Safety of a cytomegalovirus-specific hyperimmunoglobulin in the prevention of maternal-fetal transmission after primary infection-results of an open-label, single-arm, prospective trial.

ABSTRACT:

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 newborn

SUBMITTER: Kagan KO 

PROVIDER: S-EPMC12789126 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature