Che Yan, Hou Gui-Fang, Zhang Hong-Ping, Yang Heng, Lin Shu-Juan, Gan Tao, Yang Wei-Hua, Shi Chun-Hui, Ren Wei-Juan, Xu Ying-Qin, Yin Bao-Ming, Chen Ting-Ting, Gan Yu-Jie, Zhang Yuan, Zhang Yan, Cheng Li-Nan
NHC Key Lab of Reproduction Regulation, Shanghai Institute for Biomedical and Pharmaceutical Technologies, Shanghai, China; Departiment of Family Planning, Weifang People's Hospital, Shandong, China.
Department of Obstetrics, The Second People's Hospital of Huadu District, Guangzhou, China.
Contraception. 2023 Jun;122:109999. doi: 10.1016/j.contraception.2023.109999. Epub 2023 Feb 26.
To assess the effectiveness, safety, and acceptability of postplacental insertion of GyneFix postpartum intrauterine device (PPIUD) in women undergoing cesarean section (C-section).
We conducted a prospective cohort study at 14 hospitals in four eastern coastal provinces of China between September 2017 and November 2020. A total of 470 women who underwent C-section and consented to the postplacental insertion of GyneFix PPIUD were enrolled, and 400 completed the 12-month follow-up. Participants were interviewed in the wards after delivery and followed up at 42 days, and months 3, 6, and 12 after delivery. We used Pearl Index (PI) to measure the rate of contraceptive failure, life-table method to measure the rate of PPIUD discontinuation, including IUD expulsion, and Cox regression model to explore the risk factors associated with discontinuation of the device.
Nine pregnancies were detected during the first year after GyneFix PPIUD insertion: seven were due to device expulsion and two occurred with PPIUD in situ. The PIs for overall 1-year pregnancy rate and pregnancies with IUD in situ were 2.3 (95% CI: 1.1-4.4) and 0.5 (95% CI: 0.1-1.9), respectively. The 6- and 12-month cumulative expulsion rates for PPIUD expulsion were 6.3% and 7.6%, respectively. The overall 1-year continuation rate was 86.6% (95% CI: 83.3-89.8). We did not identify any patient with insertion failure, uterine perforation, pelvic infection, or excess bleeding due to GyneFix PPIUD insertion. Women's age, education, occupation, previous history of C-section, parity, and breastfeeding were not associated with removal of GyneFix PPIUD in the first year of use.
Postplacental insertion of GyneFix PPIUD is effective, safe, and acceptable for women undergoing C-section. Expulsion is the most common reason for GyneFix PPIUD discontinuation and pregnancy. The expulsion rate for GyneFix PPIUD is lower than that for framed IUDs, but more evidence is needed for a firm verdict.
评估剖宫产术后放置吉妮柔适宫内节育器（GyneFix产后宫内节育器，PPIUD）的有效性、安全性和可接受性。
2017年9月至2020年11月期间，我们在中国东部沿海四省的14家医院开展了一项前瞻性队列研究。共纳入470例行剖宫产且同意在胎盘娩出后放置GyneFix PPIUD的女性，400例完成了12个月的随访。参与者在产后于病房接受访谈，并在产后42天、3个月、6个月和12个月进行随访。我们使用Pearl指数（PI）来衡量避孕失败率，用寿命表法来衡量PPIUD取出率，包括宫内节育器脱落，并使用Cox回归模型来探讨与该装置取出相关的危险因素。
在放置GyneFix PPIUD后的第一年共检测到9例妊娠：7例因节育器脱落，2例发生时节育器在位。1年总妊娠率及节育器在位时的妊娠率的Pearl指数分别为2.3（95%CI：1.1 - 4.4）和0.5（95%CI：0.1 - 1.9）。PPIUD脱落的6个月和12个月累积脱落率分别为6.3%和7.6%。1年总续用率为86.6%（95%CI：83.3 - 89.8）。我们未发现因放置GyneFix PPIUD出现置入失败、子宫穿孔、盆腔感染或出血过多的患者。女性的年龄、教育程度、职业、既往剖宫产史、产次和母乳喂养情况与使用第一年GyneFix PPIUD的取出无关。
剖宫产术后放置GyneFix PPIUD对剖宫产女性有效、安全且可接受。脱落是GyneFix PPIUD停用和妊娠的最常见原因。GyneFix PPIUD的脱落率低于有框架宫内节育器，但需要更多证据才能得出确切结论。
