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To evaluate the effects of an oral contraceptive containing 3 mg drospirenone (DRSP) and 30 microg ethinyl oestradiol (EE) on somatic and psychological symptoms related to water retention, and on body weight.This prospective study was performed in 26 centres in Canada over six treatment cycles. The first primary efficacy variable was the individual change in the water retention score of the Moos Menstrual Distress Questionnaire (MDQ) from baseline to the final examination in women with significant somatic symptoms related to water retention (n = 43). The second primary target variable was the change in body weight (n = 305).Forty-three women met the criteria for the first primary target variable. In the premenstrual phase, the score decreased from 6.49 (SEM 0.45) at baseline to 3.19 (SEM 0.54) at the final examination (p = 0.0001). The data for the menstrual phase were 4.70 (SEM 0.30) at baseline and 2.35 (SEM 0.32) at the final examination (p0.0001). Baseline data from 299 women were assessed for the second primary target variable. Body weight did not change significantly, having increased only by 0.14 kg (SEM 0.13) at the final visit (p = 0.3082).An oral contraceptive containing 3 mg DRSP and 30 microg EE significantly reduced the clinical symptoms of water retention. Body weight did not change.

Objective: To investigate the perinatal factors related to neonatal intracerebral hemorrhage (ICH) and possibly to define obstetric and perinatal risk factors. Study design: All medical records of women who delivered in the period from 1 January 1991 to 1 January 2000 were reviewed for intracerebral hemorrhages in infants born between 24 and 34 weeks of gestation and treated in the postnatal period. Sixty infants with ICH (Group I) and 60 infants without ICH (Group II, matched controls) were determined for comparison. Obstetrical parameters and risk factors and perinatal outcome parameters were evaluated and statistically analyzed. Results: Neonatal intracerebral hemorrhage prevalence was 0.8% (60/7635 births). Betamethasone administration was significantly less in Group I than in Group II (27% versus 46%). Although Doppler-sonography of the middle cerebral artery was performed in a minority of the cases, it showed a significant tendency of lower resistance indices (brain sparing) in the intracerebral hemorrhage group (66.7% versus 21.1%). Postnatally, infants with intracerebral hemorrhage showed a significantly more often umbilical arterial acidosis (18% versus 10%), a greater base deficit, lower median 5 min Apgar scores (6 and 8, respectively for Groups I and II), and a lower thrombocyte count (Group I 190,000 ± 76,000 µl-1, and Group II 227,000 ± 96,000 µl-1). Infants in Group I were more often (93% versus 76%) and longer (26.7 ± 30.5 days versus 15.4 ± 11.7 days) dependent on ventilatory support than infants in Group II. Mortality rate in Group I (35%) was significantly higher compared to Group II (17%). Conclusions: Antenatal Doppler sonography in predicting intracerebral hemorrhage in preterm infants should be investigated in large scale prospective studies. Postnatal low pH-values (pH < 7.1) and a base deficit of more than -16 mmol/L in the umbilical artery, low Apgar scores and thrombocytopenia are associated with a neonatal intracerebral hemorrhage and prophylaxis with corticosteroids reduces the risk for it. A higher neonatal mortality and morbidity, including neurological and neuromotoric dysfunctions is expected in this clinical entity. © 2004 Elsevier Ireland Ltd. All rights reserved.

Objective Higher risks of infertility have been found in overweight women. The purpose of the present study was to explore whether protein metabolism profiles related to body mass index (BMI) and to find out whether these parameters should affect IVF/ICSI outcome. Patients and methods 52 patients were enrolled in this study. All patients underwent an ovarian stimulation either with recombinant follicle stimulating hormone (Gonal-F) or human menopausal gonadotropin (Menogon) after pituitary down-regulation with Goserelin (Zoladex) or Triptorelin (Decapeptyl Gyn). Five blood samples were taken: before treatment, at the beginning of ovarian stimulation, on the day of HCG injection for the ovulation induction, on the day of follicle aspiration and 14 days after embryo transfer. The blood samples were analysed with regard to the serum concentrations of total protein, albumin, total bilirubin and urea. According to the BMI values the patients were divided into two groups: BMI 25 kg/m (2) (GII, n = 24). The results of IVF/ICSI outcome were compared in both groups. Results In both groups, the serum concentrations of total protein, albumin, total bilirubin and urea decreased during ovarian stimulation. In GII, albumin concentration decreased significantly on the day of follicle aspiration (46.0 +/- 2.3 g/l versus 43.5 +/- 2.5 g/l, p 25 kg/m (2) 33.1 % (p = 0.34). Conclusions Serum concentrations of albumin and total bilirubin are influenced by BMI. Excess weight defined as BMI > 25 kg/m (2) has a negative impact on IVF outcome leading to decreased chances of pregnancy.

BACKGROUND Prematurity is a main issue in modern obstetrical care. The purpose of the present study was to evaluate the perinatal outcome of premature infants weighing less than 1500 g according to the mode of delivery. PATIENTS AND METHODS 122 patients with infants weighing less than 1500 g were enrolled in this retrospective study (26 to 32 weeks of gestation). The perinatal outcomes of 26 infants born by vaginal delivery were compared to 96 infants delivered by caesarean section. RESULTS The rates of rupture of membranes, preterm labour and intravenous tocolysis were significantly increased in patients after vaginal delivery. Preeclampsia and pathological cardiotocograms were increased in patients after caesarean section. Infants born by vaginal delivery showed a significant increase of peri- and intraventricular haemorrhage grade III, periventricular leukomalacia, C-reactive protein 24 hours postpartum and mortality until the seventh day of life. However, the rate of bronchopulmonary dysplasia was significantly increased in infants born by caesarean section (p < 0.05). CONCLUSIONS These data suggest that the mode of delivery affects the perinatal outcome of infants weighing less than 1500 g. Based on the results of the present study, it appears unclear which mode of delivery should be preferred, depending on particular material and fetal factors.

UNLABELLED BACKGROUND/PATIENTS: A reverse flow in the umbilical artery and/or fetal aorta is associated with a higher perinatal and neonatal mortality. 30 fetuses showed a reverse flow using pulsed wave Doppler sonography (group I). A matched-pair control group including 30 fetuses with the same gestational age as well as a normal Doppler flow pattern in the umbilical artery and/or fetal aorta was taken for comparison (group II). RESULTS In the group with reverse flow the rates of pregnancies with pre-eclampsia (n = 19/30, p < 0.0001), intrauterine growth retardation (n = 25/30, p < 0.0001), oligohydramnios (n = 21/30, p < 0.0001) and nicotine abuse (n = 15/30, p < 0.01) were significantly higher compared to the control group. Postnatal data showed significantly lower pH values in group I (p < 0.01). 40 % of the fetuses with reverse flow died in utero whereas in 67 % the reverse flow was accompanied by an insufficiency of the placenta (IUGR, oligohydramnios, histopathological abnormalities of the placenta). None of the fetuses in the control group died in utero. The incidence of IUGR (< 5ht percentile) was 83 % in group I but only 3 % in group II. The perinatal and overall mortality (including neonatal mortality 7 - 28 days after birth) amounted to 27 % and 53 % in group I, respectively, compared to 3 % and 0 % in the control group (p < 0.001). In addition cerebral anomalies could be found by ultrasound in 50 % of the neonates who presented a reverse flow prenatally. In 28 % of the surviving newborns an intracerebral hemorrhage (ICH) could be detected. None of the newborns of group II developed an ICH. CONCLUSIONS Pregnancies with a reverse flow in the umbilical artery and/or fetal aorta have to be considered as a high risk group with a poor prognosis. The reverse flow is mainly caused by chronic placental insufficiency with IUGR. With respect to the further neuromotor development the incidence and severity of cerebral lesions in affected fetuses should be considered when discussing the perinatal situation with the parents.

