Maija Haukkamaa

Open randomised study of use of levonorgestrel releasing intrauterine system as alternative to hysterectomy.

OBJECTIVESnTo assess whether the levonorgestrel intrauterine system could provide a conservative alternative to hysterectomy in the treatment of excessive uterine bleeding.nnnDESIGNnOpen randomised multicentre study with two parallel groups: a levonorgestrel intrauterine system group and a control group.nnnSETTINGnGynaecology departments of three hospitals in Finland.nnnSUBJECTSnFifty six women aged 33-49 years scheduled to undergo hysterectomy for treatment of excessive uterine bleeding.nnnINTERVENTIONSnWomen were randomised either to continue with their current medical treatment or to have a levonorgestrel intrauterine system inserted.nnnMAIN OUTCOME MEASUREnProportion of women cancelling their decision to undergo hysterectomy.nnnRESULTSnAt 6 months, 64.3% (95% confidence interval 44.1 to 81.4%) of the women in the levonorgestrel intrauterine system group and 14.3% (4.0 to 32.7%) in the control group had cancelled their decision to undergo hysterectomy (P < 0.001).nnnCONCLUSIONSnThe use of the levonorgestrel intrauterine system is a good conservative alternative to hysterectomy in the treatment of menorrhagia and should be considered before hysterectomy or other invasive treatments.

Endometrial morphology during long-term use of levonorgestrel-releasing intrauterine devices.

Summary Levonorgestrel-releasing intrauterine devices (IUD) were inserted in 92 women. Endometrial biopsies were taken between 3 months and 7 years after these insertions. Intrauterine release of Levonorgestrel resulted in endo-metrial glandular atrophy and decidualized stroma. Inflammation and necrosis were also seen as local signs of IUD use. The biopies were similar regardless of the duration of IUD use. Endometrial morphology returned to normal in biopsy specimens taken 1–3 months after IUD removal.

Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study

The use-effectiveness of an intrauterine contraceptive device releasing 20 mcg of levonorgestrel daily (Lng-IUD), and of a Nova T copper-releasing IUD, were studied in a randomized, comparative multicenter trial. The Lng-IUD was inserted in 1821, and the Nova T in 937 women. The 12-month net pregnancy rate with the Lng-IUD (0.1 per hundred women) was significantly lower than that with the Nova T (0.9 per hundred). Removal rates for menstrual problems and/or pain were similar for the two methods (net rates 7.5 and 8.7, respectively). The 12-month continuation rates were 82.2 for the Nova T and 79.7 for the Lng-IUD. The reduction of the bleeding led to oligomenorrhea and amenorrhea in users of the Lng-IUD; the removal rate for these reasons was 1.4. The removal rate for hormonal side effects with the Lng-IUD was 2.4. Blood hemoglobin concentrations increased among users of the Lng-IUD and decreased among users of the Nova T. The results show that the Lng-IUD was a highly effective contraceptive method which reduced menstrual bleeding. It is a promising alternative for women desiring a highly effective method for long-term use.

A prospective study on buprenorphine use during pregnancy: effects on maternal and neonatal outcome.

Background. Exposure to illicit drugs in utero is associated with low birth weight and premature birth. Therefore, maintenance therapy for opioid dependence during pregnancy has been recommended to help withdrawal from street drugs, in order to improve maternal health and decrease risks to the fetus. Methods. In 2002–2005, 67 pregnancies of 66 buprenorphine users were followed prospectively in an outpatient multidisciplinary antenatal setting by an obstetrician, a midwife, a psychiatric nurse and a social worker. Decreasing doses or even abstinence from buprenorphine was encouraged. Outcome measures were daily buprenorphine dose, fetal growth, gestational age at birth, mode of delivery, birth weight, Apgar scores, umbilical pH values, and occurrence of neonatal abstinence syndrome [NAS]. National statistics were used as reference values. Results. The daily dose of buprenorphine decreased by 2.3 mg (median, range increase of 8 mg to decrease of 24 mg). There were no more incidences of premature birth, cesarean section, low Apgar scores (≤6) or umbilical artery pH <7.05 at birth than in the national register, despite the lower birth weight. A total of 91% of the infants needed treatment in a neonatal care unit, 76% had NAS, and 57% needed morphine replacement therapy. Seven infants were taken into care directly from the maternity hospital. Two sudden infant deaths occurred later. Conclusions. The pregnancies and deliveries of buprenorphine‐using women were uneventful, but severe NAS and need for morphine replacement therapy was seen in 57% of the buprenorphine‐exposed newborns. A high number of sudden infant deaths occurred.

