Estroprogestin vs. gonadotrophin agonists plus estroprogestin in the treatment of endometriosis-related pelvic pain: a randomized trial. Gruppo Italiano per lo Studio dell'Endometriosi.

OBJECTIVE: This is a randomized clinical trial comparing estroprogestin (E/P) pill given for 12 months vs. gonadotrophin releasing hormone agonist (GNRHa) given for 4 months followed by E/P pill treatment for 8 months in the relief of endometriosis-related pelvic pain. METHODS: Eligible for the study were women with laparoscopically confirmed endometriosis and pelvic pain lasting 3-12 months after diagnosis. Eligible women were randomly assigned to treatment with E/P pill (gestroden 0.75 mg and ethynlestradiol 0.03 mg) for 12 months (47 patients) vs. tryptorelin 3.75 mg slow release every 28 days for 4 months followed by E/P pill for 8 months (55 patients). RESULTS: At baseline, dysmenorrhea was reported in 46 women allocated to E/P pill only (97.9%), and in all the 55 women allocated to GNRHa+E/P pill. The corresponding value at the 12 months follow-up visit was 14 subjects (35.9%) and 16 subjects (34.8%). The baseline median values of the multidimensional and analog scale were for dysmenorrhea 4 and 6 in the EP only and 3 and 6 in the GNRHa+E/P group. The corresponding value at the 12 months follow-up visit were 2 and 6 and 0 and 5. Non-menstrual pain was reported, respectively, at baseline and 12 month visit by 46 (97.9%) and 15 (38.5%) subjects in the E/P pill group and 49 (89.1%) and 17 (37.0%) of the GNRHa+E/P pill one. The baseline median values of the multidimensional and analog scale were for non-menstrual pain 3 and 5 in the E/P only and 2 and 6 in the GNRHa+E/P group. The corresponding values at the 12 month follow-up visit were 0 and 4 and 0 and 4. These differences between the two groups were not statistically significant. CONCLUSIONS: 1 year after randomization, the two treatment schedules show similar relief of pelvic pain in women with endometriosis.

A randomized comparison of vaginal prostaglandin E2 with oxytocin plus amniotomy for induction of labour in women with intermediately ripe cervices.

OBJECTIVE: To compare the effects of oxytocin and amniotomy or vaginal prostaglandin E2 (PGE2) for induction of labour. STUDY DESIGN: We conducted a randomized clinical trial. Eligible for the trial were women with normal pregnancy, parity 0-3, with intact membranes, >40 weeks of gestation documented by ultrasound examination before 20 weeks gestation, observed in a network of 13 general and teaching hospitals in Italy. Inclusion criteria were cervical Bishop's score 5-7, less than six uterine contractions per hour, single pregnancy, cephalic presentation, no history of cesarean section and uterine surgery. Eligible women were randomly assigned by phone to oxytocin plus amniotomy (163 women) or vaginal PGE2 2 mg, two doses at 6-h intervals (157 women). RESULTS: Overall, 50 women (15.6%) delivered by cesarean section, 22 (13.5%) randomized to oxytocin, and 28 (17.8%) randomized to PGE2 (not significant). Twelve hours after randomization, induction had failed in 26 women of the 163 randomized to oxytocin plus amniotomy (21.6%) and 34 out of the 157 randomized to PGE2 (15.9%): the difference was not significant. Neonatal outcome was similar in the two groups. CONCLUSIONS: This study did not find marked differences in labour and neonatal outcome between women randomized to oxytocin plus amniotomy or vaginal PGE2. A shorter induction delivery interval in the group receiving amniotomy and oxytocin after PGE2 priming was observed.

Bacterial vaginosis in pregnancy and preterm birth: evidence from the literature.

We review below the evidence from the literature about the relationships between bacterial vaginosis, its treatment and pregnancy outcome. The literature indicates that there is a well-defined association between the presence of bacterial vaginosis during pregnancy and the risk of premature membrane rupture and preterm birth. Less definite is the role of the treatment of such pathology in reducing the frequency of preterm birth and/or premature rupture of membranes. The results of the controlled clinical trials are not entirely consistent. Of the most studied therapies, clindamycin seems to have shown favourable results most consistently but the published data are limited to trials including just a few hundred subjects. Only the availability of further data from controlled clinical trials will clarify the role of such treatment for bacterial vaginosis in pregnancy.

Hemostatic parameters and platelet activation by flow-cytometry in normal pregnancy: a longitudinal study.

Nineteen pregnant women with uncomplicated pregnancies were studied during the first, second, and third trimesters. We measured the following hemostatic parameters: prothrombin time, activated partial thromboplastin time, fibrinogen, antithrombin III, protein C, protein S, platelet number and volume. Platelet function was examined by a cytofluorimetric method, using an anti-GPM-140 antibody which is directed against a platelet alpha granule membrane protein. Activated platelets were expressed as a percentage of the GMP-140-positive platelets over total platelets. Fibrinogen levels showed a steady increase during pregnancy; conversely prothrombin time, activated partial thromboplastin time, protein C, and antithrombin III showed no significant modifications and remained within the reference range. There was a decrease of protein S activity throughout pregnancy, although protein S antigen did not follow this trend. The decrease occurred early in pregnancy and persisted during the second and third trimesters, reaching a stable plateau. We observed no platelet volume change or activation: the percentage of activated platelets was within the normal reference range, even in late pregnancy.

Social class, prenatal care, maternal age and parity: a study of their interrelation in six Italian centres.

"Multiple Correspondence Analysis was used to describe the complex structure formed by those sociodemographic variables, whose association with the occurrence of prenatal and neonatal deaths and diseases has been most frequently stressed in literature: social class, prenatal care, maternal age and parity. The study regards 41,537 women included in a multicentre survey of perinatal preventive medicine, which was carried out, between 1973 and 1979, in six Italian centres...." It is found that "in all centres there are distinct groups of women characterized by a set of unfavourable factors closely interrelated: low social class implies lower prenatal care, higher occurrence of precocious or belated childbearing and higher number of pregnancies, often unintended." (SUMMARY IN FRE AND ITA)

Smoking habit in pregnancy and sociodemographic background in six Italian centres.

Studies carried out in foreign countries (US and UK, mainly) indicate that maternal characteristics, such as age, parity, social class, and prenatal care, are related to child's growth, mortality, and morbidity, as well as to cigarette smoking. These characteristics may act as confounding variables in the analysis of the effects of maternal smoking on babies in fetal and neonatal periods. Until now there has been a lack of information on the subject, because even the most recent available data concern women over age 14 regardless of obstetric history. This paper deals with smoking habits, before and during pregnancy, of 37,664 women included in a multicenter survey of perinatal preventive medicine (MPPI), which was performed in 6 Italian centres (Trieste, Milan, Parma, Rome, Naples, Bari) between 1973 and 1979, with the financial support of the Italian National Research Council. The results of the MPPI and other surveys are compared and the association between maternal smoking habits and sociodemographic background is investigated by multiple correspondence analysis. As to Italy, unlike UK and US, in the 1970s women of high social status show the highest prevalence of the smoking habit. Moreover, in pregnancy, the large majority gives up smoking, or at least reduces it, mainly in high socioeconomic levels, so that the proportion of pregnant women who keep on smoking over 10 cigaretts per day is very low (0.5-3.8%) and poorly related to sociodemographic factors. Therefore, it seems unlikely that these may exert serious confounding effects on the relationships between smoking in pregnancy and perinatal outcome.