Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding.

INTRODUCTION: Second-trimester vaginal bleeding increases the risk of spontaneous preterm birth. We aimed to examine the efficacy of vaginal progesterone to reduce preterm birth rate in women with second-trimester vaginal bleeding. MATERIAL AND METHODS: Two-center, double-blind, placebo-controlled trial involving pregnant women with second-trimester vaginal bleeding. Women with documented uterine bleeding were randomly assigned in a 1:1 ratio to receive 200 mg of micronized vaginal progesterone or placebo once daily at 16-26 weeks until 36 weeks of gestation. Women who had prior preterm birth or short cervix diagnosed before recruitment were not eligible. The primary outcome was spontaneous delivery <37 weeks. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01269450. RESULTS: Between March 2011 and January 2017, 128 women gave consent and were randomized; 16 withdrew consent and 3 had a second-trimester termination of pregnancy. The final analysis included 109 women: 60 in the progesterone group and 49 in the placebo group. Demographic and obstetric characteristics did not differ between the groups. Primary outcome occurred in 19 (31.7%) and 12 (24.5%) in the progesterone and placebo groups, respectively (odds ratio [OR] 1.32; 95% confidence interval [CI] 0.55-3.16; P = 0.53). The proportion of births <34 weeks was similar between the groups (OR 1.19; 95% CI 0.47-3.02; P = 0.72), as were the survival curves from randomization to delivery (hazard ratio, 1.24; 95% CI, 0.60-2.56; P = 0.57). There were no significant differences in neonatal morbidities between the groups. The study was ended prematurely because of slow recruitment. CONCLUSIONS: Antepartum vaginal progesterone does not seem to reduce the incidence of preterm birth in women with second-trimester bleeding.

Screening Arab Israeli Pregnant Women for Group B Streptococcus by the AmpliVue GBS Assay: Are the Rates Higher than the National Average?

BACKGROUND: The recommendation of the U.S. Centers for Disease Control and Prevention regarding universal screening for Group B Streptococcus (GBS) at 35-37 weeks gestational age in pregnancy is not accepted in Israel. The National Council for Obstetrics, Neonatology and Genetics recommends intrapartum prophylaxis, mainly based on risk factors, to prevent early neonatal GBS infection. This policy is based on past studies demonstrating low colonization rates of the bacteria in Israeli pregnant women and very low neonatal sepsis rates. OBJECTIVES: To determine the applicability of the high-risk group prophylaxis policy for Arab Israeli pregnant women. METHODS: Vaginorectal swabs from Arab Israeli pregnant women who attended the labor ward between October 2015 and February 2016, were obtained before any pelvic examination for GBS identification using Quidel's AmpliVue® GBS assay. Women who tested positive received intrapartum antibiotic prophylaxis to prevent neonatal infection. Obstetric data were collected from each woman from a standardized questionnaire. Data regarding the delivery and neonates were collected as well. RESULTS: The study comprised 188 Arab pregnant women who met the inclusion criteria and signed a consent form to participate in the study. Of these, 59 had positive tests, and a carriage rate of 31%. No neonatal colonization of GBS was found. CONCLUSIONS: The carrier rate in Arab pregnant women in northern Israel is higher than the national average, at least partially due to the more sensitive method of GBS detection used in the present study.

Religion and family planning.

Religion is embedded in the culture of all societies. It influences matters of morality, ideology and decision making, which concern every human being at some point in their life. Although the different religions often lack a united view on matters such contraception and abortion, there is sometimes some dogmatic overlap when general religious principles are subject to the influence of local customs. Immigration and population flow add further complexities to societal views on reproductive issues. For example, present day Europe has recently faced a dramatic increase in refugee influx, which raises questions about the health care of immigrants and the effects of cultural and religious differences on reproductive health. Religious beliefs on family planning in, for example, Christianity, Judaism, Islam and Hinduism have grown from different backgrounds and perspectives. Understanding these differences may result in more culturally competent delivery of care by health care providers. This paper presents the teachings of the most widespread religions in Europe with regard to contraception and reproduction.

