The wording of the informed consent in gynecology.

In many western States medical activity is characterized by legal difficulties regarding the patients' consent. In this paper we have confronted the medical and legal problems connected to the wording of the informed consent in diagnostic and therapeutic practice in gynecology and obstetrics. In this area the role of Scientific Societies seems ever more important in that they could carry-out an important task by having the possibility of acquiring and coordinating the maximum amount of knowledge in both the specialistic medical field and the judiciary field. Here, we discuss the various aspects of the preparation of appropriate forms for correct patient information and the valid acquisition of the patient's consent for medical records.

Beta-interferon treatment of cervical intraepithelial neoplasia: a multicenter clinical trial.

Forty-nine women with cervical intraepithelial neoplasia (CIN) grade II were treated with systemic and/or local beta-interferon (beta-IFN) applications. The aim of the study was to compare the efficacy of different routes for the administration of beta-IFN, evaluate local and systemic beta-IFN tolerance, and determine whether disappearance of neoplastic lesions was related to the resolution of the concomitant human papillomavirus infection. The patients were randomized to receive intramuscular, intralesional or a combination of intramuscular and intralesional administration, or conventional treatment. Significant differences in the rate of lesion regression were observed between treated and untreated women. The highest frequency of complete response was observed with the therapy combining intramuscular and intralesional treatment.

Correlation of Doppler and placental immunohistochemical features in normal and intrauterine growth-retarded fetuses.

The aim of this study was to correlate and compare Doppler and anatomical placental findings obtained from 48 normal and 35 intrauterine growth-retarded (IUGR) fetuses. The IUGR group consisted of 19 fetuses from pregnancies complicated by pre-eclampsia and 16 from healthy mothers. Color Doppler evaluation of umbilical, spiral and uterine arteries was performed. Placental specimens from both normal and growth-retarded fetuses were obtained at the time of delivery. Placental specimens were evaluated using histochemical and immunohistochemical techniques. A progressive decrease in the pulsatility index was observed in umbilical, spiral and uterine arteries throughout pregnancy in the normal-growth fetuses. High umbilical artery pulsatility index values were obtained in 29 out of the 35 growth-retarded fetuses, six of them showing absent or reversed end-diastolic umbilical artery flow pattern. A total of 13 IUGR fetuses showed high resistance uterine artery flow velocity waveforms. Increased pulsatility index values were obtained from the spiral arteries of 16 growth-retarded fetuses. Abnormal histological and histochemical placental patterns were observed in all the growth-retarded fetuses with umbilical artery Doppler abnormalities. The presence of a peculiar dendritic cell subpopulation, strongly resembling the Langerhans cells, expressing the HLA-DR+/CD1+ phenotype, was detected in all growth-retarded fetuses, whether there was maternal pathology or not. Our data show uterine and spiral artery data as being ineffective in the monitoring of IUGR fetuses. The placental extracellular matrix seems to play an important role in the regulation of the umbilical circulation. The presence of CD1+ cells as a sign of a possible immunological mechanism in the pathogenesis of the intrauterine growth retardation is discussed.

Treatment of postmenopausal osteoporosis with salmon calcitonin nasal spray: evaluation by bone mineral content and biochemical patterns.

We studied 21 women with postmenopausal osteoporosis, treated with salmon calcitonin nasal spray (100 IU/daily) and calcium (1 g/daily) for six months. Bone mineral content (BMC), measured before and at the end of therapy with lumbar dual photon absorptiometry, showed a significant increase (p < 0.01). At the end of the study, there was also a clear improvement of osteoporotic pain. Among biochemical markers of bone turnover, there was a significant (p < 0.01) reduction of urinary excretion of hydroxyproline. No side effect was registered and all patients had a good compliance to therapy.

Uterine fibroids: protocols of integrated medical/surgical treatment.

Uterine fibroids are the most common solid pelvic tumor in women and in these last years their management has been deeply reviewed. An optimal integration of GnRH analogue treatment with different surgical techniques require an adequate work-up for the specific problems of each single patient. For a correct management of these patients, we divided them into 4 categories on the basis of symptoms and specific objectives to persuasive: a) perimenopausal patients; b) young patients, symptomatic or with large myomas, with no wish for more children; c) young patients, symptomatic or with large myomas, wishing to preserve fertility; d) infertile patients or patients with history of repeated miscarriages. Our suggested work-up is the following: a careful USGraphic evaluation of fibroid size and localization, a transvaginal doppler examination of the uterine blood supply, a complete haematochemical analysis, a hysteroscopy guided biopsy and a complete bone evaluation. On the basis of the above mentioned evaluations for each group we will use a different therapeutic approach in regard of either length of medical treatment (for tree to six months, for one or more cycles) or necessity of surgical treatment (with the possibility to get a natural menopausal), or different surgical techniques (operative hysteroscopy and/or laparoscopy, laparotomic myomectomy, vaginal or abdominal hysterectomy.