The aim of this prospective study was to assess the role of uterine artery color Doppler waveform analysis in the prediction of adverse pregnancy outcome such as preeclampsia, intrauterine growth retardation, placental abruption or a combination of outcome parameters in risk pregnancies (n=52).Various uterine artery Doppler ultrasound parameters (resistance index (RI)0.58, RI0.7 and uni/bilateral or bilateral notching) were tested. The mean time of delivery was 37+1 weeks' gestation. Six newborns (12%) were delivered before 34 weeks of gestation. The mean birth weight was 2,910 g. Dystrophic fetuses (10% percentile) were registered in 7 cases (13%). In 11 of the 52 women (21%) a cesarean section was performed because of abnormal fetal heart recording.Preeclampsia was diagnosed in 4 cases (8%). In 4 cases (8%) an intrauterine fetal death was diagnosed. Placental abruption did not occur. The sensitivity of notching for the prediction of preeclampsia and for the prediction of a severe pregnancy complication was 75 and 69% with relative risks of 2.7 and 2.0. The sensitivity of notching in the uterine arteries for developing an intrauterine growth retardation (IUGR) was 71% with a relative risk of 2.2. The sensitivity of RI0.58 in the uterine arteries for developing an IUGR was 67% with a relative risk of 5.4. The sensitivity of RI0.58 for the prediction of preeclampsia, of intrauterine death and for the prediction of a severe pregnancy complication was 50, 75 and 80% with relative risks of 2.7, 8.1 and 10.9 respectively.The results of this study suggest that Doppler ultrasound of the uterine artery in the second trimester of gestation is a useful method to predict abnormal outcomes in risk pregnancies, with high negative predictive values.

In this first prospective, double-blind, randomized, parallel-group study we evaluated the influence of two combined oral contraceptives on bone mineral density (BMD) and metabolic bone parameters. One dose-reduced preparation contained 20 microg ethinylestradiol (EE) in combination with 100 microg levonorgestrel (LNG) (20/100) was compared with the reference preparation which contained 30 microg EE in combination with 150 microg LNG (30/150). Data from 48 volunteers aged 20-35 years were obtained over an observation period of 36 treatment cycles. The direction of the change (increase or decrease) in all investigated bone-related variables was similar in both treatment groups. As compared to baseline, bone mineral density decreased by 0.4% in the 20/100 group and by 0.8% in the 30/150 group after 36 treatment cycles. These changes were not significantly different between the two treatment groups (p = 0.902). For bone-specific alkaline phosphatase, we measured a mean increase of 55.4% (20/100 group) and of 113.2% (30/150 group) after 36 treatment cycles. The two treatments did not differ statistically significantly (p = 0.522). With respect to cross-linked N-telopeptides (NTx), we detected a decrease of the mean NTx urine concentrations of 21.1% (20/100) and of 13.4% (30/150). These changes also did not significantly differ between the two treatments (p = 0.613). Both study treatments were safe and well-tolerated by all volunteers participating in the study. In conclusion, BMD did not change during the 3-year observation period. Thus, both trial preparations containing either 20 or 30 microg EE in combination with LNG were capable of maintaining BMD in young fertile women. There is no reason to assume that the EE dose reduction had any negative impact on BMD. Because there were no differences in BMD between the treatment groups, it can be assumed that even lower dosages than 20 microg EE might be sufficient for bone protection. Biochemical markers provided evidence for a reduced bone resorption.

OBJECTIVE The ovarian stimulation increase the estradiol concentration in comparison to the one observed in the menstrual cycle. The aim of the study was to determine the influence of ovarian stimulation on serum concentrations of lipids and ketone bodies in patients undergoing IVF/ICSI treatment. PATIENTS AND METHODS 50 patients were included in this study. All patients underwent an ovarian stimulation either with recombinant follicle stimulating Hormone (Gonal-F, n = 28) or human menopausal gonadotropin (Menogon, n = 22) after pituitary down-regulation with Goserelin or Triptorelin. Five blood samples were taken: before treatment, at the beginning of ovarian stimulation, on the day of HCG injection for the ovulation induction, on the day of follicle aspiration and 14 days after embryo transfer. Afterwards, the samples were analysed with regard to the concentrations of triglyceride, total-cholesterol, HDL-/LDL-cholesterol, acetoacetate, beta-hydroxybutyrate and alpha-ketoglutarate. RESULTS During the ovarian stimulation, total-cholesterol andA'LDL-cholesterol decreased significantly (p(Chol) < or = 0.001; p(LDL) < or = 0.001), whereas the concentration of HDL-cholesterol increased significantly (p(HDL) < or = 0.001). Furthermore, a significant increase of beta-hydroxybutyrate and alpha-ketoglutarate has been detected (p(HBS) = 0.039; p (KG) = 0.023). CONCLUSIONS The observed changes in serum concentrations of lipids and ketone bodies began with the application of gonadotrophins for stimulation and persisted until the end of the treatment. Therefore, the increase of estradiol, stimulated by gonadotrophins, seems to be responsible for the changes in the serum concentrations of lipids and ketone bodies. All women undergoing ovarian stimulation should be monitored for long-term thrombogenic and atherogenic risks.

Objective: The aim of this study was (i) to investigate the existence of fibroblast growth factor (FGF), soluble intracellular adhesion molecule-1 (sICAM-1), and stem cell factor (SCF) in serum and human follicular fluid (FF) of intracytoplasmic sperm injection (ICSI) patients, and (ii) to determine the relationship between these parameters and ICSI outcome. Material and method: Seventy-five patients undergoing controlled ovarian hyperstimulation with human menopausal gonadotropin (hMG) after down-regulation with GnRHa were included in this study. The concentrations of FGF, SCF, and sICAM-1 were measured by using commercially available enzyme-linked immunosorbent assay test kits. Results: The FGF, sICAM-1, and SCF concentrations in the serum of women who become pregnant (group I) were 8.5 ± 1.5 pg/mL, 235.8 ± 81.1 ng/mL, and 597.7 ± 139.9 pg/mL, and the corresponding concentrations of women who did not (group II) were 6.4 ± 3.6 pg/mL, 230.6 ± 66.5 ng/mL, and 569.6 ± 91.4 pg/mL respectively. No significant difference was observed between the two investigated groups with regard to the number of hMG ampoules administered for controlled ovarian hyperstimulation, estradiol concentration on the day of human chorionic gonadotropin (hCG) injection, number of retrieved oocytes and fertilization rate. Conclusion: The concentration of FGF, sICAM-1, and SCF did not differ significantly between the two groups in serum or in FF. Besides, the ICSI outcome was not related to their concentrations in serum or FF. Therefore, these parameters could not be used as a prognostic factor in ICSI program.

Background Fetuses with a reversed enddiastolic flow in the umbilical artery and/or aorta are at risk pregnancies and show a higher incidence of perinatal morbidity and mortality. The aim of this study was to evaluate the pathological changes in the terminal villous tree in fetuses with a reverse flow in the fetal aorta or umbilical artery. Materials and methods In this retrospective study, 16 cases with a reverse flow in the fetal aorta or umbilical artery (Gr. 1) were compared with gestational age matched 16 healthy pregnant women (Gr. 2). The following morphometric parameters were evaluated in 50 sections in each placenta (1600 measurements): mean vessel diameter, volume density of the villous tissue, stem villi and terminal villi. Measurements were performed using a computerized Video Image Analysis system. Results The mean gestational age at birth was similar in both groups (30 + 4 weeks gestation vs. 30 + 6 weeks gestation, respectively, for Gr. 1 and Gr. 2). The birth weights (985 g vs. 1780 g) and the placental weights (216 g vs. 385 g) were significantly lower in the reverse flow group. There was a significant reduction in the proportion of total villous tissue (19 % versus 45 %) and in the diameter of tissue at the terminal villi (2.1 % versus 7.6 %) in the reverse flow group. Although the mean number of vessels at the terminal villi was lower than the control group (4.1 versus 5.6), the mean and total areas of the vessels were not different. Conclusion Our observations showed a significant association between the placental morphometric parameters and reversed enddiastolic flow in the umbilical artery or fetal aorta. The reduced number of functional placental units is responsible for the diminished exchange function of the placental vessels in "reverse flow" cases. This could partially explain the adverse outcome in this clinical situation.

