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Background/objectives: The PREMEDI study was designed to assess the efficacy of nutritional counseling aimed at promoting Mediterranean Diet (MD) during pregnancy on the incidence of overweight or obesity at 24 months in the offspring., Methods: PREMEDI was a parallel-arm randomized-controlled trial. 104 women in their first trimester of pregnancy were randomly assigned in a 1:1 ratio to standard obstetrical and gynecological care alone (CT) or with nutritional counseling promoting MD. Women enrolled in the MD arm were provided with 3 sessions of nutritional counseling (one session per trimester). The main outcome was the proportion of overweight or obesity among the offspring at the age of 24 months. Maternal MD-adherence and weight gain during pregnancy were also evaluated. Lastly, the evaluation of epigenetic modulation of metabolic pathways in the offspring was analyzed in cord blood., Results: Five women in the MD arm and 2 in the CT arm were lost to follow-up, so a total of 97 completed the study. At 24 months, children of MD mothers were less likely to have overweight or obesity than those of the CT mothers (6% vs. 30%, absolute risk difference = -24%, 95% CI -38% to -9%, p = 0.003, number needed to treat 4, 95% CI 2 to 12, per-protocol analysis). A significantly higher increase of MD-adherence during the trial was observed in the MD arm compared to the CT arm. A similar body weight gain at the end of pregnancy was observed in the two arms. The mean (SD) methylation rate of the leptin gene in cord blood was 30.4 (1.02) % and 16.9 (2.99) % in the MD and CT mothers, respectively (p < 0.0001)., Conclusions: MD during pregnancy could be an effective strategy for preventing pediatric overweight or obesity at 24 months. This effect involves, at least in part, an epigenetic modification of leptin expression., Competing Interests: Competing interests The authors declare no competing interests. Ethics approval and consent to participate The trial was approved by the Ethics Committee of the University of Naples Federico II and was conducted in accordance with the Helsinki Declaration and relevant European and Italian privacy regulations. Written informed consent to participate in the study was obtained from the women and no financial compensation was provided. The trial was registered on ClinicalTrials.gov (Identifier: NCT03337802). The study took place at the Villa Betania Evangelical Hospital in Naples, Italy, between November 30, 2017 and January 31, 2021. The study is reported following the Consolidated Standards of Reporting Trials (CONSORT) guidelines., (© 2024. The Author(s).)

Introduction: Maternal diet during pregnancy has been linked to offspring allergy risk and it could represent a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models. Randomized-controlled trials on the effect of MD in preventing pediatric allergic diseases are still needed., Methods and Analysis: The Mediterranean Diet during Pregnancy study (PREMEDI) will be a 9-month multi-center, randomized-controlled, parallel groups, prospective trial. Healthy women (20-35 years) at their first trimester of pregnancy at risk for atopy baby, will be randomly allocated to Group 1 (standard obstetrical and gynecological follow-up and nutritional counseling to promote MD) or Group 2 (standard obstetrical and gynecological follow-up alone). 138 mother-child pair per group will be needed to detect a reduction in cumulative incidence of ≥1 allergic disease at 24 months of age. The primary study aim will be the evaluation of the occurrence of allergic disorders in the first 24 months of life. The secondary aims will be the evaluation of maternal weight gain, pregnancy/perinatal complications, growth indices and occurrence of other chronic disorders, mother-child pair adherence to MD and gut microbiome features, breastfeeding duration and breast milk composition, epigenetic modulation of genes involved in immune system, and metabolic pathways in the offspring., Ethics and Dissemination: The study protocol has been approved by the Ethics Committee of the University of Naples Federico II (number 283/21) and it will be conducted in accordance with the Helsinki Declaration (Fortaleza revision, 2013), the Good Clinical Practice Standards (CPMP/ICH/135/95), the Italian Decree-Law 196/2003 regarding personal data and the European regulations on this subject. The study has been registered in the Clinical Trials Protocol Registration System., Clinical Trial Registration: [http://clinicaltrials.gov], identifier [NCT05119868]., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Coppola, Paparo, Chiariotti, Ercolini, Nocerino, de Giovanni di Santa Severina, Carucci, De Filippis, Agangi, Napolitano, Passariello, Messina and Berni Canani.)

In resource-rich settings, advances in antiretroviral therapy have reduced the morbidity and increased the life expectancy of patients infected with HIV and consequently increased the likelihood of observing other non-HIV-related diseases in this group of patients. We report a high-risk pregnancy in a 26-year-old woman infected with HIV with complicated insulin-dependent diabetes mellitus. Because of maternal concomitant disease and concerns regarding potential antiretroviral toxicity on maternal disease, an abbreviated regimen of zidovudine prophylaxis was offered to prevent neonatal infection. After the iatrogenic preterm delivery of a healthy and uninfected baby, the patient experienced vulvar oedema and she is now waiting for renal transplantation.In conclusion, our case is one of a range of possible scenarios that may develop in pregnant women who are infected with HIV, reflecting the highly active antiretroviral therapy (HAART)-associated improvements in survival and health.

Purpose: To analyze the changes over two decades in HIV-infected pregnant women followed at a highly specialized regional center for antenatal care in southern Italy., Method: Since 1985, all HIV-infected pregnant women attending our center have been monitored using progressively updated protocols., Results: By December 2006, 230 deliveries in 159 women had been monitored. Deliveries in HIV-infected women increased from 0.16% (4/2,499) of all deliveries in 1985 to 0.73% (15/2,042) in 2006. The sociodemographic profile of the women changed greatly over the study period, and there was a shift from injecting drug use to heterosexual contact as the main transmission route and an increased proportion of foreign women. Subsequent to improvements in clinical care, the proportion of infected pregnant women receiving antiretroviral treatment increased from 27% (17/63) before 1996 to 81% (63/78) in 2006, with a corresponding decrease in the mother-to-child transmission rate from 36% (16/44) to 0.6% (1/157)., Conclusion: The increasing number of HIV-infected pregnant women can be attributed to nonselective antenatal HIV screening, the spread of HIV infection through heterosexual contacts, and the desire of HIV-infected women to have children. In this context, highly specialized reference centers can play an important role in providing HIV-infected pregnant women with optimal care and in reducing mother-to-child transmission rates to very low levels.