Background
Human cytomegalovirus (HCMV) is the leading infectious cause of congenital disabilities. We designed a prospective study to investigate the rate, outcome and risk factors of congenital cytomegalovirus infection (cCMV) in neonates born to immune women, and the potential need and effectiveness of hygiene recommendations in this population.
Methods
The study (NCT03973359) was composed of 2 sequential parts: an epidemiology (Part 1) and a prevention (Part 2) study. Performance of Part 2 depended upon a cCMV rate > 0.4%. Women enrolled in Part 1 did not receive hygiene recommendations. Newborns were screened by HCMV DNA testing in saliva and cCMV was confirmed by urine testing.
Results
Saliva swabs were positive for HCMV DNA in 45/9661 newborns and cCMV was confirmed in 18 cases. The rate of cCMV was 0.19% (95% CI: 0.11-0.29%), and three out of 18 infants with cCMV had symptoms of CMV at birth. Age, nationality, occupation and contact with children were similar between mothers of infected and non-infected newborns. Twin pregnancy (OR: 7.2; 95% CI 1.7-32.2; p = 0.037) and maternal medical conditions (OR: 3.9; 95% CI: 1.5-10.1; p = 0.003) appeared associated with cCMV. Given the rate of cCMV lower than expected, the prevention part of the study was cancelled.
Conclusion
Newborns from women with preconception immunity have a low rate of cCMV, which appears to be mostly due to reactivation of the latent virus. Therefore, serological screening in childbearing age would be pivotal to identify HCMV-seropositive women, whose newborns have a low risk of cCMV.
HighlightsLevonorgestrel IUD was effective in treatment of recurrent APA.No side effects were reported.No impairments on a subsequent pregnancy were reported.
The management of endometriosis-related infertility is still a challenging issue. Women can be managed with either surgery or in vitro fertilization (IVF). The decision is tailored to the patients considering pros and cons of both approaches. Surgery might increase the chances of natural conception and relieve symptoms. IVF may be more effective, but costs are higher and unoperated women face some peculiar additional risks during the procedure and pregnancy. The unavailability of randomized trials comparing the two strategies hampers the possibility to provide precise estimates. This Randomized Controlled Trial (RCT) aims at filling this gap. This is a multicenter, non-blinded, randomized controlled trial with parallel groups and allocation 1:1. Three Italian Academic Infertility Units will be involved. Main inclusion criteria are infertility for more than one year, age less than 40 years and a sonographic diagnosis of endometriosis (ovarian endometriomas or deep peritoneal lesions). Previous IVF and previous surgery for endometriosis are exclusion criteria. Women will be randomized to either surgery and then natural pregnancy seeking or a standard program of three IVF cycles. The primary aim is the comparison of live birth rate between the two groups (IVF versus surgery) within one year of randomization. The secondary aim is the evaluation of cost-effective profile of the two interventions. The present study can influence the clinical practice of infertility treatment in women with endometriosis. From a public health perspective, information on the more cost-effective clinical management strategy would consent a wiser allocation of resources.
Trial registration: NCT04743167, registered on 8 February 2021.
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