Problem The objective of this study was to determine the concentration of fibroblast growth factor (FGF) and soluble intracellular adhesions molecule (sICAM-1) in serum and follicular fluid (FF) of polycystic ovary (PCO), endometriosis and tubal factor infertility and male factor infertility patients, and to investigate the relationship between these parameters and the outcome of intracytoplasmic sperm injection (ICSI). Method of study The concentration of FGF and sICAM-1 in serum and FF were determined in patients undergoing controlled ovarian hyperstimulation (COH) for ICSI therapy for various etiology of infertility and the results of cytokines concentration and ICSI outcome were compared between the groups. Twenty patients with PCO (G.I), 17 with endometriosis (G.II), 19 with tubal damage (G.III) and 19 with male factor infertility (G.IV) were enrolled in this study. Quantitative determination of levels of FGF and sICAM-1 was performed using enzyme-linked immunosorbent assays (ELISAs). Results The FGF level in serum of PCO patients (G.I) were 4.8 +/- 2.3 and in FF were 104.0 +/- 39.0 pg/mL. The corresponding values in the endometriosis patients group (G.II) were 5.9 +/- 3.1 and 125.4 +/- 74.9 pg/mL. The concentration of FGF in tubal factor infertility group (G.III) in serum was significantly higher (P = 0.009) than those observed in the PCO group (G.I) 7.4 +/- 4.5 pg/mL, whereas the concentration in FF was at the same level like the other groups investigated, 128.7 +/- 75.9 pg/mL. Besides, the sICAM-1 (pg/ml) concentration in FF showed a significant difference between the groups investigated (G.I, 175.3 +/- 52.8; G.II 194.4 +/- 32.2; G.III 233.1 +/- 54.3; and G.IV 215.1 +/- 54.4 ng/mL; P = 0.003). The sICAM-1 levels in serum were not significantly different between the groups (217.0 +/- 42.9; 216.3 +/- 73.6; 254.8 +/- 79.6; 237.56 +/- 78.4 ng/ml; P = 0.267). The fertilization rate was significantly higher in G.III (66.0 +/- 23.89%) in comparison to G.II (38.8 +/- 33.9%; P = 0.014) or G.IV (38.7 +/- 22.7%; P = 0.012). The pregnancy rates were similar in all groups (30, 35.3 and 35.0, 38.6%, respectively). Conclusion Both, FGF and sICAM-1 are present in serum and FF of patients undergoing controlled ovarian hyperstimulation for ICSI therapy. The FGF concentration in serum differs significantly between the groups investigated, whereas, no significant difference could be observed in the FF concentration of FGF. On the other hand, the sICAM in serum showed no significant difference between the groups, whereas, sICAM in FF demonstrated a significant difference between the patient groups investigated. On the whole, the ICSI outcome was not related to serum or FF concentrations of FGF or sICAM-1. Therefore, the mean concentration of FGF and sICAM-1 in serum and in FF could not be used to predict the fertilization rate in an ICSI program.

OBJECTIVE The aim of this study was to compare the cytokine concentration in follicular fluid (FF) of low and high responder intracytoplasmic sperm injection (ICSI) patients and to find out the impact of these cytokines in FF on ICSI outcome. DESIGN The levels of insulin-like growth factor (IGF)-I, IL-6, IL-8, epidermal growth factor (EGF), platelet-derived growth factor (PDGF), granulocyte-macrophage-colony stimulating factor (GM-CSF) were measured from low and high responder ICSI patients, the results were compared between the two groups and their influence on ICSI outcome was analysed. MATERIAL AND METHODS A total of 49 low (G.I) and 34 high (G.II) responder patients were enrolled in this study. FF was collected at the time of oocyte retrieval and measured either by enzyme-linked immunosorbent assay (IL-6, IL8, EGF, PDGF, GM-CSF) or radio immuno assay (IGF-I). RESULTS The concentration of IL-6 (pg/mL), IL-8 (pg/mL), IGF-I (ng/mL), PDGF (pg/mL), EGF (pg/mL), GM-CSF (pg/mL) in G.I was 6.0 +/- 4.3, 288.1 +/- 139.2, 0.416 +/- 0.089, 249.8 +/- 150.1, 9.12 +/- 5.5 and 1.45 +/- 2.10 and the corresponding value in G.II was 7.4 +/- 4.8, 208.6 +/- 64.0, 0.431 +/- 0.094, 387.6 +/- 36.0, 8.9 +/- 5.4 and 1.8 +/- 3.3, respectively. Only the PDGF concentration showed a significant (P = 0.007) difference between the two groups. Besides, negative correlations were found between PDGF and fertilization rate (r = -0.287; P = 0.046) of G.I. The mean number of retrieved (6.4 +/- 2.3 versus. 15.7 +/- 5.4) and fertilized (3.6 +/- 1.6 versus 7.0 +/- 4.5) oocytes differ significantly (P = 0.001) between the two groups. The fertilization rate was significantly higher in G.I than in G.II (60.9 +/- 25.1 versus 43.4 +/- 20.7%). CONCLUSION There was no significant difference between IGF-I, IL-6, IL-8, EGF and GM-CSF concentrations of low and high responder patients. Besides, PDGF was significantly (P = 0.007) higher in high responder compared with low responder patients. Moreover, in poor responder patients, a negative correlation was found between PDGF and fertilization rate. However, the cytokine levels in FF of the patients undergoing controlled ovarian hyperstimulation for ICSI could not be used as a marker of oocyte fertilization and implantation potential.

Objective: Evaluation of the influence of postmenopausal hormone replacement therapy (HRT) on microcirculation. Patients and Methods: Using the method of video-capillary microscopy, we compared blood flow velocity in capillaries and vascular reactivity to ischaemic stress in 22 postmenopausal women under HRT receiving either estrogens only or estrogens combined with gestagens and in 24 postmenopausal women without HRT. Additionally, we analysed serum levels of estrogen and follitropin alpha, haematocrit, plasma viscosity, as well as erythrocyte and platelet aggregation. Results: Postmenopausal hormone replacement therapy leads to a significant increase (p=0.003) of 0.125mm/s (18%) of blood flow velocity in capillaries and to a significant reduction (p = 0.038) of 0.54 (29%) of the index for vascular reactivity to ischaemic stress. This reflects a vasodilatation of capillaries under HRT. The further dilatation due to ischaemic stress seems to be limited. There were no significant differences between the women receiving estrogens only compared to females taking estrogens combined with gestagens. Furthermore, we found no correlation between the serum levels of estrogens and the dynamic parameters of the microcirculatory system. Under HRT, there was a significant reduction of the erythrocyte aggregation (p = 0.011), whereas the other rheological parameters showed no significant differences. Conclusion: Postmenopausal hormone replacement therapy leads to an increased perfusion in capillaries. These changes in the microcirculatory system are most likely a result of a direct effect of female sex steroids on the vessels, whereas rheological changes seem to play a minor role in the alteration of capillary blood flow.