Vaginal contraception with gossypol: A clinical study

A clinical study concerning the vaginal contraceptive efficacy of gossypol acetic acid was performed. Fifteen women who had undergone tubal sterilization volunteered for the study. The effect of vaginal gossypol-containing gel on spermatozoa was determined by postcoital tests performed in subjects without and after using gossypol gel. After gossypol application, the number of spermatozoa found in cervical mucus was greatly decreased and, in eleven of the fifteen women, all spermatozoa seen were immobilized. In four cases a few poorly motile spermatozoa were seen but they showed no forward progression. We have previously reported that gossypol has an inhibitory effect on herpes simplex virus type 2 in vitro. This anti-viral property of gossypol makes it particularly attractive as a topical barrier contraceptive. The present study shows that gossypol is also promising as a vaginal contraceptive agent in human in vivo experiments.

The Levonorgestrel-Releasing IUD

The progestin-only contraceptive method, the minipill, has few general side effects, but there are problems with efficacy and bleeding control. These problems have affected the acceptance of the method, and the need for daily motivation leads to high discontinuation.

Pregnancy outcome with intrahepatic cholestasis

Intrahepatic cholestasis of pregnancy (ICP) is associated with intrapartal fetal distress, meconium passage and preterm delivery, and even perinatal deaths have been reported (1). Some authors have recommended delivery around 36–38 weeks to improve fetal prognosis (2). The value of cardiotocography (CTG) in estimating fetal well-being in pregnancies with ICP has been questioned (3). The risk of fetal distress has been shown to correlate with maternal serum bile acid levels in some (4) but not in all studies (5). However, according to recent reports, the prognosis of ICP seems to have improved together with close monitoring by CTG and timed interventions when fetal distress is suspected (6). Our goal was to evaluate the obstetric outcome of pregnancies with cholestasis with expectant management using careful monitoring of the wellbeing of the fetus and repeated measurements of maternal serum bile acid concentration. The study population and methods are presented in the randomized study of S. Riikonen et al. in this number of Acta (see pages 260–64), where two groups treated with oral guar gum and placebo were evaluated against a control group.

Suppression of Ovarian Function With the Transdermally Given Synthetic Progestin ST 1435

OBJECTIVEnTo study transdermal administration of the synthetic progestin ST 1435 and effectiveness of the steroid in suppression of ovarian function.nnnDESIGN, PATIENTSnThe effect of transdermal administration of the synthetic progestin ST 1435 in suppression of ovarian function was studied in a short term (17 to 93 days) study in healthy regularly menstruating women.nnnSETTINGnThe outpatient clinic of the City Maternity Hospital, Helsinki, Finland.nnnINTERVENTIONnNine women used the progestin ST 1435 transdermally during a total of 21 menstrual cycles. Treatment was started on the 5th day of the menstrual cycle and continued for 17 to 93 days. Three different daily doses (0.5, 0.8, and 1.0 mg) were tested. The steroid was applied to the periumbical area once a day in a gel.nnnMAIN OUTCOME MEASURESnSerum concentrations of ST 1435, progesterone, and estradiol (E2) were determined during the luteal phase of control cycles and in a total of 16 treatment cycles. Bleeding records were kept and side effects registered.nnnRESULTSnTransdermal absorption of the progestin ST 1435 resulted in relatively constant serum concentrations in each subject, depending on the dose used. All doses caused changes in ovarian function. With the 0.5-mg/d dose, inhibition of ovulation was observed in three of five treatment periods. The 0.8-mg/d dose was high enough to inhibit ovulation in 7 of 10 cycles analyzed. With the 1.0-mg/d dose, the serum concentrations of the progestin were high, and anovulation was seen. Serum E2 concentrations were variable in all cases; occasional high peak values were seen, typical of progestin treatment. Bleeding control was variable; irregular bleeding was seen, especially in anovulatory cases.nnnCONCLUSIONSnA 0.8-mg dose of the progestin ST 1435 administered transdermally once a day appeared to suppress ovulation, if properly applied, and excessive suppression of ovarian function was not seen. The steroid was well accepted. The synthetic progestin ST 1435 given transdermally represents an effective alternative for inhibition of ovulation and for progestin therapy.