Impact of highly purified urinary FSH and recombinant FSH on haemostasis: an open-label, randomized, controlled trial.

BACKGROUND: It has recently been suggested that recombinant FSH administration may result in an increased risk of venous thrombosis. An open-label, randomized, controlled trial was carried out to compare the impact of urinary and recombinant FSH on haemostasis. METHODS: Fifty infertile women were randomized, using a random number generator on a personal computer, to receive either highly purified urinary FSH (u-hFSH) or recombinant human FSH (r-hFSH); a starting dose of 150 IU. Human chorionic gonadotrophin 10000 IU was administered once there was at least one follicle > or =18 mm. The luteal phase was supported with progesterone 50 mg/day for at least 15 days. Fifty normally menstruating women were recruited as controls. Repeated measurements of estradiol, progesterone, prothrombin time (PT) expressed as INR, activated partial thromboplastin time (APTT) ratio, fibrinogen (FBG), factor VIII (FVIII), normalized activated protein C ratio (nAPC ratio), antithrombin III activity (AT), protein C activity (PC), protein S activity (PS), tissue-type plasminogen activator antigen (t-PA), type 1 plasminogen activator inhibitor (PAI), prothrombin fragments 1+2 (F1+2), were performed during both hyperstimulated and natural cycles, and at onset of the following menstruation or at 8 weeks of pregnancy. RESULTS: At the end of gonadotrophin administration PT INR increased in the u-hFSH group, while AT and t-PA significantly decreased. In the patients treated with r-hFSH, only F1+2 significantly decreased. No significant changes were observed in the control group. In the luteal phase FBG increased significantly in all groups. In the u-hFSH group no other significant changes were noted compared to pre-ovulatory values, while compared to baseline values AT, PS and t-PA significantly decreased. In the r-hFSH group during the luteal phase PT INR significantly decreased, but did not differ from baseline levels. Other parameters such as FBG, FVIII, t-PA, rose significantly, but only FVIII and FBG values were significantly higher than baseline levels. In the women who became pregnant a significant increase in t-PA and a significant decrease in PS at the midluteal phase were observed. After one month all the haemostatic parameters returned to baseline value if pregnancy failed to occur, while in the pregnant women a significant increase in FVIII and a significant decrease in PS were observed. CONCLUSIONS: Ovarian stimulation with recombinant FSH does not influence coagulation and fibrinolysis significantly, as already reported for urinary gonadotrophins. The moderate changes induced by both treatments are no longer detectable after 4 weeks.

[Postpartum perineal assessment]. / Valutazione perineale postpartum.

BACKGROUND: To evaluate the incidence of urogenital and anorectal dysfunctions during puerperium, verify the correlation between obstetric perineal damage observed during labour and puerperal symptoms, test the efficacy of tests to evaluate perineal function in pelvic floor dysfunctions consequent to vaginal birth. METHODS: A total of 693 consecutive puerperae were recruited two months after birth. All completed a clinical and anamnestic questionnaire and underwent clinical urogynecological examination, digital test, vaginal manometry and uroflowmetric evaluation of the voluntary capacity to interrupt micturition. From a statistical point of view, persistent urinary incontinence was identified by graphic representation on frequency tables and predictive tests, and statistical "kappa" was used to evaluate the correlation between perineal function tests. RESULTS: Stress urinary incontinence (15.1%) represents the most widespread symptom, a postpartum perineal inspection provides a sufficiently accurate estimate of posterior damage, but does not identify those puerperae who will develop urinary incontinence. None of the tests used was able to predict persistant urinary incontinence. CONCLUSIONS: Postpartum perineal inspection seems to be effective in predicting anorectal dysfunctions, but is not so useful for urethro-vesical disorders. None of the diagnostic methods examined allowed a sufficiently accurate selection of those puerperae at risk.

The urine stream interruption test and pelvic muscle function in the puerperium.

OBJECTIVES: This study assesses the role of the uroflowmetric urine stream interruption test (UST) in the evaluation of postpartum pelvic floor muscle function. METHOD: Two months after vaginal delivery, 492 women who underwent a digital test, vaginal manometry, and a UST were divided into two groups: continent and incontinent. Variables were subjected to the Student's t-test and to Fisher's exact test to verify the difference between the two groups. RESULTS: Digital test and vaginal manometry results were higher in the continent group, but only the UST showed significantly different values (P=0.001). All test results of incontinent puerperae who underwent rehabilitation were significantly improved after treatment. CONCLUSIONS: UST is low cost, non-invasive, and can give objective information about pelvic floor performance after a vaginal delivery. It can be used for both routine clinical use and an outcome measure for women who undergo rehabilitation treatment.

