17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial

Background âwomen with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or 17P) to placebo has been published, and this trial was stopped early due to a large treatment benefit. Objective âThis study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation. Study Design âThis was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB (clinicaltrials.gov: NCT 01004029). Women were enrolled at 93 clinical centers (41 in the United States and 52 outside the United States) between 16 0/7 to 20 6/7 weeks in a 2:1 ratio, to receive either weekly intramuscular (IM) injections of 250 mg of 17-OHPC or an inert oil placebo; treatment was continued until delivery or 36 weeks. Co-primary outcomes were PTB < 35 weeks and a neonatal morbidity composite index. The composite included any of the following: Neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, or proven sepsis. A planned sample size of 1,707 patients was estimated to provide 98% power to detect a 30% reduction in PTB < 35 weeks (30% to 21%) and 90% power to detect a 35% reduction in neonatal composite index (17%-11%) using a two-sided type-I error of 5%. Finally, this sample size would also provide 82.8% power to rule out a doubling in the risk of fetal/early infant death assuming a 4% fetal/early infant death rate. Analysis was performed according to the intention-to-treat principle. Results âaseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71-1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68-1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4-1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States (n = 391; 23% of all patients), although the rate of PTB < 35 weeks was higher than the overall study population, there were no statistically significant differences between groups (15.6% vs. 17.6%; relative risk = 0.88 [95% CI: 0.55, 1.40]. Conclusion âin this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death

STATUS OF HEMOLYMPHOCIRKULATION DURING EXACERBATION OF CHRONIC INFLAMMATORY OF WOMEN SMALL PELVIC ORGANS AND DUKING OF THEIR CORRECTION

Purpose: it was concluded in revealing the particularities hemolymphocirculation in pool of the small pelvic at exacerbation of the chronic inflammation beside woman's and study efficiency to their correction with use lymphogenic technology. Define clinical and morphological criteria of scar after caesarean section to form the groups pregnant for the following vaginal labor. Methodology: prospective study. Subjects: 314 women with chronic pelvic inflammatory disease in stage of the intensification. Methods: reolymphovasography for quantitative and qualitative estimation of the factors lymphodinamic on 1, 5 and 7 day of the treatment. Teplovizion study by means of teplovizor IFP-M in mode of the real time. The range of the temperature 25-41оС, limiting sensitivity of the instrument not less 0,1оС. The scene of the heat relief registered in projections pelvic organ in hypogastric`s area. Results: Under chronic inflammation organ small basin in stage of the intensification occurred the reduction of the arterial influx in region of the small basin in 2-6 once, increase venous and lymphatic current in 1,5-3 times, increasing of the kinetic resistance in arterial riverbed and reduction in venous-lymphatic section, as well as reduction in 1,3-3,5 times. Herewith time of the filling microcirculation and venous riverbed. Use lymphogenic technology in correction of the chronic pelvic inflammatory disease brought about increase the arterial influx in small basin on 23%, time of the microcirculatory and venous division on 36%, initial and final velocity of the influx in 1,4 times, velocities and volume venous and lymphatic filling on 13-14%. When change the cofrom-carryings arterial, venous and lymphatic section approached to factor beside «practically normal» women. The offered diagnostic criteria degrees to insufficiency hemolymphocirculation in pool of the small basin under chronic inflammation in stage of the intensification beside women, as new on given reolymphovasography and remote teplovizion studies have allowed to value the condition an hemolymphocirculation in region. Conclusion: Marketed in persisting work approach to treatment of the chronic pelvic inflammatory diseases with use of lymphogenic technology has shown pathogenetic directivity of the applying methods and, as effect, this high clinical efficiency, and as a result of reduction inflammatory process when recovering hemolymphocirculation in region of the small pelvic. The method of reolymphovasography for op-remissions of the breaches hemolymphocirculation in pool of the small basin is criterion to efficiency treatments chronic pelvic inflammatory diseas

RISK FACTORS AND CYTOMORPHOLOGICAL CHARACTERISTICS OF THE CHORION IN THE GENESIS OF SPONTANEOUS ABORTION IN FIRST TRIMESTER

Cytomorphological features of the chorion and risk factors for spontaneous abortion in the first trimester are studied. A total of 98 pregnant women were divided into 2 groups: the 1st (main) group - 38 pregnant women with spontaneous abortion in 1 trimester (38.78%), 2nd (control) group - 60 pregnant women with induced abortion 1 trimester (61,22%). One of the major risk factors for spontaneous abortion was a chronic persistent viral infection: expression of the investigated agents (Herpes simplex virus types 1 and 2, Cytomegalovirus, a virus Epstein-Barr), reached 84.2% and 88.33%, which, in the absence of inflammatory manifestations in the tissues of the chorion, reflected a significant infection of women and, probably, their predisposition to miscarriage. The results of serological investigations of studied agents not always indicated the infection of chorionic structures with these pathogens. Chronic viral infections had persistent subclinical character. Therefore the great importance in predicting of their effects on pregnancy had evaluation of the percentage of leukocytes, leukocyte index of intoxication and platelets. The most significant anamnestic risk factor for spontaneous abortion was spontaneous termination of previous pregnancies. Morphological changes in the structures of the chorion in spontaneous abortion in first trimester were heterogeneous, but most were caused by infectious disorders caused by pathogens TORCH-complex (70%). In determining the localization of pathogens chorionic tissues revealed expression of the most frequently studied pathogens in the trophoblastic epithelium and stromal cells of the villi, indicating on penetration of pathogens in the placenta