The aim of this study was to determine the relationship between the ovarian stimulation protocol (with HMG or FSH) after down-regulation with GnRH anologa and protein (total protein and albumin) as well as bilirubin and urea in serum. Furthermore, it was intended to find out the effect of these parameters on IVF/ICSI outcome. 50 patients were included in this study. All patients underwent controlled ovarian hyperstimulation for assisted reproduction therapy either with FSH (Gonal-F) or HMG (Menogon). Ovulation induction was induced by human chorionic gonadotrophine (HCG, Predalon) 10 000 IU i. m. The protein concentration (total protein, albumin) as well as bilirubin and urea concentrations were determined before down-regulation with GnRHa, at the beginning of ovarian stimulation with FSH or HMG, on the day of ovulation induction with HCG, during oocyte retrieval and fourteen days after embryo transfer. The age, body mass index and etiology of infertility showed no significant difference between patients stimulated with HMG or FSH. Total protein and albumin concentration decreased significantly (p=0.001) from 77.45 +/- 5.90 g/L and 47.02 +/- 3.41 g/L to 74.60 +/- 4.6 g/L and 45.04 +/- 2.39 g/L, respectively at the time of oocyte retrieval. Whereas, no significant change with bilirubin and urea concentration was observed. However, the mean concentration of total protein, albumin, bilirubin of patients who become pregnant was higher of those who did not. In conclusion, this study shows that total protein and albumin concentration in plasma decreased during the follicular phase significantly with the application of exogenous gonadotrophins and steroid hormones in comparison to the value before down-regulation. The mean value of total protein, albumin, bilirubin of patients who become pregnant was higher (but not significant) of those who did not. However, the high individual variation in the present results shows that these parameters are not useful as a predictor of IVF/ICSI outcome.

PROBLEM: The aims of this study were (i) to identify the presence and concentration of interleukin-6 (IL-6), IL-8 and granulocyte-macrophage colony-stimulating factor (GM-CSF) in pre-ovulatory follicular fluid (FF) in patients undergoing controlled ovarian hyperstimulation regimen for intracytoplasmic sperm injection (ICSI) with recombinant human follicle stimulating hormone (rFSH) (G.1), hMG (G.2) or rFSH/ hMG (G.3) treatment and (ii) to determine whether controlled ovarian hyperstimulation stimulation regimen could affect the concentration of these investigated interleukins and as a consequences the ICSI outcome. (iii) Moreover, it was intended to clarify the association between these investigated parameters and the peripheral blood level of estradiol 17-β, progesterone, leuteinizing hormone (LH) at the day of oocyte retrieval and (iv) finally to find out whether these interleukin concentrations in FF could be considered as an additional parameter for predicting fertilization and pregnancy outcome in ICSI patients. MATERIAL AND METHODS: Interleukin-6, IL-8 and GM-CSF concentrations were determined in the FF of 85 patients. The levels of these interleukins were measured by the enzyme-linked immunosorbent assay (ELISA) technique, using commercially available kits. RESULTS: Interleukin-6 (6.5 ± 4.6 pg/mL), IL-8 (222.9 ± 163.4 pg/mL) and GM-CSF (1.6 ± 2.7 pg/mL) were present in pre-ovulatory FF in ICSI patients. No significant difference in the mean concentration of IL-6, IL-8 and GM-CSF was found between the groups. Moreover, there was no correlation between these interleukin levels in FF and steroid hormone concentration in the peripheral blood. CONCLUSIONS: Interleukin-6, IL-8 and GM-CSF were found in FF of patients undergoing ovarian hyperstimulation for ICSI treatment. The stimulation protocols showed no influence on these interleukin levels in FF. Moreover, no correlation was found between these investigated interleukins and steroid hormone concentrations in peripheral blood or ICSI outcome. Therefore, the determination of interleukin level in FF of patients undergoing ovarian hyperstimulation for ICSI therapy could not be recommended as a prognostic factor for ICSI outcome.

Objective The aims of the present study were to (i) determine the presence and concentration of albumin fractions (alpha1, alpha2, beta, gamma), immunoglobulins (IgA, IgG, IgM) and cytokines [interleukin (IL)-6, IL-8, granulocyte-macrophage colony-stimulating factor (GM-CSF)] in periovulatory ovarian follicular fluid (FF) of in vitro fertilization (IVF) patients, (ii) examine the relationship between these parameters and the etiology of infertility as well as the IVF outcome and (iii) find out if these parameters in FF could be used as a predictive factor of IVF outcome. Design The levels of albumin fractions, immunoglobulin and cytokines were measured from women who underwent IVF therapy for various indications and the results were compared between the patient groups and IVF outcome. Materials and methods Follicular fluid was obtained from 160 IVF patients. A total of 79 patients underwent controlled ovarian hyperstimulations (COH) either with follicle-stimulating hormone (FSH) or HMG. Whereas, the HMG was used for the second set of patients (n=81) - after down regulation with gondotropin-releasing hormone agonists (Gn-RHa) - the protein fractions were determined using electrophoresis separation. Immunoglobulins were measured using a commercial kits and the concentration of cytokines was determined by the highly sensitive enzyme-linked immunosorbent assay (ELISA) methods. Results The stimulation regimens used have no effect on albumin (alpha1, alpha2, beta, gamma) and immunoglobulin (IgA, IgG, IgM) concentrations, as no significant difference was observed between the two groups. Besides, no specific relationship was found between the concentration of these investigated parameter in FF and etiology of infertility or fertilization, cleavage and pregnancy rate. Besides, there were no significant differences between the groups for any cytokine investigated. Moreover, there were no correlations between the concentration of IL-6, IL-8 and GM-CSF in FF and steroid hormone concentration in the blood at the day of oocytes retrieval or IVF outcome. In conclusion Total protein, albumin fraction, immunoglobulins and cytokines level in FF of patients undergoing COH for IVF therapy for various etiology of infertility could not be a useful parameter for predicting IVF outcome.

Between January 1989 and November 1996 we detected a total of 44 cases of anterior abdominal wall defects comprising 29 with an omphalocele and 15 with gastrochisis. The gestational age at antenatal diagnosis of gastrochisis (mean = 17 weeks, 95% CI = 15-19) was significantly lower than for omphalocele (mean = 19.0 weeks, 95% CI = 17-21). Whereas gastrochisis tended to occur in relatively younger mothers (mean age = 23 years), omphalocele was associated with a comparatively advanced maternal age (mean age = 28 years). The sensitivity of ultrasound detection was the same for both malformations (omphalocele = 86.2%; gastrochisis = 86.7%). Additional structural anomalies were found in a higher proportion of those with an omphalocele compared with those with gastrochisis (62% vs. 20%). All the three cases of chromosomal anomalies were detected in omphalocele fetuses with an intracorporeal liver. Perinatal mortality was higher, albeit nonsignificantly, among fetuses with omphalocele.

In this double-blind study we compared the influence of two oral contraceptives, a 23-day regimen with 20 μg ethinyl estradiol and 75 μg gestodene (23-day 20/75) and a 21-day regimen with 30 μg ethinyl estradiol and 75 μg gestodene (21-day 30/75), on hemostatic variables, lipids, and carbohydrate metabolism. The volunteers received the preparations daily for six 28-day cycles. Hemostatic variables and lipids were measured at baseline and after six treatment cycles. Carbohydrate metabolism was assessed by determination of the area under the curve (AUC) of carbohydrate parameters after oral glucose tolerance tests performed at baseline and after three treatment cycles. Data from 33 volunteers in each group were obtained. No significant differences between the effects of both treatments on the hemostatic system were detected. Neither the overall change of all hemostatic variables from baseline to treatment Cycle 6 [defined as primary target variable in the study] nor the change of any of the individual hemostatic parameters differed significantly between the treatment groups. Likewise, no significant nor clinically relevant differences in the effects of both treatments on the volunteers’ lipid profiles were detected. The data on carbohydrate variables suggested a slightly more favorable influence of the 23-day 20/75 regimen. The increase of the glucose AUCs after three cycles tended to be stronger with the 21-day 30/75 regimen than with the 23-day 20/75 regimen. In addition, the AUCs for insulin and C-peptide were slightly reduced after three cycles with the 23-day 20/75 regimen but slightly increased with the 21-day 30/75 regimen. Both study treatments were safe and well tolerated by the volunteers as shown by the nature and frequency of adverse events, the routine laboratory examinations, and the physical and gynecological examinations. Both preparations provided adequate contraceptive reliability. The only pregnancy during treatment was attributable to intake errors. In conclusion, the prolongation of the treatment phase of an oral contraceptives with 20 μg ethinyl estradiol does not evoke more pronounced metabolic effects than a conventional 21-day regimen with 30 μg ethinyl estradiol.