[Urinary disorders in the puerperium. Study of the major risk factors]. / I disturbi urinari dell'età puerperale. Studio dei maggiori fattori di rischio.

BACKGROUND: There is a very wide range of genitourinary disorders which can follow vaginal birth, including slight and occasional problems as well as serious disorders which could affect a woman's social and sexual life, for example the effects of dyspareunia on a woman's sexual identity, social marginalization as an inevitable result of symptoms like urinary incontinence, urgency and fecal incontinence. The aim of this study was to identify elements which may be of use in understanding the pathogenetic mechanisms of these disorders. METHODS: Three weeks after birth 537 mothers underwent a clinical genitourinary evaluation including: collection of data regarding pregnancy development and birth, genitourinary history (urinary problem data collected in accordance with the proposal of the International Continence Society), an objective genitourinary examination with a PC-test and identification of possible antagonist abdominal-diaphragmatic muscular synergies, instrumental tests in cases of post-partum urinary incontinence. RESULTS: Maternal age at birth, parity, weight before pregnancy and at term, weight increase, gestational age, duration of the second stage of labour, development and characteristics of birth, perineal condition and neonatal weight were the variables considered as risk factors while genuine stress urinary incontinence, urge incontinence, frequency, urgency, dysuria and inability to interrupt urination were the disorders whose dependence on the various risk factors were to be studied. The analysis of the association of the various pairs of variables recorded both positive and negative correlations, whether the population taken was that of all puerperae or that of only primiparae. CONCLUSIONS: Maternal age at birth, parity and duration of the second stage of labour, even if not always separable from other co-existing risk conditions, are the main responsible risk factors in the pathogenesis of urination disorders in puerperium. These results once again confirm the fundamental role of birth in the pathogenesis of female pelvic statics anomalies and of the genitourinary disorders which are their most evident chemical demonstration.

[Post-partum urogenital and perineal prolapse]. / Il descensus urogenitale e perineale nel postpartum.

BACKGROUND: It is well known that vaginal birth, even under apparently normal circumstances, involves a significant mechanical straining of the various muscular connective structures which make up the pelvic floor and that an unusual strain of the perineal plates can cause morphologic-functional alterations which are not entirely reversible. The integrity of structures which make up the "pelvic floor" and the "endopelvic fascia" is the fundamental element to maintaining a normal anatomic position of the pelvic organs in the various functional conditions. Consequently prolapse of female pelvic organs can be linked back to the functional limitations of perineal plates (muscular support fascia system) and/or of the ligaments of the sub-peritoneal endopelvic connective tissue (ligament suspension system). METHODS: After birth 537 mothers underwent a urological and gynecological examinations as follows: collection of clinical data regarding pregnancy development and birth; medical history regarding the number of day- and night-time urinations, urinary volume, possible encouraging factors and pre-urinary sensations; objective urological and gynecological examination (pubo-coccygeal test, highlighting of possible agonistic and antagonistic muscular synergies, stress test, evaluation and staging of vaginal prolapse according to Baden and Walker; instrumental evaluation in cases of post-partum urinary incontinence. Simple regression analyses were carried out where prolapse of various vaginal segments were proportionately related to the various risk factors. RESULTS: Maternal age at birth, parity, weight before pregnancy and at term, weight increase, duration of second stage of labour, development and characteristics of the birth, perineal condition and neonatal weight were all variables considered risk factors while prolapse in each vaginal segment, PC-test, involuntary reflex execution of opposite command and uterine retroversion were all "response variables" whose dependence on various risk factors was studied. Analysis of the associations between the various pairs of variables showed a correlation, both positive and negative, whether the population considered was that of all mothers or that of primiparae. CONCLUSIONS: In the light of the results of this study, it can be said that there are two important pathogenetic factors: the tissue factors and the iatrogenic factor. Elevated maternal age and multiparity underline the role of the tissue factor in the pathogenesis of obstetric perineal damage. With regard to the iatrogenic factor it is interesting to note a higher concentration of symptomatic women cases where labour had been induced or birth had been achieved through instrumental delivery.

[Ultrasonographic assessment of urethrovesical mobility in women]. / Valutazione ecografica della mobilità uretrovescicale nella donna.

