Assessment of tibolone effects on menopausal symptoms and cardiovascular markers

To assess Tibolone effects on menopausal symptoms, lipid profile, serum homocysteine levels, and C-reactive protein. Fifty two healthy post menopausal women, who had been menopausal for at least one year, were recruited in this prospective randomized controlled clinical trial. They were randomly assigned into two groups. The first group received 2.5mg Tibolone tablet [Livial] for 6 month was referred to as "Tibolone group'. The second group received placebo treatment for 6 month and was referred to as "Control group. Menopausal symptoms were assessed upon enrollment and after 6 months using the Greene climacteric scale. All women had an assay of total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, CRP, and serum homocysteine levels upon enrollment and after 6 months. After 6 months, Tibolone reduced significantly the Greene climacteric scale [median score=10, with score range=2-25] compared to the control group [median score=15, with score range=4-48. p=0.0013]. In the Tibolone group, there was significant decrease in the scale after 6 months compared to baseline. After 6 months, there was no significant difference between the 2 groups regarding the cholesterol, triglycerides, and LDL cholesterol levels. However, there was significant drop in the HDL cholesterol in the Tibolone group compared to the control group [63.33 +/- 15.41 Vs 75.80 +/- 21.11, p=0.016]. By applying the paired t-test and comparing the lipid profile values in the Tibolone group, there was a significant reduction in total cholesterol, triglyceride, and HDL levels after 6 months. There was no significant reduction in LDL cholesterol level. At baseline, there was no significant difference in the homocysteine level between the 2 groups. After 6 months, there was still no significant difference between the 2 groups. Within the Tibolone group, there was a 5.1% reduction in the serum Homocysteine level after 6 months compared to baseline, however, this was also non significant. After 6 months, CRP was significantly higher in the tibolone group compared to the control group [1.99 +/- 0.73 Vs 1.52 +/- 0.76, p<0.05]. Within the tibolone group there was significant rise in CRP level after 6 months. Tibolone is effective in controlling menopausal symptoms. Tibolone had favorable effect on total cholesterol and triglyceride levels, however, it reduced HDL. Tibolone had no effect on homocysteine levels, It was associated with a rise in CRP levels. Further long term clinical trials are needed to verify the cardiovascular effects of tiblone

Predicting preterm delivery in asymptomatic pregnant women with prior preterm delivery by measurement of cervical length, fetal fibronectin and phosphorylated insulin-like growth factor-binding protein-1

To evaluate the accuracy of cervical length measurement in combination with assessment of fetal fibronectin [FFN] and phosphorylated insulin-like growth factor-binding protein-1 [phIGFBP-1] in cervico-vaginal secretions as a predictor of preterm delivery in asymptomatic pregnant women with a history of preterm birth. 91 singleton pregnant mothers [between 22-24 weeks of gestation] with previous history of one or more unexplained preterm birth were included in the study. For all participants transvaginal sonographic measurement of cervical length was carried out together with qualitative assay of fetal fibronectin and quantitative measurement of phosphorylated insulin-like growth factor binding protein-1 in cervico-vaginal secretions. The primary outcome of the study was delivery before completed 37 weeks of gestation. There was a significant association between cervical length and the occurrence of preterm delivery [p=0.002], cervical length was 23.12 +/- 8.5mm in 33 cases who experienced preterm delivery compared to 29.34 +/- 9.4mm in 58 cases who delivered at term. Regarding fetal fibronectin assay in cervico-vaginal secretions, no statistically significant difference was found between those who delivered preterm and those who had term delivery [p=0.972]. Measurement of phosphorylated insulin-like growth factor-binding protein-1 [phIGFBP-1] in cervico-vaginal secretions showed statistically significant difference among patients who delivered preterm compared to those who did not [p=0.007]. Sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were calculated for cervical length, phIGFBP-1, and for their combination, and our results demonstrated high sensitivity, specificity, positive and negative predictive values for the combined method compared with either method alone. Both cervical length and phIGFBP-1 measurement in cervico-vaginal secretions at 22-24 weeks are likely to be useful in predicting preterm delivery in asymptomatic women with a history of preterm birth and their combination increased their sensitivity, specificity, positive and negative predictive values as predictors

