In utero treatment of congenital cytomegalovirus infection with valganciclovir: an observational study on safety and effectiveness.

BACKGROUND: The treatment of congenital cytomegalovirus (CMV) infection is usually administered to neonates after birth; however, it can be anticipated during the prenatal period by treating pregnant women in order to reduce the severity of the congenital disease. The most commonly used treatment for CMV during pregnancy is valaciclovir; however, valganciclovir has a higher potency against CMV and is the first choice for neonates with congenital CMV disease. OBJECTIVES: We investigated neonatal and maternal safety of tertiary prevention in infected fetuses showing ultrasound features of infection using valganciclovir. METHODS: Retrospective cohort study of pregnant women and their symptomatic infected fetuses taking valganciclovir, 3 × 450 mg per day. All fetuses presented at least one prenatal feature on ultrasound. We assessed fetal/neonatal and maternal safety, as well as neonatal efficacy of treatment. The main outcome was neutropenia. Secondary outcomes included other haematological side effects, symptoms at birth and neonatal CMV-PCR was positive. RESULTS: Seventeen women with singleton pregnancies received valganciclovir from a median (IQR) of 27.1 (26.0-30.3) to 11.6 (6.5-12.9) weeks of gestation. No neonatal neutropenia was reported. One pregnancy was terminated for severe features. Three newborns (18%) were asymptomatic at birth, including one with negative CMV-PCR from blood and saliva. CMV-PCR was positive for 12/13 symptomatic newborns, with a median (IQR) log10 viral load of 3.36 (3.30-4.20), 4.03 (1.75-4.27) and 3.04 (0.00-3.40) log10 copies/mL in blood, urine and saliva, respectively. CONCLUSIONS: Tertiary prevention by valganciclovir appears to be well tolerated for both fetus and mother. However, more extensive trials accompanied by long-term follow-up are needed.

Effectiveness of prophylactic carbetocin versus oxytocin following vaginal delivery for preventing severe postpartum hemorrhage.

OBJECTIVE: To compare the effectiveness of prophylactic carbetocin with prophylactic oxytocin for preventing severe postpartum hemorrhage (PPH) following vaginal delivery. METHODS: This before and after cohort study took place between 2020 and 2021 in a university maternity hospital. In 2021, the protocol for PPH prevention immediately after vaginal delivery changed: intravenous oxytocin (5 IU) was replaced by intravenous carbetocin (100 µg). All patients with vaginal births were included, with two groups compared: patients who received prophylactic oxytocin in 2020 and those who received prophylactic carbetocin in 2021. The primary outcome was severe PPH, defined as one or more of the following: estimated blood loss ≥1500 mL, transfusion ≥4 units of red blood cells, Bakri balloon use, embolization, vascular ligation, hysterectomy, and maternal death. RESULTS: Among 4832 women included, 2417 received oxytocin and 2415 received carbetocin. The rate of severe PPH was similar in both groups (0.5% vs. 0.6%, respectively; adjusted odds ratio, 0.8 [95% confidence interval, 0.4-1.8]). The rate of PPH ≥500 mL was lower in the carbetocin group (4% vs. 5.8%; P = 0.004). CONCLUSION: Although prophylactic carbetocin was associated with a reduction in the rate of PPH ≥500 mL, carbetocin is no different to oxytocin in preventing severe PPH caused by atony after vaginal delivery.