RESUMEN
Since promising results were obtained with the CuFix interval implant system in international clinical trials conducted worldwide, a modification of the device adapting it for immediate postplacental insertion and fixation (IPPIF) seemed a logical approach to solve the expulsion problem of IUDs inserted at that particular time. Seventy-three insertions were performed at three university centers, during 1990 and 1991, both by skilled and unskilled investigators. The results of this multicenter study show the excellent retainability of the modified IUD supporting the validity of the anchoring principle. The insertion procedure is easy, requiring minimal training, and the insertion technique appeared to be safe.
PIP: Physicians inserted the CuFix postpartum (CuFixPP) implant system, an IUD, to a depth of 1.3 cm in the fundal myometrium in 73 healthy women soon after vaginal delivery (10-30 minutes) at either the University Hospital in Gent, Belgium; the University Medical School in Debrecen, Hungary; or Alexandra Hospital of the University of Athens in Greece. Since previous international clinical trials showed unacceptably high rates of expulsion of CuFixPP, researchers conducted this trial to test the IUD after having it modified for immediate postplacental insertion and fixation. None of the physicians had received training in the insertion procedure of this experimental IUD. The cumulative expulsion rate at 12 and 18 months was 3.1. The cumulative pregnancy rate at 12 and 18 months stood at 1.5. The sole reasons for removal at 12 and 18 months were bleeding/pain and planned pregnancy (7.4 at 12 and months and 10.8 at 18 months; 9 at 12 months and 12.2 at 18 months, respectively). Physicians experienced difficulty removing the IUD in 4 cases. The removals did not cause noticeable bleeding. No complications occurred. These findings revealed that, with further modifications, the CuFixPP IUD holds considerable promise as a simple and effective method of postpartum contraception, which can easily be inserted by nurses or midwives, especially in developing countries.