Trial reportFetal diagnosis and therapy2021
Serial Monitoring and Hyperimmunoglobulin versus Standard of Care to Prevent Congenital Cytomegalovirus Infection: A Phase III Randomized Trial.
Trial report in Fetal diagnosis and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- What are the neurodevelopmental outcomes of children with asymptomatic congenital cytomegalovirus infection at birth? A systematic literature review.Reviews in medical virology · 2024Pooled it
- Cytomegalovirus Infection in Pregnancy Prevention and Treatment Options: A Systematic Review and Meta-Analysis.Viruses · 2023Pooled it
- 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.Archives of gynecology and obstetrics · 2026Trial
- Efficacy of Immunoglobulin Therapy for Secondary Prevention of Congenital Cytomegalovirus Infection: A Systematic Review and Meta-Analysis.Open forum infectious diseases · 2026Review
- Possible role of hyperimmunoglobulin in reducing the risk of maternal-fetal transmission of cytomegalovirus in the valacyclovir era: a case series.Archives of gynecology and obstetrics · 2026Article
- Beyond hearing loss: exploring neurological and neurodevelopmental sequelae in asymptomatic congenital cytomegalovirus infection.Pediatric research · 2025Review
- Prenatal Screening for CMV Primary Infection: A Cost-Utility Model.BJOG : an international journal of obstetrics and gynaecology · 2025Article
- Current evidence gaps to support systematic cytomegalovirus screening in pregnancy.EClinicalMedicine · 2024Review
- Cytomegalovirus and Pregnancy: A Narrative Review.Journal of clinical medicine · 2024Review
- Cytomegalovirus seronegativity rate in pregnant women and primary cytomegalovirus infection during pregnancy in rural Germany.BMC pregnancy and childbirth · 2023Article
- Review
- Emerging Concepts in Congenital Cytomegalovirus.Pediatrics · 2022Review
- Potential of Anti-CMV Immunoglobulin Cytotect CPMicroorganisms · 2022Article
- Provider-Led Interventions to Reduce Congenital Cytomegalovirus.Journal of midwifery & women's healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNonrandomized studies support the potential of cytomegalovirus hyperimmunoglobulin (CMV-HyperIg) in preventing maternofetal CMV transmission, but prospective interventional studies show equivocal results. We pre-sent a prospective phase-III international randomized open-label trial on the potential effect of CMV-HyperIg following serial monitoring of CMV serostatus.
methodsCMV-seronegative pregnant women (gestational age [GA] <14 weeks) were 1:1 randomized to monthly CMV-serostatus monitoring and CMV-HyperIg upon seroconversion (treatment), or routine prenatal care with CMV-serostatus testing at end of pregnancy (control). Ethical considerations required that control subjects with confirmed seroconversion be offered Cytotect®. The primary endpoint was the proportion of fetuses/newborns with congenital CMV infection. Secondary endpoints included neonatal CMV disease and safety during the 24-month follow-up.
resultsThe treatment arm counted 4,800 randomized subjects: 52 seroconverted (median GA 24 [11-35] weeks), of which 45 completed follow-up. The control arm counted 4,735 randomized subjects: 42 seroconverted, of which 34 completed follow-up (evaluable data for 28 newborns) and 8 subjects chose off-label Cytotect®. Congenital CMV rates were 13/28 newborns (46.4% [CI 27.51; 66.13]) vs. 16/45 newborns (35.6% [CI 21.87; 51.22]) in control and treated arms, respectively (p = 0.46). Newborn CMV disease was mostly mild and spontaneously resolving. There were no major safety concerns. The target sample was not reached within an acceptable time frame.
conclusionsSerial monitoring of CMV serostatus with CMV-HyperIg treatment was associated with a mild nonsignificant reduction in the vertical CMV transmission rate. Studies on the optimal preventive strategy are hampered by epidemiological and ethical challenges and should focus on GA-dependent transmission rates and accurate dating of infection.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.