Double-blind controlled trial of progesterone vaginal cream treatment for cyclical mastodynia in women with benign breast disease.

The clinical effectiveness and safety of vaginal micronized progesterone treatment in mastodynia were evaluated in a double-blind placebo controlled study. Eighty regularly menstruating women affected by severe cyclical mastodynia were randomly assigned to two groups of 40 patients. One group was treated for 6 cycles from the 19th to the 25th day of the cycle with 4 g of vaginal cream containing 2.5% natural progesterone. The other group was similarly treated with placebo. The treatment was preceded by a control cycle. All patients reported every day their breast pain on a 100 mm visual linear analogue scale (VAS). The response of breast tenderness and nodularity to treatment was assessed by clinical examination. Vaginal progesterone resulted significantly more efficacious than placebo in reducing mean ratings of breast pain on VAS and mean scores of breast tenderness to touch. Success of treatment, defined as reduction greater than 50% of basal mean score of breast pain on VAS, was achieved in the 64.9% of patients treated with progesterone and in the 22.2% of patients receiving placebo (p < 0.01). Conversely, at the end of treatment, the improvement in breast nodularity showed a not statistically significant difference between the two groups. No major side-effects were detected.

Malpractice in obstetrics: a contribution of cases in southern Italy.

Looking ahead to the abolition of many intra-European frontiers the Authors offer this contribution to the discussion of the medico-legal aspects of gynecological activity in the United Europe of 1993. It is to this end that they present the data from a review of the material which has been the subject of litigation on the part specialists in Southern Italy, also commenting on the case series in the light of the Italian provisions in force up to date.

Leuprorelin acetate depot vs danazol in the treatment of endometriosis: results of an open multicentre trial.

A national multicentre trial was organized in order to compare the efficacy and safety of leuprorelin acetate depot and danazol in the treatment of endometriosis. Sixty-seven patients with pelvic endometriosis of different severity at laparoscopy were included in the study and followed during the 24 weeks of treatment. Leuprorelin acetate depot 3.75 mg was injected every 24 days, while the daily dose of danazol was 600-800 mg. At the end of the study objective improvements induced by the two drugs were observed by a second laparoscopic examination. In addition, at regular intervals during the study semiquantitative evaluation of subjective symptoms were monitored. Scoring the final objective changes in the two patient groups revealed no significant difference, however the women treated with leuprorelin acetate depot registered significantly better control of pelvic pain. Due to its efficacy, tolerability and ease of use, leuprorelin acetate appears to be an excellent drug for the treatment of endometriosis.

Fetal cerebral haemodynamic adaptation: a progressive mechanism? Pulsed and color Doppler evaluation.

The importance of studying, by Doppler ultrasound, the cerebral haemodynamics to monitor the fetal response to the hypoxia is well known, but there is not a general agreement about the anatomical landmarks for the middle cerebral artery. Seventy-one normal fetuses and fifteen IUGR fetuses were studied. The umbilical artery and the middle cerebral artery (MCA) were evaluated by color Doppler ultrasound. The well-known decrease of the pulsatility index from the umbilical artery was observed throughout pregnancy. This velocimetric pattern did not occur in the IUGR fetuses. Four IUGR fetuses showed the ARED (absent or reversed and diastolic flow) pattern. The MCA was evaluated at the origin (M1) and at the distal tract (M2). PI values from M1 and M2 decreased during the pregnancy. A significant difference was detected between M1 and M2 PI values from the 26th to the 37th week of gestation. The M1 brain sparing effect was detected in the IUGR fetuses. Two ARED fetuses, observed during labor, showed the M2 sparing effect. The different Doppler patterns found in M1 and M2 could be due to the functional differences existing between these tracts. As a matter of fact, M1 and M2 supply different parts of the fetal brain, which develop in different periods of fetal life. These findings, if ulteriorly confirmed, could offer new perspectives for the monitoring of high risk fetuses.

Objective and subjective data for fertile period diagnosis in women: comparison of methods.

The Authors have evaluated the reliability of various methods, both natural and biochemical, for the identification of the female ovulatory period in women with regular periods. They compared these methods among themselves and with echographical checking of ovulation. It emerged clearly from the study that the greatest reliability among the natural methods is obtained through the evaluation of the presence of cervical mucus, while among biochemical methods the best results are obtained by a semiquantitative colorimetric test. Brilliant prospects have also been opened by research on saliva.

