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- W2023856746 abstract "In the above article, the authors detected some errors in Table 2, Table 3 [[1]Meirik O. Rowe P.J. Peregoudov A. Piaggio G. Petzold M. for the IUD Research Group at the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human ReproductionThe frameless copper IUD (GyneFix) and the TCU380A: results of an eight year multicenter randomized comparative trial.Contraception. 2009; 80: 133-141Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar].Table 2All centers, number of women entering each year of follow-up, cumulative number of woman–years and rates (95% confidence limits in parenthesis) of pregnancy, expulsions, IUD removals for pain or bleeding or both, pelvic inflammatory disease, other medical and nonmedical reasons for removal, overall continuationVariable1st year2nd year3rd year4th yearGyneFixTCu380AGyneFixTCu380AGyneFixTCu380AGyneFixTCu380ANo. of womenaNumber of women starting the interval with the IUD in uteri.19842036170718021585163814691492Woman-years18071893344836094968516363526581Pregnancies All1.3 (0.9–2.0)0.5 (0.3–0.9)1.7 (1.2–2.5)1.2 (0.8–1.8)2.1 (1.6–2.9)1.7 (1.2–2.4)2.2 (1.6–3.0)2.0 (1.5–2.8) Intrauterine1.3 (0.9–2.0)0.4 (0.2–0.9)1.7 (1.2–2.4)1.1 (0.7–1.7)2.1 (1.5–2.9)1.6 (1.1–2.3)2.1 (1.6–3.0)1.8 (1.3–2.6) Ectopic00.1 (0.0–0.4)0.1 (0.0–0.4)0.1 (0.0–0.5)0.1 (0.0–0.4)0.1 (0.0–0.5)0.1 (0.0–0.4)0.3 (0.1–0.7)Expulsions All5.3 (4.4–6.4)2.5 (1.9–3.3)6.2 (5.2–7.3)3.3 (2.5–4.2)7.0 (6.0–8.3)4.1 (3.3–5.1)7.5 (6.4–8.8)4.3 (3.5–5.4) Total4.7 (3.9–5.8)0.6 (0.4–1.1)5.5 (4.6–6.6)0.7 (0.4–1.2)6.2 (5.2–7.4)1.2 (0.8–1.8)6.6 (5.6–7.9)1.3 (0.8–1.9) Partial0.6 (0.3–1.1)1.9 (1.4–2.6)0.7 (0.4–1.2)2.5 (1.9–3.4)0.8 (0.5–1.4)3.0 (2.3–3.9)0.9 (0.6–1.5)3.1 (2.4–4.0)Removals All medical removals9.0 (7.9–10)6.5 (5.5–7.7)12 (11–14)10 (9.1–12)15 (14–17)14 (12–15)18 (17–20)16 (14–17) All pain and/or bleeding2.6 (1.9–3.4)3.4 (2.7–4.3)4.3 (3.4–5.3)5.8 (4.8–7.0)6.4 (5.3–7.6)7.5 (6.4–8.9)8.7 (7.4–10)9.1 (7.9–11) Pain0.6 (0.3–1.1)0.8 (0.5–1.3)0.8 (0.5–1.4)1.4 (1.0–2.1)1.2 (0.8–1.9)1.9 (1.3–2.6)1.5 (1.0–2.2)2.3 (1.7–3.1) Bleeding1.6 (1.1–2.3)2.1 (1.5–2.8)3.0 (2.3–3.9)3.6 (2.9–4.6)4.3 (3.5–5.4)4.7 (3.8–5.8)6.1 (5.1–7.4)5.9 (4.9–7.1) Pain and bleeding0.4 (0.2–0.8)0.6 (0.3–1.0)0.5 (0.3–1.0)0.9 (0.5–1.4)0.9 (0.5–1.5)1.1 (0.7–1.7)1.2 (0.8–1.9)1.2 (0.8–1.8) Other medical removals0.1 (0.0–0.5)00.4 (0.2–0.8)0.1 (0.0–0.4)0.6 (0.3–1.2)0.5 (0.2–0.9)1.0 (0.6–1.6)0.7 (0.4–1.2) Nonmedical removals1.5 (1.0–2.2)1.2 (0.8–1.8)3.8 (3.0–4.8)3.8 (3.0–4.8)5.6 (4.6–6.8)6.7 (5.6–8.0)9.1 (7.8–11)9.4 (8.1–11)PID00.3 (0.1–0.6)0.1 (0.0–0.4)0.4 (0.2–0.8)0.1 (0.0–0.5)0.4 (0.2–0.8)0.3 (0.1–0.7)0.4 (0.2–0.8)Overall discontinuation rate11 (9.4–12)7.8 (6.7–9.1)16 (14–17)14 (13–16)21 (19–22)20 (18–22)26 (24–28)24 (22–26)Lost to follow-up3.7 (2.9–4.6)4.0 (3.2–4.9)5.2 (4.3–6.3)6.5 (5.4–7.7)6.9 (5.8–8.2)8.8 (7.6–10)]9.1 (7.8–11)11 (9.5–12)End of studybNumber of women discontinued for reason of “end of study”; see section on Materials and Methods.00000000Variable5th year6th year7th year8th yearNo. of womenaNumber of women starting the interval with the IUD in uteri.13331380119912379131135521948Woman-years7628789286849071932610,101969610,889Pregnancies All2.4 (1.7–3.2)2.7 (2.0–3.6)2.4 (1.7–3.2)2.9 (2.1–3.8)2.5 (1.8–3.4)3.0 (2.2–4.0)2.5 (1.8–3.4)3.0 (2.2–4.0) Intrauterine2.3 (1.7–3.1)2.2 (1.6–3.1)2.3 (1.7–3.1)2.4 (1.8–3.3)2.4 (1.8–3.3)2.5 (1.8–3.4)2.4 (1.8–3.3)2.5 (1.8–3.4) Ectopic0.1 (0.0–0.4)0.5 (0.2–1.0)0.1 (0.0–0.4)0.5 (0.2–1.0)0.1 (0.0–0.4)0.5 (0.2–1.0)0.1 (0.0–0.4)0.5 (0.2–1.0)Expulsions All7.7 (6.6–9.0)4.5 (3.7–5.6)8.1 (7.0–9.5)4.7 (3.8–5.8)8.8 (7.5–10)5.1 (4.2–6.3)9.0 (7.7–11)6.1 (5.0–7.5) Total6.9 (5.8–8.1)1.3 (0.9–2.0)7.2 (6.1–8.5)1.5 (1.0–2.2)7.9 (6.7–9.4)1.7 (1.1–2.4)8.1 (6.8–9.7)1.8 (1.2–2.6) Partial0.9 (0.6–1.5)3.3 (2.5–4.2)1.0 (0.6–1.6)3.3 (2.5–4.2)1.0 (0.6–1.6)3.5 (2.8–4.5)1.0 (0.6–1.6)4.4 (3.4–5.6)Removals All medical removals20 (19–22)18 (16–20)23 (21–25)20 (18–22)26 (24–29)23 (21–25)29 (27–32)27 (25–30) Pain and/or bleeding10 (8.8–12)10 (9.1–12)12 (11–14)12 (10–13)15 (13–17)15 (13–16)18 (15–20)18 (16–20) Pain1.8 (1.3–2.6)2.7 (2.0–3.6)2.1 (1.5–3.0)3.1 (2.3–4.1)2.4 (1.7–3.4)3.9 (3.0–5.1)2.4 (1.7–3.4)4.6 (3.6–5.9) Bleeding7.3 (6.1–8.7)6.8 (5.7–8.1)9.0 (7.7–11)7.7 (6.5–9.1)12 (9.8–14)9.7 (8.3–11)14 (12–16)12 (10–14) Pain and bleeding1.4 (0.9–2.1)1.3 (0.9–2.0)1.6 (1.0–2.3)1.4 (1.0–2.1)1.7 (1.1–2.6)1.6 (1.1–2.4)2.3 (1.4–3.7)1.9 (1.3–2.7) Other medical removals1.1 (0.7–1.8)0.9 (0.5–1.5)1.7 (1.1–2.6)1.4 (0.9–2.1)2.2 (1.5–3.3)1.7 (1.2–2.6)2.5 (1.6–3.7)2.5 (1.7–3.6) Nonmedical removals12 (11–14)15 (13–17)16 (14–18)18 (16–20)19 (17–21)20 (18–22)20 (18–22)22 (20–25)PID0.3 (0.1–0.7)0.5 (0.2–0.9)0.4 (0.2–0.9)0.5 (0.2–0.9)0.4 (0.2–0.9)0.6 (0.3–1.1)0.4 (0.2–0.9)0.7 (0.4–1.3)Overall discontinuation rate30 (28–33)30 (28–33)35 (33–38)34 (32–36)41 (38–43)39 (37–41)44 (41–47)44 (42–46)Lost to follow-up11 (9.2–12)13 (11–14)12 (11–14)15 (14–17)21 (19–24)24 (22–26)32 (29–36)39 (36–41)End of studybNumber of women discontinued for reason of “end of study”; see section on Materials and Methods.2.9 (2.1–4.0)019 (17–21)044 (41–47)063 (59–66)0a Number of women starting the interval with the IUD in uteri.b Number of women discontinued for reason of “end of study”; see section on Materials and Methods. Open table in a new tab Table 3Non-Chinese centers, number of women entering each year of follow-up, cumulative number of woman-years and rates (95% confidence limits in parenthesis) of pregnancy, expulsions, IUD removals for pain or bleeding or both, pelvic inflammatory disease, other medical and nonmedical reasons for removal, overall continuationVariable1st year2nd year5th year8th yearGyneFixTCu380AGyneFixTCu380AGyneFixTCu380AGyneFixTCu380ANo. of womenaNumber of women starting the interval with the IUD in uteri.79483659667536441491206Woman-years670733122213542423267128203350Pregnancies All2.4 (1.5–3.8)0.4 (0.1–1.3)2.7 (1.7–4.3)1.1 (0.5–2.2)3.3 (2.2–5.1)2.0 (1.1–3.7)3.3 (2.2–5.1)2.0 (1.1–3.7) Intrauterine2.4 (1.5–3.8)0.4 (0.1–1.3)2.7 (1.7–4.3)1.1 (0.5–2.2)3.3 (2.2–5.1)1.8 (0.9–3.3)3.3 (2.2–5.1)1.8 (0.9–3.3) Ectopic000000.3 (0.0–1.8)00.3 (0.0–1.8)Expulsions All7.7 (6.0–9.9)3.1 (2.1–4.6)9.4 (7.4–12)3.8 (2.6–5.4)12 (9.6–15)5.3 (3.8–7.3)16 (12–21)5.8 (4.1–8.1) Total6.7 (5.1–8.7)0.4 (0.1–1.2)8.0 (6.2–10)0.7 (0.3–1.7)10 (8.2–13)1.3 (0.6–2.6)15 (11–20)1.3 (0.6–2.6) Partial1.1 (0.6–2.2)2.8 (1.8–4.2)1.5 (0.8–2.7)3.1 (2.1–4.6)1.7 (0.9–3.0)4.0 (2.7–5.9)1.7 (0.9–3.0)4.5 (3.0–6.8)Removals All medical removals14 (12–17)8.0 (6.3–10)18 (15–21)13 (11–15)29 (26–33)22 (19–25)42 (36–47)36 (32–41) All pain and/or bleeding4.3 (3.0–6.1)4.1 (2.9–5.8)6.3 (4.7–8.5)7.5 (5.8–9.7)15 (12–18)13 (11–16)25 (20–31)28 (24–33) Pain1.4 (0.8–2.7)1.1 (0.6–2.2)2.1 (1.3–3.6)2.9 (1.9–4.5)5.0 (3.4–7.4)6.0 (4.2–8.3)6.6 (4.4–9.9)11 (8.5–15) Bleeding2.3 (1.4–3.8)2.3 (1.4–3.6)3.6 (2.4–5.3)3.7 (2.5–5.4)8.7 (6.5–12)6.2 (4.4–8.5)16 (12–21)16 (12–20) Pain and bleeding0.6 (0.2–1.6)0.8 (0.4–1.8)0.8 (0.3–1.8)1.1 (0.6–2.2)1.9 (1.0–3.6)1.8 (1.0–3.4)4.4 (1.9–10)3.4 (1.8–6.2) Other medical removals0.3 (0.1–1.3)00.5 (0.2–1.5)0.2 (0.0–1.2)1.4 (0.7–3.0)1.9 (1.0–3.6)2.8 (1.4–5.5)2.9 (1.6–5.1) Nonmedical removals3.5 (2.4–5.3)2.6 (1.7–4.1)8.1 (6.2–11)8.4 (6.5–11)32 (28–36)38 (34–42)54 (48–60)56 (52–60)PID00.5 (0.2–1.4)0.2 (0.0–1.2)0.8 (0.4–1.8)0.6 (0.2–2.0)1.1 (0.5–2.3)1.1 (0.4–3.1)1.6 (0.7–3.7)Overall discontinuation rate18 (15–21)11 (8.9–13)25 (22–29)21 (18–24)52 (49–56)52 (48–56)74 (69–78)73 (69–76)Lost to follow-up8.9 (7.1–11)9.4 (7.6–12)12 (10–15)14 (12–17)20 (17–24)23 (20–27)29 (24–35)31 (27–35)End of studybNumber of women discontinued for reason of “end of study”; see section on Materials and Methods.000011 (8.4–15)055 (49–62)0a Number of women starting the interval with the IUD in uteri.b Number of women discontinued for reason of “end of study”; see section on Materials and Methods. Open table in a new tab In Table 2, the 7th and 8th year rates with 95% confidence limits of “Other medical removals” for the frameless IUD should read 2.2 (1.5–3.3) and 2.5 (1.6–3.7), respectively, and for the TCu380A it should be 1.7 (1.2–2.6) and 2.5 (1.7–3.6), respectively, as shown in the corrected Table 2. Also in Table 2, the overall discontinuation rate of the frameless device for the 7th year should read 41 (38–43). In Table 3, the number of women using TCu380A starting the 8th year should read 206, and the number of women using the frameless IUD stopping participation in the study in the 8th year for the reason “end of study” should be 55 (49–62) (Table 3). In addition, some rounding errors in the rates and confidence limits in the two tables have been corrected. The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trialContraceptionVol. 80Issue 2PreviewClinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared. Full-Text PDF" @default.
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