This prospective, double-blind, randomized study was conducted to compare the contraceptive reliability, cycle control, and tolerability of a 23-day versus a 21-day oral contraceptive regimen containing 20 microg ethinyl estradiol and 75 microg gestodene. Participants took trial medication daily for 28 days, either 23 tablets with active substances plus 5 placebo tablets or 21 tablets with active substances plus 7 placebo tablets. Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of seven cycles. Efficacy data gathered from 4,878 treatment cycles (23-day regimen: 2,362 cycles; 21-day regimen: 2,516 cycles) were obtained from 703 participants (23-day regimen, n = 342; 21-day regimen, n = 361). Both preparations proved to be effective contraceptives and provided good cycle control. One pregnancy because of method failure was recorded in each treatment group. This resulted in a study Pearl Index of 0.5 for each treatment. For the 23-day regimen, 36.0% of participants reported at least one intracyclic bleeding episode during Cycles 2-4 (primary target) compared to 37.1% in the 21-day regimen. In the 23-day regimen group, intracyclic bleeding episodes were reported by 42.4% of the participants in Cycle 1 but only in 14% in Cycle 7 and in the 21-day regimen group by 44.6% in Cycle 1 and only 17.3% in Cycle 7. Overall, intracyclic bleeding was reported in 21.9% of the 23-day regimen cycles and in 22.7% of the 21-day regimen cycles.A greater number of 23-day regimen participants had shorter withdrawal bleeding periods than with the 21-day regimen. In significantly (p0.0001) more cycles in the 23-day regimen group, participants reported withdrawal bleeding periods that lasted only 1-4 days compared to the 21-day regimen group. For the majority of the treatment cycles, the median number of bleeding days in the 23-day regimen group was 4 days and in the 21-day regimen group 5 days. Both preparations were well tolerated and showed a similar adverse events pattern. The discontinuation rate because of adverse events was low (23-day regimen, 6%; 21-day regimen, 4%). No serious vascular adverse events were reported. More than 75% of the women in both groups either lost more than 2 kg of weight or did not gain weight during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study.

A total of 2741 high-risk pregnant mothers underwent invasive prenatal procedures, and in 94 of them (3.4%), fetal chromosomal or genetic anomalies were detected. In this study, we report on single pericentric inversions of chromosome 9 as well as translocations, which constituted 32% (30 of 94) and 16% (15 of 94) of all identified chromosomal or genetic abnormalities, respectively. In six fetuses of the 30 with an inversion of chromosome 9, ultrasound findings were abnormal and consisted of hydramnios, anhydramnios, hydroureter, hydronephrosis, encephalocele and prune belly syndrome, occurring singly or in combination. Among the 15 fetuses with chromosomal translocations, five had sonographic abnormalities. In conclusion, we found detailed ultrasound survey of fetuses with either translocations or inversions of chromosome 9 to be an additional source of useful information concerning fetal status that could be of value in genetic counselling of affected parents.

Purpose: This study was initiated to determine the negative effect (cryodamage) on human spermatozoa after freeze–thawing and to find out whether freezing of spermatozoa with a computerized biological freezer is more advantageous than freezing above static liquid nitrogen vapour with regard to spermatozoa vitality, chromatin normality, morphology, and membrane integrity.

OBJECTIVES The intrauterine growth retardation (IUGR) contributes specially to perinatal mortality and morbidity. An effective treatment is not yet available. The purpose of this study is to analyse the perinatal data of a cohort with IUGR-infants including mortality and morbidity and to describe prematurity and IUGR as a combination of high risk. STUDY DESIGN We have analysed the perinatal data of a cohort of 220 patients with IUGR-infants including mortality and morbidity. Regularly we examined fetal ultrasonographic growth, doppler measurements of fetal and maternal vessels and CTG, as well as indicated amniocentesis, placentesis and cordocentesis. Entry criteria were: normal menstrual period before pregnancy, clear gestational age, complete history of pregnancy. RESULTS At the Department of Gynaecology & Obstetrics, University Hospital, Homburg/Saar, the incidence of IUGR (< 10th Percentile) in premature babies and newborns was 13.1% over five years (1993-1997). The percentage of premature babies with IUGR was 18.6%. The overall mortality was 4.1%, the perinatal mortality was 3.6% and the neonatal mortality was 2.7%. In 1.4% intrauterine foetal death was observed, all associated with a birthweight below the 3th percentile. The average duration of pregnancy was 34 + 4 weeks. A high perinatal mortality of 13.1% and an overall mortality of 14.7% was observed. 11.4% of the premature babies with IUGR showed deformities and about 2% presented chromosome aberrations. 46.4% of children have been transferred to the Neonatal Intensive Care Unit. 57.1% of the postnatal complications have been related to the lungs, 26.5% to the cardiovascular system and 14.3% to the cerebrum. Maternal complications were referred to: SIH/EPH-gestosis (65.4%), HELLP-syndrome (5.8%), nicotine abuse (31.4%), pregnancy anaemia (17.3%) and gestational diabetes with insuline therapy (7.7%). On the placental site the most noticeable conditions have been placental insufficiency (40.6%) and placental infarction (28.7%). CONCLUSION Children with IUGR are exposed to high perinatal mortality and postnatal morbidity. Premature babies in association with an IUGR are at high risk. The surveillance of the pregnant women and the new-born children should be performed in a perinatal centre.

OBJECTIVE: To determine the effect of hypertensive disorders in pregnancy on the neonatal outcome of growth restricted fetuses. There is conflicting data on the effect of hypertension during pregnancy on the incidence of neonatal respiratory distress syndrome (RDS) and intraventricular hemorrhage. Some studies report a lower incidence of RDS and intraventricular hemorrhage in infants of hypertensive mothers, whereas other studies report a similar or higher incidence in infants born to hypertensive mothers. STUDY DESIGN: We performed a retrospective analysis of 220 growth restricted fetuses born between January 1, 1996 to July 1, 1997 at the Department of Obstetrics and Gynecology of the University-Hospital at Homburg/Saar. Data were obtained by review of the medical records. Growth restricted infants born to preeclamptic women or women with HELLP syndrome were compared to growth restricted fetuses born to mothers without hypertensive disorders. RESULTS: Growth restricted fetuses born to hypertensive mothers had a significant lower birth weight (p < 0.05). The incidence of RDS in children born to hypertensive mothers was significantly higher (p < 0.05, p < 0.01) and they stayed significantly longer in the neonatal intensive care unit (p < 0.01). In contrast to infants born to mothers with HELLP syndrome (n = 7) there was no difference in the incidence of intraventricular hemorrhage, infection, sepsis, necrotizing enterocolitis or cardiac complications (arrhythmia, insufficiency) in case of preeclampsia (n = 68). The perinatal mortality of infants born to hypertensive mothers was significantly higher (p < 0.05, p < 0.01). CONCLUSION: This study does not support the contention that hypertensive disorders in pregnancy have a beneficial effect on the postnatal course of IUGR infants.