It is widely accepted that preoperative evaluation of women with stress urinary incontinence should include an assessment of urethrovesical mobility. In the last few decades a variety of methods have been used to this purpose: the so-called Q-tip test, radiologic techniques and ultrasonic studies. Transvaginal and perineal ultrasonography allows the assessment of bladder neck and urethral axis mobility at rest, during cough, Valsalva maneuvre and pelvic floor contraction. The technique is simple, not invasive and without discomfort for the patients. Aim of this study is to assess the reproducibility of an ultrasonic technique that allows the measurement of bladder neck mobility (alpha-angle variation) and the angle of the mobile proximal tract of urethra (beta-angle). A total of 58 women were included: 23 with stress incontinence and 35 continent and asymptomatic controls. The technique allows reproducible measurement of alpha and beta angles. In stress incontinent group bladder neck mobility is significantly larger while urethral angle (beta-angle) is significantly smaller and is lowered by straining.

[Anthropometric skin-fold and impedance measurement assessment of the maternal nutritional status at the end of pregnancy. Comments deduced from a study of 54 cases]. / Valutazione antropoplicometrica ed impedenziometrica dello stato nutrizionale materno al termine della gravidanza. Considerazioni dedotte dallo studio di 54 casi.

BACKGROUND: It is generally accepted that an optimal maternal weight gain is indicative of a normal course of pregnancy. Nevertheless, evaluations of nutritional status should not be limited to the periodic body weight measurement alone, they should rather include the measurement of anthropoplicometric parameters more strictly associated with the variations of the different body components (fat mass, fat-free mass and body water). Therefore, it seems necessary to define standard parameters, such as to allow the attribution of a clinical value to the anthropometric variations that can be measured during pregnancy. In this study we preliminarily proposed to survey maternal nutritional status in a group of women examined in the second day after delivery. MATERIALS AND METHODS: Anthropoplicometric parameters and bioelectric impedance measurements were evaluated in order to study nutritional status of 54 puerperae within 48 hours after delivery. A linear regression analysis was carried out examining the relationship of anthropoplicometric measurements with gestational weight gain and post-partum impedance parameters. RESULTS AND CONCLUSIONS: The results of this study lead to believe that a correct examination of maternal nutritional status must necessarily include not only weight and body mass index, but also an accurate and periodic anthropoplicometric evaluation including limb circumferences and triceps plica.

[The role of pelvic outlet dystocia in the pathogenesis of pelvic floor damage cause by obstetric intervention]. / Ruolo delle distocie dell'egresso pelvico nella patogenesi del danno perineale ostetrico.

BACKGROUND: Vaginal delivery may cause injury to the perineum even when it progresses normally. In the light of this, some authors have suggested that other factors besides obstetric trauma may be implicated in the pathogenesis of genito-urinary prolapse, such as maternal constitution, race, connective tissue characteristics, etc. The aim of this study was to investigate the role of mechanical factors in causing perineal injury. METHODS: We examined the clinical data of 250 women who underwent, 20 days after delivery, a clinical examination consisting of a semeiological study of micturition and a functional evaluation of the pelvic floor. RESULTS: Outlet dystocia seems to be associated with the higher prevalence of anteriormedian prolapse and seem to play an important role in the pathogenesis of post-partum pelvic floor deficiency. CONCLUSIONS: If valid prognostic indexes for the selection of patients at risk are found, it will be possible to carry out an effective prevention of pelvic floor damage and also to avoid an indiscriminante and unjustified increase of laparotomic deliveries.

[Prevention of obstetrical damage to the perineum. Proposal for a fetal-pelvic index for the selection of parturients at risk]. / Prevenzione del danno perineale ostetrico. Proposta di un indice feto-pelvico per la selezione delle partorienti a rischio.

BACKGROUND: According to some authors, vaginal delivery always causes denervation of perineum and the greater the damage the longer the second labour phase (the so-called "delivering phase"). Therefore, it is necessary to reduce the number of too prolonged labours, but it is equally important to avoid an uncontrolled increase of cesarean sections. In order to achieve this objective, it is important to carry out a careful selection among laboring women and choose those most at risk for whom cesarean section is strongly recommended. On the basis of the data collected by the medical literature and in consideration of the pathogenetic role of the outlet dystocia, we have tried to identify a simple and effective prognostic index resulting from the different pelvimetric and ultrasonographic parameters. METHODS: In 72 full-term pregnant women, we have taken into account the ultrasonographic parameters expressing the fetal dimension (cephalic diameters, cephalic and abdominal circumferences, estimated fetal weight according to Haddlok), the outlet pelvic diameters (trans-ischial and coccygeal-pubic) and a fetal-pelvic index derived from these parameters. RESULTS: If taken individually, these parameters do not seem to have any direct connection with the length of the delivering phase, but the combination of the cephalic and external pelvimetric diameters has produced a significative statistical coefficient. CONCLUSIONS: On the basis of the data collected, it is suggested that a careful evaluation of external pelvimetric and cephalic parameters would be useful from the clinical point of view.

