剖宫产术后即刻放置固定式宫内节育器脱落率及其影响因素前瞻性队列研究  

Expulsion rate and influencing factors of GyneFix postpartum intrauterine device placed immediately after cesarean section:a prospective cohort study

作　　者：陈星 侯桂芳 张红萍 杨恒 林淑娟 甘涛 杨卫华 施春晖 任卫娟[9] 徐英芹 尹保民[11] 陈婷婷 甘玉杰[13] 张媛 张妍[1] 程利南 车焱 Chen Xing;Hou Guifang;Zhang Hongping;Yang Heng;Lin Shujuan;Gan Tao;Yang Weihua;Shi Chunhui;Ren Weijuan;Xu Yingqin;Yin Baomin;Chen Tingting;Gan Yujie;Zhang Yuan;Zhang Yan;Cheng Linan;Che Yan(NHC Key Lab of Reproduction Regulation Shanghai Engineering Research Center of Reproductive Health Drug and Devices Institute for Public Health and Policy Research,Shanghai Institute for Biomedical and Pharmaceutical Technologies School of Public Health,Fudan University,Shanghai 200237,China;Department of Obstetrics,the Second People's Hospital of Huadu District,Guangzhou 510800,China;Department of Obstetrics,Wenzhou People's Hospital,Wenzhou 325000,China;Department of Obstetrics,Shenzhen Luohu Maternal and Child Health Hospital,Shenzhen 518001,China;Department of Obstetrics,Jiangmen Maternity and Child Health Care Hospital,Jiangmen 529000,China;Department of Obstetrics,Jun'an Hospital,Shunde Hospital of Guangzhou University of Chinese Medicine,Guangzhou 528300,China;Department of Obstetrics,University of Chinese Academy of Sciences-Shenzhen Hospital,Shenzhen 518000,China;Department of Obstetrics,Yuhuan Hospital of Traditional Chinese Medicine,Yuhuan 317699,China;Department of Obstetrics,Yangzhou Maternal and Child Health Hospital,Affiliated Hospital of Yangzhou University,Yangzhou 225000,China;Department of Obstetrics,Laizhou Maternity and Child Healthcare Hospital,Laizhou 261400,China;Department of Obstetrics,Zhuhai Maternal and Child Health Hospital,Zhuhai 519000,China;Department of Obstetrics,the First People's Hospital of Longwan District,Wenzhou 325024,China;Department of Obstetrics,Boai Hospital of Zhongshan,Zhongshan 528400,China;Department of Obstetrics,Yangjiang Maternal and Child Health Hospital,Yangjiang 529500,China;NHC Key Lab of Reproduction Regulation Shanghai Engineering Research Center of Reproductive Health Drug and Devices Institute for Public Health and Policy Research,Shanghai Institute for Biomedical and Pharmaceutical Technologies,Shanghai 200237,China)

机构地区：[1]国家卫生健康委员会计划生育药具重点实验室,上海生殖健康药具工程技术研究中心,上海市生物医药技术研究院公共健康与政策研究所复旦大学公共卫生学院,上海200237 [2]广州市花都区第二人民医院妇产科,广州510800 [3]温州市人民医院妇产科,温州325000 [4]深圳市罗湖区妇幼保健院妇产科,深圳518001 [5]江门市妇幼保健院妇产科,江门529000 [6]广州中医药大学顺德医院附属均安医院妇产科,佛山528300 [7]中国科学院大学深圳医院(光明)妇产科,深圳518000 [8]玉环中医院妇产科,玉环317699 [9]扬州市妇幼保健院妇产科,扬州225000 [10]莱州市妇幼保健院妇产科,莱州261400 [11]珠海市妇幼保健院妇产科,珠海519000 [12]温州市龙湾区第一人民医院妇产科,温州325024 [13]广东省中山市博爱医院妇产科,中山528400 [14]广东省阳江市妇幼保健院妇产科,阳江529500 [15]国家卫生健康委员会计划生育药具重点实验室,上海生殖健康药具工程技术研究中心,上海市生物医药技术研究院公共健康与政策研究所,上海200237

出　　处：《中华生殖与避孕杂志》2024年第1期37-43,共7页Chinese Journal of Reproduction and Contraception

摘　　要：目的探讨剖宫产术后即刻放置固定式宫内节育器(postpartum intrauterine device,PPIUD)1年内的脱落率及其影响因素。方法采用前瞻性队列研究方法,2017年9月至2020年11月期间在全国4个省市14家医疗机构招募自愿于剖宫产术后即刻(胎盘娩出后10 min内)放置固定式PPIUD的妇女为研究对象,通过问卷收集研究对象术前、术中和术后24 h相关信息,并于产后42 d、3个月、6个月和12个月进行门诊随访,了解固定式PPIUD脱落和意外妊娠等信息。采用寿命表和Cox回归模型分析累积脱落率以及相关影响因素。结果共招募470名研究对象,461名(98%)为本文提供了合格数据,剖宫产术后1年内固定式PPIUD累积脱落率为8.4%(95%CI:7.0%~9.8%)。多因素Cox回归分析显示,分娩年龄>35岁放置固定式PPIUD后1年内脱落率显著低于年龄<25岁女性(HR=0.16,95%CI:0.04~0.64),且均未显示剖宫产既往史和哺乳方式与固定式PPIUD脱落风险均显示有统计学关联(均P>0.05)。但脱落率存在医院聚集性。分析显示,产后1年累积避孕失败比尔指数为2.37(95%CI:1.09~4.50)/100人年,避孕失败与产妇年龄、哺乳和剖宫产史均无统计学关联(均P>0.05)。结论剖宫产术后即刻放置固定式PPIUD 1年累积脱落率为8.4%,低龄是其脱落的高危因素。建议加强该PPIUD使用者脱落风险识别的指导,一旦脱落,应及时更换或用其他高效避孕方法。建议加强服务提供者放置技术培训。Objective To investigate the expulsion rate of GyneFix postpartum intrauterine device(PPIUD)placed immediately after cesarean section within one year and its influencing factors.Methods A prospective cohort study was conducted.Women who volunteered to use a GyneFix PPIUD placed immediately after cesarean section(within 10 min after placenta delivery)for postpartum contraception were recruited from September 2017 to November 2020.The relevant information was collected through questionnaires before,during and 24 h after cesarean section.Outpatient follow-up was conducted at 42 d,3 months,6 months and 12 months after delivery to obtain information on expulsion of GyneFix PPIUD and unwanted pregnancy.Life table and Cox regression model were used to analyze the cumulative expulsion rate and related influencing factors.Results A total of 470 subjects were recruited and 461(98%)subjects were eligible for this study.The cumulative expulsion rate of GyneFix PPIUD within one year after cesarean section was 8.4%(95%CI:7.0%-9.8%).Multivariate Cox regression analysis showed that women aged>35 years had significantly lower risk of PPIUD expulsion than those aged<25 years(HR=0.16,95%CI:0.04-0.64).The risk of GyneFix PPIUD was not statistically significantly associated with cesarean section history and breastfeeding mode(all P>0.05).Nevertheless,this risk was statistically significant between hospitals.The Pearl index of contraceptive failure of the device was 2.37(95%CI:1.09-4.50)per 100 person-years.The rate of contraceptive failure was not associated with maternal age,breastfeeding mode,and history of cesarean delivery(all P>0.05).Conclusion The one-year cumulative expulsion rate of GyneFix PPIUD placed immediately after cesarean section is 8.4%.Young mothers were at a higher risk of expulsion than their older counterparts.The device users should be counseled regarding the signs of expulsion.In case of expulsion,women should be offered reinsertion or other contraceptive methods.The training of service skills of GyneFix PPIUD

关 键 词：剖宫产术 固定式产后放置宫内节育器 脱落 避孕失败 

分 类 号：R719.8[医药卫生—妇产科学]