Objective: The article presents a retrospective analysis (1989–1997) of the prenatal diagnosis, the course and completion of pregnancy of 26 fetuses with omphalocele and 18 fetuses with gastroschisis. Subjects: 44 pregnancies with anterior fetal wall defect diagnosed by prenatal ultrasound, clinical or patho-anatomic examination between 1989 and 1997 at the Department of Obstetrics and Gynecology, University of Homburg/Saar. Results: In 40 of 44 pregnancies (91%) the fetal ventral abdominal wall defect could be detected antenatally with ultrasound. Associated malformations in fetuses with omphalocele were seen in 18 cases (69%), whereas only five fetuses with gastroschisis (28%) had an associated malformation. Nineteen of 26 fetuses (73%) with omphalocele had a normal karyotype. Seven of 26 fetuses (27%) with omphalocele had an abnormal karyotype. Eleven fetuses with omphalocele were live born, three of them with minor anomalies. Ten babies with omphalocele survived. No chromosomal anomalies were detected in fetuses with gastroschisis. There were four gastrointestinal malformations and one lethal associated malformation in fetuses with gastroschisis. There were 15 live born babies with gastroschisis, all of whom have survived. In 20 of 44 cases (45%) with ventral abdominal wall defect oligohydramnios could be detected by ultrasound. In 28 of 44 cases (64%) we found fetal growth retardation

Introduction: The efficiency of mammography screening in highly specialized diagnostic centres has been well proven for the age group 50-64 years. Few data is available concerning the value of such a screening under decentralised, population-wide conditions. Since 1992, a mammography screening program (LMSP) organised in this way is being offered in Luxembourg to the age group 50-64 years. Materials and methods: The early outcome indicators of this screening programme were evaluated retrospectively. The pathological characteristics of all the diagnosed breast cancers, their diagnosis and their therapy before (1989) and after (1993) the introduction of the mammography screening programme were compared and analysed. Results: The early outcome indicators of Luxembourg's mammography screening programme were just below the comparable values of other specialised centres. Since the introduction of this programme one notes a significant increase in the number of open breast biopsies in comparison to the period before the screening programme (p = 0.0001), with a highly significant increase in benign biospies (p=0.00001). The ratio cancer/all biopsies dropped non-significantly from 0.35 to 0.28 (p = 0.09). Atypical proliferative hyperplasias and in situ carcinomas increased significantly in number (p = 0.01) as did the number of early invasive cancers (p=0.0015). The lymph node status did not change significantly although there was an increase in node-negative tumours (p=0.11). The number of conservative surgical procedures increased significantly (p = 0.00001). In the age group analysis these changes were significant only in the age group 50-64 years (p=0.0002). All these changes were not only due to the evolution within the screening cohort, but also to the changes among the tumour patients diagnosed outside the screening programme. Conclusion: The early outcome indicators of this mammography screening prove a possible efficiency even under population-wide, non-specialised screening conditions. Nevertheless, studies over a longer period of time will be necessary to analyse the evolution of cancer-specific mortality.

The estrogenic effect of tamoxifen on vaginal and cervical epithelium in postmenopausal women with breast cancer is evaluated.The tamoxifen group consisted of 92 postmenopausal breast cancer patients, the control group I of 30 postmenopausal women with breast cancer receiving no endocrine therapy and the control group II of 40 postmenopausal women without primary breast cancer taking no hormones. We determined the maturation index and the incidence of endocervical cell hyperplasia and metaplasia in cervical and vaginal smears.The maturation index increased under tamoxifen within the first 24 months from 0.4011 before taking tamoxifen (n=56) to 0.6039 (n=138, P0.0001). The maturation index in the group treated with tamoxifen was statistically significantly higher (P0.0001) than in the control groups (control group I: 0.3975, P0.0001; control group II: 0.4102, P0.0001). Under therapy with tamoxifen endocervical cell hyperplasia (P=0.00156) and metaplasia (P=0.00123) appeared significantly more often.An apparent increase not only of the incidence of endocervical cell hyperplasia and metaplasia but also of the maturation of the vaginal epithelium caused by the estrogenic effect of tamoxifen could be demonstrated.

Fibromatosis of the breast is a very rare disease with an incidence of less than 0.2% of all tumours of the breast. Less than 100 cases have been reported so far. A case of fibromatosis of the breast occurring in a 58-year old woman is described in this report. The patient was admitted with a suspected diagnosis of a concealed breast tumour with retraction of the skin for more than 1 year. Mammography was inconspicuous whereas ultrasound revealed a suspicious structure. The histology showed a fibromatosis of the breast of the desmoid type with negative oestrogen and progesterone receptors. It is anticipated that fibromatosis of the breast will behave similiar to fibromatosis occurring at other sites; i.e. as a local aggressive lesion exhibiting a high incidence of local recurrence following incomplete excision. Metastases are not known. There is no indication of mastectomy for fibromatosis of the breast of the desmoid type with no multicentricity. Primary organ-preserving operative therapy should be the aim of all treatment because spontaneous involution and longterm healing were observed. There are no indications of reducing the risk of recidivation by adjuvant postoperative radiotherapy or chemotherapy, whereas many successful treatments by endocrine therapies are described.

Aim: the impact of massive obesity (Broca-lndex >130% and >100kg body weight) on pregnancy, delivery and puerperium were studied in 118 matched pairs. Methods: Match criteria were: age, parity and time of delivery. Results: Massively obese pregnant women were significantly more likely to have an multitude of adverse outcomes, including hypertension antedating pregnancy (p = 0.007; these patients were excluded from the obese group for statistical analysis), oedema, proteinuria, gestational hypertension (each p

Between 1989 and 1994 first trimester transcervical chorionic villus sampling was offered to 158 patients after proper counselling. The gestational age range was 9-12 weeks. The most important indication was advanced maternal age (75.4%). Adequate sampling after two, and a maximum of three attempts, was achieved in 98% and 99.3% of patients respectively. After the first year of the study karyotyping using the direct method alone was successful in 96% of cases. The success of karyotyping cultures was 98%. Excluding one false positive result the rate of fetal karyotypic abnormalities was 4.8%. 5 spontaneous abortions occurred (3.2%), all in patients of advanced maternal age. Moderate or severe vaginal bleeding occurred in 6.7% of the patients. There was no case of chorioamnionitis.

The aim of this study was the validation of the minimal Resistance Index (min RI) measured by colour Doppler sonography as parameter of tumour neoangiogenesis. 107 patients with clinically or radiologically diagnosed breast tumour with a sonographically detectable lump had preoperative measurements and analysis of blood flow in the tumour area and in the healthy parenchyma of both breasts. The min RI was compared with histology, menopausal status and age. In all 107 patients blood flow could be measured in the tumour area and in 98% of the bilaterally investigated quadrants. Irrespective of tumour status the mean min RI was lower in the tumour area (0.62) than in the other quadrants of the affected (RI = 0.65, p = 0.002) or contralateral breast (RI = 0.65, p = 0.0003). The mean min RI of benign tumours was 0.60 (+/- 0.11 SD) and of malignant tumours 0.64 (+/- 0.11 SD), this difference was not significant (p = 0.07). Irrespective of tumour status postmenopausal patients had a higher mean min RI than premenopausal patients. This was true for the tumour area (RI = 0.64 vs 0.60, p = 0.11) and also for the quadrants (RI = 0.68 vs 0.62, p = 0.0002). In postmenopausal women there was a statistically significant correlation with age (r = 0.58, p = 0.0001). We conclude that the min RI is of no diagnostic relevance for the classification of breast tumours as benign or malignant.

In a group of 45 patients who had been conventionally irradiated, a multivariate analysis of prognostic factors was performed to find criteria for patient selection for surgery and radiotherapy or radiotherapy only. Nine patients underwent resection of metastases before irradiation. In most cases 10 x 3 Gy over 2 weeks were administered. 28 patients received concomitant hormonal treatment. Complete remission was seen in 30% of the non-operated cases (partial remission 25%). Symptomatic relief was seen in 67% of all cases. Median survival was 4 months (9.5 months after surgery) (p = 0.02). Survival of patients having had simultaneous extracerebral metastases and low Karnofsky performance status was disappointing. All long-time survivors received either hormonal treatment or chemotherapy. Karnofsky performance status and interval between the diagnosis of the primary tumour and the development of brain metastases were the most important prognostic factors. The influence of age and extracerebral metastases was less pronounced. In case of favourable prognostic factors and solitary metastases surgical treatment should be considered. Primary irradiation seems to be appropriate for the majority of patients. In any case an additional hormonal or chemotherapy must be considered. It seems to be questionable if patients with poor Karnofsky performance status and extracerebral metastases should be irradiated.