Tuberculosis during Pregnancy in Northern Israel, 2002-2012: Epidemiology and Clinical Practices.

BACKGROUND: Atypical presentation of tuberculosis (TB) during pregnancy may cause diagnostic delay and adversely influence pregnancy outcome. OBJECTIVES: To examine the incidence and clinical and epidemiological features of TB during pregnancy and investigate infection control measures at delivery and during the postpartum period. METHODS: We retrospectively evaluated all reported cases of TB diagnosed during pregnancy to 6 months postpartum in Israel's Northern Health District (2002-2012). RESULTS: Active TB was detected in six patients; all were negative for human immunodeficiency virus (HIV). Two patients were diagnosed in the postpartum period, and four had pulmonary involvement. The average incidence during this period (3.9 per 100,000 pregnancies) was similar to that in the general population. Five patients were at high risk of contracting TB due to either recent immigration from a high-burden country or being in contact with another individual with active TB. Patients with pleuropulmonary involvement had prolonged cough and abnormal chest X-rays, without fever. Diagnosis was delayed for 3 to 7 months from symptom onset. Investigation of the newborn to rule out intrauterine infection was conducted in only one of four relevant cases. All patients were infected with organisms susceptible to all first-line drugs, and all were cured with standard therapy. CONCLUSIONS: There was a considerable delay in the diagnosis of TB among pregnant women, and investigation of the newborn upon delivery to rule out TB infection was routinely omitted. Effective management of TB during pregnancy and the postpartum period requires a multidisciplinary approach including an obstetrician, pediatrician, TB specialist, and public health physician.

The petrous portion of the temporal bone as shown on sonography between 14 and 40 weeks' gestation.

OBJECTIVES: The purpose of this study was to examine the feasibility of sonographically identifying, measuring, and constructing nomograms of the fetal petrous bone, the part of the temporal bone that houses the auditory apparatus. METHODS: A total of 248 consecutive pregnant women between 14 and 40 weeks' gestation were included. During a routine scan using transvaginal or transabdominal sonography, the fetal head was assessed in transverse sections. First, the parotid gland or external ear was identified, followed by the petrous bone. This annular echogenic structure, located medially and superior to the parotid gland or external ear, was measured at its largest anteroposterior diameter. The petrous bone on at least one side was measured; if both sides were visualized easily, both petrous bones were measured. RESULTS: In 247 fetuses, at least one petrous bone was measured. The petrous bone measurement correlated well with the gestational age (R = 0.908; P < .001), biparietal diameter (R = 0.983; P < .001), and femur length (R = 0.913; P < .001). CONCLUSIONS: Depiction of the petrous bone is feasible at all gestational ages and correlates well with the gestational age, biparietal diameter, and femur length. The usefulness of the ability to depict this bone in prenatal diagnosis of congenital malformations of the inner ear should be tested in prospective studies.

Efficacy of Birth Dose Vaccination in Preventing Mother-to-Child Transmission of Hepatitis B: A Randomized Controlled Trial Comparing Engerix-B and Sci-B-Vac.

Background and aims: Peripartum transmission of hepatitis B virus (HBV) from an infected mother to the child can be prevented in most but not all cases by immediate vaccination of the newborn. The aim of this study was to compare the efficacy of two licensed hepatitis B vaccines, Engerix-B versus Sci-B-Vac, in preventing peripartum HBV transmission. Methods: A prospective multicenter randomized controlled study in 4 delivery centers was performed from 2009 to 2014. HBsAg positive pregnant women and their newborns were recruited at the delivery rooms. All newborns received Hepatitis B Immune Globulin within 10 h after birth, as well as active HBV vaccination at 0, 1 and 6 months of age. Maternal assessment at delivery included transaminases, blood count, international normalized ratio and viral status. Infants were tested for HBsAg, anti-HBc and anti-HBs at 12 months of age. Results: In the intention to treat (ITT), 171 infant and mother pairs fulfilled the study enrollment criteria and completed follow up, 82 received Engerix-B and 89 Sci-B-Vac. Maternal parameters and viral status were similar in both groups. At 12 months of age, the Sci-B-Vac group had lower HBsAg carriage rates (1/89, 1.1%) than the Engerix-B group (5/82, 6.1%) with borderline significance (risk difference of -0.05, 95% CI -0.11-0.007, t-test = 0.05), and borderline significance lower vaccine failure rates with anti-HBs < 10 mIU/mL in the Sci-B-Vac (2/89, 2.2%) than in the Engerix-B (8/82, 9.8%, p = 0.05). Higher seroprotection rates were found in the Sci-B-Vac group with all anti-HBs titer stratifications of >10 mIU/mL (p = 0.05), >100 mIU/mL (p = 0.05) and >1000 mIU/mL (p = 0.01). Active/passive vaccination was effective in 10/13 cases with maternal HBV DNA levels > 7 log10 IU/mL up to 9.5 log10 IU/mL, but failed in 3 cases for unknown reasons. Conclusion: Sci-B-Vac was superior to Engerix-B in preventing peripartum HBV transmission in neonates from HBsAg+ mothers and induces significantly higher anti-HBs levels. NIH registration number: NCT01133184.

Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules.

We report on an artificially intelligent nanoarray based on molecularly modified gold nanoparticles and a random network of single-walled carbon nanotubes for noninvasive diagnosis and classification of a number of diseases from exhaled breath. The performance of this artificially intelligent nanoarray was clinically assessed on breath samples collected from 1404 subjects having one of 17 different disease conditions included in the study or having no evidence of any disease (healthy controls). Blind experiments showed that 86% accuracy could be achieved with the artificially intelligent nanoarray, allowing both detection and discrimination between the different disease conditions examined. Analysis of the artificially intelligent nanoarray also showed that each disease has its own unique breathprint, and that the presence of one disease would not screen out others. Cluster analysis showed a reasonable classification power of diseases from the same categories. The effect of confounding clinical and environmental factors on the performance of the nanoarray did not significantly alter the obtained results. The diagnosis and classification power of the nanoarray was also validated by an independent analytical technique, i.e., gas chromatography linked with mass spectrometry. This analysis found that 13 exhaled chemical species, called volatile organic compounds, are associated with certain diseases, and the composition of this assembly of volatile organic compounds differs from one disease to another. Overall, these findings could contribute to one of the most important criteria for successful health intervention in the modern era, viz. easy-to-use, inexpensive (affordable), and miniaturized tools that could also be used for personalized screening, diagnosis, and follow-up of a number of diseases, which can clearly be extended by further development.

Barriers to human papillomavirus vaccine acceptability in Israel.

Barriers to human papillomavirus (HPV) vaccine acceptability in Israel include Israel's relatively low incidence of cervical cancer; the religiously-based 80% circumcision rate in Israel, which is regarded as contributing to the lower incidence of HPV infection in the country; the fact that HPV vaccine provides immunity against only few virus types; the vaccine's high cost; and the perception that HPV transmission is associated with unacceptable sexual relations. A recent survey has demonstrated that, following media two campaigns, Israeli's level of awareness of the vaccine increased but the actual vaccination rate remained low, at approximately 10%. Survey findings also indicated that an enduring barrier to HPV vaccination is the vaccine's high cost. Recent research on a convenience sample of Israeli undergraduate women 21 to 24 years of age showed that intentions to receive HPV vaccination in the coming year were a function of women's attitudes towards getting vaccinated and their perceptions of social support for doing so. Undergraduate women who intended to be vaccinated perceived the prevention of cervical cancer, avoidance of personal health threat, and avoidance of HPV infection per se to be the advantages of undergoing HPV vaccination. Disadvantages of getting vaccinated included fear of vaccine side effects, cost of the vaccine, and newness of the vaccine, doubts about vaccines, time required to undergo multiple vaccinations, and dislike of injections. Friends', mothers' and physicians' recommendations influenced women's intentions to be vaccinated in the coming year as well. This article forms part of a regional report entitled "Comprehensive Control of HPV Infections and Related Diseases in Israel" Vaccine Volume 31, Supplement 8, 2013. Updates of the progress in the field are presented in a separate monograph entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012.