Expulsion rate and influencing factors of GyneFix postpartum intrauterine device placed immediately after cesarean section:a prospective cohort study Trial Registration:Chinese Clinical Trial Registry,ChiCTR1900023828
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 should be strengthened in order to mitigate the risk of the device expulsion.
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