Foley's catheter plus prostaglandin E[2] compared to prostaglandin E[2] alone for induction of labor

To compare the effectiveness of Foley catheter plus prostaglandin E[2] tablets with prostaglandin E[2] tablets alone in cervical ripening and induction of labor. Patients admitted for induction of labor were randomized into 2 groups. Group A received PGE[2] tablets and intracervical Foley catheter. Group B received PGE[2] tablets only. PG tablets were given to a maximum of 2 doses 6 hours apart. All patients had Bishop Score of <5 and no contraindication to vaginal delivery. After 12 hours, Bishop Score was assessed. Patients with favorable cervix [Bishop >/= 7] had artificial rupture of membranes. Syntocinon was started if there are no adequate uterine contractions. 300 patients participated in the study; 150 in each group. Bishop Score after 12hrs was significantly higher in group A compared to group B [7.48 +/- 1.72 Vs 6.09 +/- 1.85, p<0.01] as well as the mean change after 12 hours [3.20 +/- 1.59 Vs 2.37 +/- 1.42, p<0.01]. 14.4% of patients in group A had a Bishop Score of <7 after 12 hours compared to 25% in group B [p<0.05]. The induction to delivery time was significantly less in group A compared to group B [16.81 +/- 3.29 Vs 18.04 +/- 3.53,p<0.01]. Syntocinon was used in 68% of patients of group A compared to 81% of patients of group B [p<0.05]. 74% of group A patients delivered vaginally compared to 70.6% in group B, the difference was insignificant. There was no statistically significant difference regarding the number of C.S. and the number of instrumental deliveries as well. There was no significant difference regarding the incidence of fetal distress, puerperal pyrexia, or uterine hyperstimulation between the 2 groups. The combination of prostaglandin and Foley catheter resulted in better Bishop Score, shorter induction to delivery time, and fewer failed inductions. However, there was no significant effect on vaginal delivery or C.S. rates

Evaluation of clinical findings and chlamydia antibody titre as predictors of tubal factor infertility

To compare the predictive capacity of clinical scoring system and chlamydia antibody titre in predicting tubal disease. This study included 70 infertile women with normal ovarian and male factors. All women had detailed history taking, general examination, local examination, and vaginal and cervical swabs for culture and sensitivity. A clinical scoring system based on the following variables was used for prediction of tubal disease; age, infertility duration, previous abortion, previous delivery, dysmenorrheal, dyspareunia, evidence of bacterial vaginosis, and tender adnexa. IgG Chlamydia antibody titre [CAT] and mid luteal phase serum progesterone were assessed using enzyme immunoassay [ELISA] technique. Tubal abnormality was assessed by hysterosalpingography [HSG] in the follicular phase. The clinical scoring and the CAT were compared by calculating the sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio [+LR], negative likelihood ratio [-LR], the relative risk [RR], and the area under the curve [AUC] of the receiver operator curve. CAT was positive in 20 patients [28.57%] out of the 70 studied women. Evidence of tubal disease identified by HSG was present in 34 patients [48.6%]. Sercopositive women had significantly higher incidence of tubal abnormality compared to seronegative women [p=0.0001]. The CAT was significantly higher in women with tubal disease [11.63 +/- 7.27] compared to women with normal tubes [6.76 +/- 4.02] [z=3.126, p=0.002]. The FAT achieved a low sensitivity of 50% and a high specificity of 91.67%. In comparison, the clinical scoring system achieved a balanced sensitivity and specificity of 82.35% and 86.11% respectively. The AUC of the clinical scoring system [0.89] was found to be significantly higher than that of the CAT [0.717]. The clinical scoring system proved to be more accurate than the CAT in predicting tubal disease