The Objective of our study was to investigate the influence of dietary (dGDM) and insulin-dependent (iGDM) gestational diabetes (GDM) on BDNF blood levels of corresponding maternal-neonatal pairs and compare them to pregnancies unaffected by GDM. Blood samples from 293 maternal-neonatal pairs were analyzed. Statistical analysis was performed using multiple regression analysis for association of log-transformed maternal and neonatal BDNF levels in relation to GDM, gestational age, neonatal sex, and mode of delivery. This was followed by a 2:1 matching of healthy and diabetic pairs. Maternal and neonatal BDNF levels were lowest in the iGDM group, followed by the dGDM group and healthy controls (maternal: healthy 665 ± 562 (26–2343) pg/mL vs. dGDM 593 ± 446 (25–1522) pg/mL vs. iGDM 541 ± 446 (68–2184) pg/mL; neonate: healthy 541 ± 464 (9.5–2802) pg/mL vs. dGDM 375 ± 342 (1–1491) pg/mL vs. iGDM 330 ± 326 (47–1384) pg/mL). After multiple regression analysis and additional 2:1 matching neonatal log-BDNF was significantly lower (−152.05 pg/mL, p = 0.027) in neonates of mothers with GDM compared to healthy pairs; maternal log-BDNF was also lower (−79.6 pg/mL), but did not reach significance. Our study is the first to analyze BDNF in matched maternal-neonatal pairs of GDM patients compared to a metabolically unaffected control group.

Purpose This phase 3, open-label, single-arm, prospective, multicenter clinical trial investigated the use of CMVIG to prevent maternal–fetal transmission. Methods Pregnant women with confirmed recent primary CMV infection with gestational age ≤ 14 weeks were treated with biweekly i.v. 200 U/kg BW CMVIG until at least GW 17. An amniocentesis was performed between GW 19–22. Results Fourty eight women were treated with a mean (range) number of 5.1 (4–7) infusions of CMVIG. Maternal–fetal transmission at AC was found in 11 cases (22.9%), of them 9 in the periconceptional (n = 37, 24.3%) and 2 in the first trimester subgroup (n = 11, 18.2%). One additional maternal–fetal transmission was diagnosed at birth (total 12 cases, 25.0%). Twenty three mothers, fetuses and newborns (24.0% of 96 total lives) experienced 27 serious adverse events, including the maternal–fetal transmissions. Of these, 18, 6 and 3 events were classified as mild, moderate and severe, respectively. Sixty three of the total lives (65.6%) experienced 386 adverse events (AEs) after the start of the treatment, predominantly of mild severity. Twenty one mild AEs in 6 women were related to the CMVIG administration. The only adverse drug reaction that was observed in more than one woman was headache (4 = 8.3%). No AEs were observed that led to death, abortion, trial withdrawal, CMVIG dose interruption, infusion rate or dose reduction. The newborn data were comparable to the general population, without evidence for an increased risk of premature birth or growth retardation. Conclusion Despite a favorable safety profile, the benefit of treatment with CMVIG to prevent a maternal–fetal CMV transmission could not be demonstrated in our trial.