Biomedical subjects
Päivi Pakarinen
Publications and source records attributed to Päivi Pakarinen.
Five years' experience with a small intracervical/intrauterine levonorgestrel-releasing device.
OBJECTIVE: A randomized study was performed to compare the efficacy, safety and acceptability of a new model of an intracervical/intrauterine contraceptive device (ICD) releasing 20 microg of levonorgestrel (LNG) per day. METHODS: The LNG-ICD was inserted in Group I into the cervical canal and in Group II into the uterine cavity. Group I included 151 women (age, 18-43 years) whereas Group II included 147 (age, 19-43 years). The number of nulliparous women was 145. RESULTS: The 5-year results are presented here. The results showed a total continuation rate of 50%; the continuation rate in the cervical group and that in the uterine group were 53.6% and 46.3%, respectively--the difference being statistically insignificant (p=.3593). The main reason for termination was a wish for pregnancy, which is explained by the relatively young age and degree of nulliparity of the study population. During the first year, two pregnancies occurred in both groups. Two of these were ectopic, one in each group. The other two occurred after unnoticed expulsions. Thereafter, no pregnancies occurred. The cumulative gross rate for pregnancy was 1.3 and the Pearl index at 5 years was 0.425. The total expulsion rate was relatively high (11.1%). Expulsions occurring during the first few months of the first year were related to insertion. Removals because of bleeding and because of amenorrhea were low, the combined gross rate being 5.7 and the Pearl rate 1.8 at 5 years. Also, the gross rate of infection was low (0.7). The continuation was high in spite of a high rate of removals for planning pregnancy (15.4). CONCLUSIONS: The method is safe and effective. There were only minor differences between the groups. There were no perforations and the incidence of infection was low. The device can also be used by young nulliparous women.
[Strong nausea during pregnancy].
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Randomized comparison of levonorgestrel- and copper-releasing intrauterine systems immediately after abortion, with 5 years' follow-up.
Women who seek an abortion are motivated to use contraceptive methods afterwards. Because the return of fertility after abortion is immediate, there is a need for effective and safe contraception promptly after the termination of pregnancy. A randomized trial of Mirena and NovaT intrauterine contraceptive devices inserted at the time of elective termination of pregnancy, duration no more than 12 weeks, is reported here. Women were randomized 2:1 resulting in 305 subjects with Mirena and 133 with NovaT as a segment of a larger study of 3000 women. In the Mirena group, two pregnancies at year 4 resulted in a final gross rate of 0.8 at 5 years, which was significantly (p < 0.0004) lower than the corresponding rate of 9.5 with NovaT. Terminations because of expulsion, bleeding problems, pain, pelvic inflammatory disease and other medical reasons were less common in the Mirena group, but not significantly different. The cumulative expulsion gross rate for NovaT at 5 years was 15.4 and for Mirena it was 10.5. Termination rates because of amenorrhea were low in both groups. It is concluded that both devices were well tolerated. Mirena was more effective and the rate of adverse events was lower than with NovaT. Special attention should be paid to the insertion procedure when carried out at the time of abortion.