Oestrogen receptors were demonstrated immunohistochemically in 120 breast cancer cases; in 90 cases, progesterone receptors were additionally assessed. Immunohistochemical staining was evaluated by the so-called «immuno-reactive score» and quantified densitometrically by a method of computer-assisted image analysis. The measuring method allowed an objective evaluation of the portion of receptor-positive cells, the mean optical density and the distribution pattern of receptor concentrations within receptor-positive nuclei. Image analysis was compared with the semiquantitative evaluation by IRS. In 29 out of 58 weakly stained sections, which were scored as receptor-negative, receptor-positive cells could be demonstrated by image analysis because of the definition of an objective cut-off level for specific staining. Furthermore, three different patterns of distribution of receptor concentration could be distinguished: Type 0: receptor-negative carcinomas Type 1: homogeneous receptor expression within receptor-positive cells Type 2: heterogeneous receptor expression with high receptor concentrations in single cells. Type 2 patterns were almost exclusively found in postmenopausal patients, a dependence of expression pattern from grading was not demonstrated. These distribution patterns were found in the same manner in the expression analysis of progesterone receptor. With immunohistochemical staining only 45% of ER-negative carcinomas expressed PR, but 74% of ER-positive carcinomas. When ER was expressed heterogeneously (Type 2) PR was expressed in the same way in 62 % of the cases. Beneath the exact determination of the portion of receptor-positive cells the analysis of the pattern of distribution is only possible by image analysis. These different distribution patterns of receptor expression are of interest not only for cellular biology but also as potentially important factors for clinical prognosis

In a prospective randomised study, the effects of an intracervical gel containing 0.5 mg PgE2 and an intravaginal tablet containing 3 mg PgE2 were compared in their efficiency to induce delivery at term. When only gel was used, induction failed in 45% of the cases, especially with an initially immature cervix score. However, these patients did show significant improvement of the Bishop score. The vaginal tablet was more effective with regard to the induction of delivery. When using the vaginal tablet alone, induction failed in only 5% of cases (p < 0.001). Best results, however, were obtained with a combination of both application forms. In this group there were no failures. Tablet application induced delivery within 24 hours in 56% of the cases, gel application in only 27% (p < 0.001). There were no significant differences observed in these groups during the course of labour. The length of the latency period was identical, whether a tablet or a gel was used in initiating labour. In 29% of the cases, beta-sympathicomimetics had to be used because of tetanic contractions or polysystolia. No significant differences in the occurrence of these contractions were seen in either the gel or the tablet group. Even in a high-risk collective with 25% pathological Doppler-flow findings, no higher rate of operative deliveries or fetal acidoses was observed after prostaglandin induction, if careful surveillance of the patients and early use of tocolytics in experienced hands were administered. Our results further confirm the concept of a differential induction of labour with prostaglandins.(ABSTRACT TRUNCATED AT 250 WORDS)

In a study group of 41 pregnant women of postpartally confirmed placental abruption, the prognostic value of clinical and diagnostic findings was investigated. The incidence of placental abruption was 1.4% of all deliveries within a three-year interval. 51% of patients showed vaginal bleeding before delivery. Retroplacental haematoma was found in 49% of cases ultrasonographically. A total of 75% had a pathological CTG test. More than 95% of these findings occurred within 3 days before delivery. Abnormal Doppler flow findings in foetal vessels more than 3 days before delivery were seen in 62% of cases. In the last three days before delivery, 86% were abnormal. Preterm delivery before 37 weeks of gestation was registered in 82% of patients. Perinatal mortality amounted to 12%. The rate of severely dystrophic newborn was 30%. Even in cases with lack of the clinical and/or sonographical findings, the possibility of placental abruption should be considered, if an acute deterioration of cardiotocographic or Doppler-sonographic findings.

To determine whether absence of end-diastolic flow in the umbilical artery and/or fetal aorta impacts postnatal neuro-development in preterm-born children. The study group, consisting of 43 fetuses with absent end-diastolic flow in the umbilical artery and/or fetal aorta, was compared with a control group, consisting of 30 fetuses, matching for gestational age but with normal doppler-flow results. The children’s neuro-developmental status was assessed using the ‘Munich functional developmental diagnostics’ (MFDD), between the 2nd and 3rd year of life. Gestational age at birth was 33 + 6 weeks in the study group and 34 + 4 weeks in the control group. A brain-sparing effect was observed in 37.3% of fetuses in the study group compared with 10.0% in the control group (p = 0.014). For all seven MFDD domains, the number of children with deficiencies was higher in the study group. For the domains perception, active speech and comprehension this effect was statistically significant (p

From 1970-1990, 159 patients with invasive malignant tumours of the vulva (150 squamous cell carcinomas) underwent surgery at the University Hospitals, department of gynaecology. Heidelberg (1970-1988) and Homburg/Saar (1988-1990). 73% of the patients were more than 60 years old and 3% were less than 40 years old. The mean age was 69 years. 30% of the patients had diabetes mellitus. As a standard therapy, 101 patients had radical vulvectomy with bilateral inguinal node removal in accordance with S. Way. If nodes were found to be positive, the inguinal/pelvic region was irradiated postsurgically with 40-50 Gy. The 5 years survival rate for all patients with vulvar carcinoma was 69%. For early stage carcinomas (pT1, depth of invasion 10 mm (p < 0.001), if stage was pT1 as opposed to pT2 to pT4 (p < 0.001) or if lymphangiosis carcinomatosa (p < 0.01) was present or not. Prognostic differences were also noticed, if cytological grading was done in accordance with Broders (p < 0.09). 27 patients had successful reconstructive surgery with local cutaneous or myocutaneous flaps at the time of initial surgery. The median recovery period after radical vulvectomy with bilateral inguinal lymph node excision was 22 days. The median recovery period after radical vulvectomy with bilateral node removal and reconstructive surgery was 25 days. Early recurrence of carcinoma (< or = 6 months after initial therapy) was 5.9%, late recurrence was 12%.

At the University Hospitals of Heidelberg (1970-1988) and Homburg/Saar (1988-1990), 182 patients with vulvar carcinoma were treated. 51 patients had a recurrence of vulvar carcinoma and 21 patients showed a persistence of this tumour. 19 women had a second recurrence of vulvar disease. In these cases, therapy ranged from local surgery to exenteration, depending on the site and tumour extension. 18 patients underwent successful reconstructive surgery. Prognosis was better in cases with local recurrence in comparison to distant sites of metastatic progression (i.e. inguinal nodes or disseminated disease) (p less than 0.001). The five-year survival (after diagnosis of recurrent disease) for patients with early onset of recurrence (less than 20 months after initial therapy) was 28% compared to 68% for patients with late onset of recurrent disease (p less than 0.01).

At present, there is an increasing discussion regarding the change of the prostacyclin/thromboxane ratio as an aetiological factor of pregnancy-induced hypertension (PIH). By means of videophotometric capillaroscopy in the capillaries of the nailfold, it is possible to visualise the resulting changes in the microcirculation. This method employs a special illumination microscope (magnification of the optical system x 560). Red blood cell velocity is measured under test conditions and microcirculatorical reaction capacity on ischaemic stress. Studies were conducted on healthy non-pregnant women and on healthy pregnant women as well as on patients suffering from pregnancy-induced hypertension. A markedly reduced velocity of red blood cells in patients with pregnancy-induced hypertension was seen as a sign of vasoconstriction, namely, 0.53 mm/sec. versus 0.74 mm/sec. Furthermore, these patients have a higher reactivity to ischaemic stress, probably also as a result of the already existing vasoconstriction; however, the duration of the hyperaemic phases is reduced in pregnancy-induced hypertension. By this method, an insight can be gained into microcirculation in pregnancy and in pregnancy-induced hypertension. In addition, as preliminary studies have already shown, the influence exercised by different medications on microcirculation can be assessed.

Reports about uterine rupture in pregnancy subsequent to previous laparoscopic surgery are not frequent. This may be due to the lack of long term follow up of patients who had undergone this surgery rather than the rarity of this complication. A case of uterine rupture subsequent to laparoscopic myomec- tomy is reported. An increasing rate of the occurrence of this complication is reviewed in current literature, thus reiterating the need for more stringent selection criteria for patients who benefit from this surgical technique.

