Table 3

Comparison of thrombosis outcome in women with factor V Leiden or prothrombin G20210A, or a combination of these defects (including homozygosity)

Defects
No defects
COCLNG-IUDCopper IUD (380 mm2)Condom*COCLNG-IUDCopper IUD (380 mm2)Condom*
Incidence of first VTE per 100 pregnancy-years 0.55 0.25 0.25 0.25 0.19 0.09 0.09 0.09 
Cases of VTE per 100 000 pregnancy-years 550 250 250 250 190 90 90 90 
Contraceptive failure rate, per 100 women-years§ 0.2 0.7 1.4 12 0.2 0.7 1.4 12 
Unintended pregnancies per 100 000 pregnancy-years 200 700 1400 12 000 200 700 1400 12 000 
Incidence of VTE per 100 pregnancy-years 2.8 2.8 2.8 2.8 0.7 0.7 0.7 0.7 
Additional cases of VTE 20 40 336 10 84 
Total number of VTE 556 270 290 586 192 95 100 174 
Defects
No defects
COCLNG-IUDCopper IUD (380 mm2)Condom*COCLNG-IUDCopper IUD (380 mm2)Condom*
Incidence of first VTE per 100 pregnancy-years 0.55 0.25 0.25 0.25 0.19 0.09 0.09 0.09 
Cases of VTE per 100 000 pregnancy-years 550 250 250 250 190 90 90 90 
Contraceptive failure rate, per 100 women-years§ 0.2 0.7 1.4 12 0.2 0.7 1.4 12 
Unintended pregnancies per 100 000 pregnancy-years 200 700 1400 12 000 200 700 1400 12 000 
Incidence of VTE per 100 pregnancy-years 2.8 2.8 2.8 2.8 0.7 0.7 0.7 0.7 
Additional cases of VTE 20 40 336 10 84 
Total number of VTE 556 270 290 586 192 95 100 174 

According to the method described by Koster et al.39 

LNG-IUD indicates levonorgestrel intrauterine device; HR, hazard ratio; and VTE, venous thromboembolism.

*

US data.

(6 + 2) events during (1218 + 232) pill-years (see Table 2).

Based on an adjusted HR of 2.2 for COC use when compared to no COC use.

§

Pearl Index for correct use (method failure).

(10 + 7) events during (507 + 92) pregnancy-years (see Table 2).

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