, and had a better acceptability.