[Insulinemic response to oral glucose loading tests in screening for diabetes in pregnancy]. / Risposta insulinemica al carico orale di glucosio nei test di screening del diabete gestazionale.

BACKGROUND AND AIMS: Given that an increased peripheral insensitivity to insulin represents the primum movens of gestational diabetes, it is reasonable to suppose that the determination and evaluation of the insulinemic response to an oral glucose loading test may represent a simple, effective and low cost screenign test. A method was devised which consisted in performing two assays of insulin and glycemia in venous blood; the first while fasting, the second one hour after the ingestion per os of 50 g glucose. METHODS: A group of 79 pregnant women, aged between 20 and 41 years old (mean age 30.5), was tested in around the 23rd week of gestation. All women were attending the Obstetric and Gynecological Clinic at Trieste University. RESULTS: Based on the results obtained, insulinemic parameters appear to be significantly correlated with data for the short glycemic curve according to O'Sullivan-Mahan. CONCLUSIONS: This study appears to confirm the need to include insulinemic tests as part of the new and more efficacious glucose tolerance tests and to perform prospective studies in order to identify the most reliable screening method in terms of sensitivity and specificity, also in relation to the cost-benefit ratio.

[Seasonal incidence of extrauterine pregnancy]. / Incidenza stagionale delle gravidanze extrauterine.

Ectopic pregnancy (EP) is becoming a more and more frequent problem in many developed countries, but the cause of such increase is not fully understood. Improved diagnosis certainly explains part of it, but also the changing lifestyle and sexual habits might play an important role. During the years 1990-1993, 56 women were admitted into the Divisione di Ostetricia e Ginecologia of the Istituto per l'Infanzia of Trieste because of EP diagnosed on the basis of clinical history and signs, transvaginal echography and serum HCG levels. 33 of them underwent surgical operation for the presence of severe abdominal pain, hemoperitoneum greater than 50 cc, and increases HCG level. The other 23 women were treated conservatively. Taking into account the approximate date of conception both for ectopic and other pregnancies, the monthly incidence of EP was computed and showed a statistically significant peak during the summer period (14.4%) compared to the other periods (6%). The increased frequency of EP among pregnancies started during the warmer months is interesting not only as a descriptive result, but also because it may contribute to a better understanding of the conditions under which the ectopic development of the fertilized ovum may take place.

[The donation of autologous blood in pregnancy. Observations on its safety and the cost-benefit relationship]. / Riserva di sangue autologo in gravidanza. Considerazioni sull'innocuità e sul rapporto costi-benefici.

Experience with the collection of autologous blood during the last part of pregnancy in 57 women is reported. The authors confirm the safety of the autologous transfusion program but come to the conclusion that, with current entrance criteria, the cost-benefit ratio seems unfavourable. Therefore they suggest: a) the sole involvement of women with real potential hemorrhagic complications (placenta previa, multiple pregnancy); b) the collection, when possible, of at least 2 units of autologous blood.

[The importance and limits of laboratory tests for evaluating the transplacental passage of fetal erythrocytes into the maternal circulation]. / Importanza e limiti dei test di laboratorio per valutare il passaggio transplacentare di emazie fetali nel circolo materno.

The KBB acid elution test is used to assess the presence and extent of transplacental passage of fetal cells into the maternal circulation both as a diagnostic aid in detecting hemorrhage before birth and in monitoring pregnancies at risk for hemolytic disease of the newborn. However the technique is ineffective when an hereditary Hb-pathy with associated increase in HbF is present in the mother, like the HPFH, delta-beta thalassemia and other hereditary abnormal hemoglobins. A mother with HPFH and another mother with delta-beta thalassemia with false positive result of the acid-elution test are described and the need for an extension of the clinical and laboratory study in families with hereditary HbF disorder is stressed.

Immunological study of vulvar lichen sclerosus: preliminary considerations.