To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia.A prospective, randomized, open-label study was conducted in nine centres in Canada. Healthy women over 30 years of age suffering from idiopathic menorrhagia were treated either with LNG-IUS (n = 20) or with OC1/20 (n = 19) over 12 months. The primary endpoint was the change in MBL from baseline to 12 months. Secondary endpoints included treatment success (defined as a MBL score100 after 12 months), hemoglobin levels, and the menorrhagia severity score.In both treatment groups, MBL decreased significantly from baseline to 12 months (P0.001). For the primary endpoint, the MBL score decreased significantly more in the LNG-IUS group (median from 228 to 13, mean percent change-83%) compared to the OC1/20 group (median from 290 to 72; mean percent change-68%) (P = 0.002) after 12 months. In the LNG-IUS group, 80% of subjects had treatment success compared with 36.8 % in the OC1/20 group (P0.009). Both treatments increased hemoglobin concentrations significantly between baseline and 12 months. The menorrhagia severity score was consistently lower in the LNG-IUS group at all study time points and was significantly lower (P = 0.045) at six months. Both treatments were well tolerated.Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20.

The endometrial carcinoma shows an increasing incidence and represents today the most frequent malignoma of the female pelvis. Until now all techniques of detection of this carcinoma or its precursors are invasive and thus are not suitable for screening investigations. Vaginosonography, as the first non-invasive diagnostic method, now supplies knowledge about the state of the endometrium. At the Gynaecological Department of the University of Homburg/Saar, West Germany, 221 patients had been preoperatively subjected to vaginosonography before they underwent surgery. Sonographical and histological findings corresponded in atrophic endometrium in 82%, in regular, perimenopausal endometrium in 91%, in endometrial polyps and hyperplasia of the endometrium in 56%, and in endometrial carcinoma in 79%. With regard to the detection of endometrial cancer, a specificity of 96%, a sensitivity of 93%, a positive predictive value of 79% and an accuracy of 96% were established. Thus, according to our experience, vaginosonography represents a valid, non-invasive diagnostical method as a suitable instrument for screening the endometrium.

Of 1950 pregnant patients (2870 Doppler ultrasound measurements) we observed, in a study group with highly abnormal Doppler-flow findings (n = 66, Feb. 1990), a correlation of Doppler flow and FHR-recordings. Among these 66 patients we retained 60 (91%) in the hospital. They had at least 2 FHR-recordings a day. The results of Doppler flow measurements in the fetal aorta and umbilical artery correlated well with diagnosis of IUGR. The comparison of the overall results of both fetal vessels did not indicate any significant difference. In 21% of all patients with highly abnormal Doppler flow findings, was no abnormal FHR record until delivery. 26% already showed an abnormal non-stress test before the first pathological Doppler assessment, in 44% abnormal FHR-recordings were observed later than the first abnormal Doppler flow finding in the course of pregnancy. The median interval was 13.5 days in cases with increased Doppler flow parameters but with detectable end-diastolic blood flow and was reduced to 8 days in cases with absent end-diastolic blood flow. In 9% of all cases, abnormal results were found with both methods on the same day. In 32% we observed a reproducible notch in Doppler flow velocimetry of uteroplacental vessels. The rate of congenital malformations was 14%. Thus abnormal Doppler flow signals can be estimated as "early" prognostic criterias for a compromised fetus at risk.

160 woman patients in whom the course of pregnancy was uneventful or pathological (intrauterine growth retardation, percentile less than 5) were investigated at the Department of Obstetrics and Gynaecology of the University of Homburg/Saar between the 28th and 42nd week of pregnancy, using a newly developed cardiotocograph (HP M1350A Hewlett-Packard, Boblingen, FRG). By means of the kinetocardiotocogram (KCTG), fetal mobility (fetal movements of the whole body or of the extremities) was recorded simultaneously with the conventional recording of the fetal heart rate and uterine contractions. One of the aims in developing the KCTG was to record as far as possible all fetal movements synchronous to the recordings of heart rate and uterine contractions. To this end, the recording algorithm of the KCTG was adapted to the examination results obtained by two simultaneously operating ultrasound investigators. After the 28th week of pregnancy it was possible to record by the KCTG fetal "movement clusters" (combined body and limb movements) independent of the weight of the fetus and of amniotic fluid volume or positional anomalies, reliably and with good correlation with the results of the sonographic control investigations (r = 0.88-0.97). In cases of intrauterine growth retardation (percentile less than 5) a significantly reduced motility was observed on average as early as 13 days before delivery (p less than 0.005). It must be emphasized that, at this stage, most of the antenatal CTGs were normal. These findings indicate that KCTG can contribute to improved monitoring in high-risk pregnancies.

This study describes a comparison between two different ultrasound methods used to localize a low-lying placenta or a placenta previa. The methods implemented were the abdominal ultrasound and the so-called "perineal scan", an ultrasound examination of the female urogenital tract, which is performed by using the perineum as an acoustic window. Between 1985 and 1988, 84 patients, suspected of having a low-lying placenta, were examined by perineal scanning. In all these cases it was possible to compare the results with those of abdominal ultrasound examinations documented in the patient's records. The "perineal scan"-examinations were performed "blind", i.e., without knowledge of the results of prior abdominal ultrasound. Abdominal sonography was performed by a different examiner using the full-bladder-technique. Perineal scanning was done a short time after voiding. The results showed considerable and significant (p less than 0.001) discrepancies between the two methods; perineal scanning more often demonstrated higher grade diagnoses (27 patients, 32%) than vice versa (9 patients, 11%). These differences may be at least partially explained by the influence of bladder distension. Probably a full bladder produces false negative results more often than previously suspected. An analysis of pregnancy outcome yielded positive predictive values of 78% (abdominal ultrasound) and 86% (perineal scanning). Perineal scanning therefore seems to provide an uncomplicated and reliable means to verify an abdominal placenta localisation.

In 50 cases with an end-diastolic zero flow or reverse flow all antenatal and perinatal abnormalities have been recorded. The fetal outcome was registered. The percentage of highly dystrophic newborns (percentile less than 5) was 88%. The perinatal mortality counted up to 16% and the percentage of congenital malformations (including chromosomal anomalies) was 12%. A reverse flow was registered in 4 cases. The perinatal mortality of those cases with reverse flow was 100%. In approx. one-quarter of those pregnancies and in 50% of the perinatally deceased newborns, there were no pathological or suspicious changes in the antepartal and/or subpartal CTG-recordings. The Duplex sonographical diagnosis of an end-diastolic zero flow/reverse flow, has a highly positive predictive value, whereas its sensitivity is low. It can be regarded as a very helpful parameter in clinical diagnosis, particularly as it is independent of borderline values. The correct choice of the high-pass wall filter (50-100 Hz) is important.

7000 pregnancies were analysed after genetic amniocentesis in respect of the further course and results of prenatal diagnosis (observation period 1975-1988). In 3.1% (217 cases) samples of amniotic fluid were discoloured. Vaginal haemorrhages prior to amniocentesis were recorded with significantly higher incidence (18%) in patients with discoloured amniotic fluid than in a control group (n = 217) with normal colour of the amniotic fluid (4.6%) (p less than 0.001). Miscarriages and chromosome anomalies occurred more often in the study group (3.7%/2.8%, control group: 0.9%/1.8%, n.s.). The risk of miscarriages was increased in cases with sanguineous amniotic fluid if the amniotic fluid alpha-fetoprotein values were enhanced at the same time. Significant differences were observed in respect of the incidence of foetal malformations in patients with discoloured amniotic fluid (7.8%) and in the control group (2.3%) (p less than 0.01). Borderline or definitely pathological amniotic fluid AFP concentrations were found often if the amniotic fluid was discoloured (6.9%, control group 3.2%). If discoloured amniotic fluid was sampled, foetal malformations should be excluded sonographically. In 82% of all cases with discoloured amniotic fluid and foetal malformations pathological sonographic findings and/or enhanced MS-AFP values were recorded even prior to amniocentesis.