The effect of various drugs with neuroendocrine activity and transdermal estradiol on plasma gonadotropin concentrations after ovariectomy in reproductive-aged women.

In the present study we compared the effect of different neuroactive drugs with that of estrogen treatment on the ovariectomy-induced plasma luteinizing hormone (LH) and follicle-stimulating hormone (FSH) changes. A total of 35 menstruating women undergoing ovariectomy were randomly divided into five groups of 7 patients each, receiving a 4-week treatment with oral clonidine, lisuride and sodium valproate, transdermal 17 beta-estradiol, or placebo. The treatment started the day after ovariectomy. Surgery was done during the early follicular phase of the cycle. Blood samples were collected before and after 3, 5, 7, 14, 21 and 28 days of treatment. During the treatment, hot flushes were subjectively recorded. The placebo-treated group showed a progressive increase in plasma LH and FSH concentration during the month following ovariectomy. The same changes occurred in the lisuride and sodium valproate treated groups. Plasma LH levels in ovariectomized women treated with clonidine showed an increase which was higher than in placebo-treated women (p less than 0.01), while FSH levels were similar to those in the placebo group. In the estradiol-treated group the increase in both gonadotropins was significantly less (p less than 0.01) than in the placebo group. The frequency and intensity of hot flushes were high in placebo and sodium valproate treated subjects, being significantly reduced by clonidine, lisuride and estrogen treatment. Our results seem to indicate that clonidine treatment modulates the LH postcastration rise and that both neuroendocrine and gonadal mechanisms influence the changes in the activity of the GnRH-pituitary axis following ovariectomy.

[Carcinoembryonic antigen in genital infections caused by HPV]. / Antigène carcino-embryonnaire dans les infections génitales à HPV.

The immunohistochemical search for the carcino-embryonic antigen (CEA) was positive in 28.14 per cent of the cases of plane cervical condylomata, in 25 per cent of the cases of infections of the vulva by HPV, and in up to 40 per cent of the cases of cervical or vulvar lesions. These data are in accordance with those reported in the literature, even if the number of cases studied is too limited to enable us to make a significant comparison. As a result, the CEA might prove to be a useful marker for a more accurate biological and chemical classification of genital lesions by HPV.

[Topical treatment with estriol in postmenopausal atrophic vaginitis]. / Traitement topique avec estriole de la vaginite atrophique post-ménopause.

The vaginal application of estriol leads to plasma free estriol levels validated on the basis of laboratory and clinical parameters at a dose very much less than that.

Relationship between cerebrospinal fluid beta-endorphin and plasma pituitary-gonadal hormone levels in women.

Brain beta-endorphin (beta-EP) plays an important role in regulating the hypothalamus-pituitary-gonadal axis activity. Cerebrospinal fluid (CSF) beta-EP levels seem to reflect the central rather than pituitary secretion. With the aim to correlate the changes of plasma estradiol (E2), progesterone, luteinizing hormone (LH) and follicle-stimulating hormone with brain beta-EP, CSF levels of beta-EP were measured in 15 normally cycling and 15 postmenopausal women. CSF beta-EP levels in post-menopausal women were lower than in fertile women. A positive correlation between plasma E2 and CSF beta-EP level was found in all women. In fertile women CSF beta-EP levels were inversely correlated to plasma gonadotropin levels. These results showed that CSF beta-EP levels differ between fertile and postmenopausal women and are correlated with plasma LH and E2, suggesting a strong linkage between central beta-EP levels and pituitary-gonadal axis hormones.

Ibopamine-induced reduction of serum prolactin level and milk secretion in puerperal women.

Ibopamine, a peripheral dopamine agonist, was administered to 80 postpartum women to assess its effect on prolactin (PRL) and milk production. The acute administration of 400 mg significantly decreased serum PRL for more than 240 min. Women given ibopamine 400 mg t.d.s. for 5 to 10 days showed suppression of PRL and milk letdown was prevented in the latter group. No side effects were observed on repeated administration. Ibopamine may be a useful alternative to other dopaminergic compounds for the inhibition of puerperal lactation.

[Determination of squamous cell carcinoma antigen in the blood of patients with cancer of the uterine cervix]. / Dossaggio dell'antigene "Carcinoma squamocellulare" (SCC) nel siero di pazienti affette da cancro del collo dell'utero.

The RIA method has been used to assay the squamous cell carcinoma antigen in the serum of twenty-four patients suffering from cervical cancer. The results obtained showed expressive differences between the levels in women with metastatic relapse and in those in remission, but the SCC antigen is particularly useful in the therapeutic monitoring, since it can assess of the current treatment.