Sclero-atrophic lichen (LSA) is a dermatosis that is well defined from the clinical and histological viewpoints, but the etiology remains unknown. The main symptom is a permanent pruritus which results in a gynecological consultation. We have studied the immunological status of 48 patients with LSA and 33 controls. The LSA patients showed a significant diminution of peripheral CD3 and CD1 and tissue CD2, CD3, CD1 and CD8. There was no difference of IgG, IgM or tissue C3c, or serum C3c and C4. These patients also had a higher incidence of autoantibodies.

[Fetal bradycardia during the second stage of labor. Study of 72 cases]. / Bradicardia fetale durante il secondo stadio del travaglio. Studio condotto su 72 casi.

The Authors analyse cardiotocographic patterns characterized by a constant frequency level below 120 beats/minute during the second stage of labour. Some aspects of "terminal bradycardia" (length, amplitude of oscillations, fetal heart rate in the 30 minutes preceding the onset of bradycardia) are related with the condition of the newborn (1st and 5th minute Apgar-score). Terminal bradycardia (Fischer 3, Melchior 2, 3 and 4, 2nd and 4th of Thiery) seems to have an unfavourable prognostic value especially when prolonged (more than 20 minutes), associated with low base-line variability and when cardiotocographic pattern previous to the fall of frequency is characterized by variable and late decelerations.

[Prediction of EPH gestosis by means of the roll-over test. Clinical contribution]. / Predizione della gestosi EPH mediante roll-over test. Contributo clinico.

Roll-over test (ROT) was performed on 128 selected nulliparous women between 28 and 32 weeks of gestation. Considering the high frequency of true-positive (81.5%) and true-negative results (88.1%), ROT seems to show, in clinical practice, a good sensitivity (64.7%) and an excellent specificity (94.7%). The and an excellent specificity (94.7%). The results of this study confirm that ROT is a true predictor of pregnant women at risk for future development of EPH gestosis.

[Schistosomiasis: possible cause of ectopic pregnancy. Four clinical cases]. / Schistosomiasi: possibile causa di gravidanza ectopica. Quattro casi clinici.

The Authors describe 4 cases of ectopic pregnancy associated with foci of schistosomiasis and point out the relevance of mass screening on urine, stool and vaginal secretions in those areas where schistosomiasis is endemic and frequent the involvement of female genital tract. Utilization of laparoscopy in all cases where as adnexal mass and/or a history of unexplained infertility is found is finally advocated.

[Functional evaluation of the perineum in pregnancy. Hypertonia of the levator ani muscles]. / Valutazione funzionale del perineo in gravidanza. L'ipertonia dei muscoli elevatori dell'ano.

In this study, the role of "levator ani muscles hypertonia" among pathogenetic factors of perineal obstetric injuries is analysed. For this purpose, clinical data of 142 pregnant women, who underwent functional evaluation of perineum during pregnancy and 30 days after delivery were examined. Data here reported are not sufficient to confirm the importance of this factor within the pathogenesis of postpartum perineal deficiency. Levator ani hypertonia on one hand seems to be able to obstruct fetal progression, on the other hand it presumably constitutes, as an expression of a good voluntary control of perineal muscles, a favourable prognostic factor.

[Functional evaluation of the perineum in pregnancy. Inversion of control]. / Valutazione funzionale del perineo in gravidanza. L'inversione del comando.

This study concerns clinical data of 142 women, who were subjected to functional evaluation of perineum during the last part of pregnancy. The 16 cases characterized by synergic activation, during the examination of perineal muscles ("perineal testing"), of antagonist muscles ("inverted control"), were examined taking into account data regarding evolution of labour and perineal outcome. "Inverted control" seems to influence, in this study, length of the second stage and frequency of operative deliveries whereas we can't confirm the importance of this disorder within pathogenesis of perineal obstetric complications.

[Monitoring of protracted pregnancy. Comparison of two methods]. / Monitoraggio della gravidanza protratta. Due metodiche a confronto.

Antepartum cardiotocographic patterns (NsT:Nonstress Test) and echographic assessments of amniotic fluid pockets were retrospectively analysed in 63 postdate pregnancies. The results of NsT (Fisher-score) and ecographic examinations were correlated with obstetric outcome (5 minutes Apgar-score). Ecographic assessments of amniotic volumes seem more effective than NsT for the lower frequency of false-positive results. Anyhow, considering the low sensibility of NsT and Echography separatedly considered, the Authors suggest a simultaneous valuation of the two tests.