Evidence map›Paper›PMID 35526782›Full record

Trial reportAmerican journal of obstetrics & gynecology MFM2022

Amniocentesis to diagnose congenital cytomegalovirus infection following maternal primary infection.

Mara J Dinsmoor, Lida M Fette, Brenna L Hughes, Dwight J Rouse, George R Saade, Uma M Reddy, Donna Allard, Gail Mallett, Elizabeth A Thom, Cynthia Gyamfi-Bannerman and 15 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics & gynecology MFM, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.6field-weighted citation impact, top 10% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Review
  5. Cytomegalovirus and Pregnancy: A Narrative Review.Journal of clinical medicine · 2024
    Review
  6. Cytomegalovirus and pregnancy: current evidence for clinical practice.Revista da Associacao Medica Brasileira (1992) · 2024
    Article
  7. Article
  8. An Overview of Cytomegalovirus Infection in Pregnancy.Diagnostics (Basel, Switzerland) · 2022
    Review
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 2 countries.

Mara J DinsmoorDepartment of Obstetrics and Gynecology, Northwestern University, Chicago, IL (Dr Dinsmoor and Ms Mallett). Electronic address: mdinsmoor@comcast.net.
Lida M FetteThe George Washington University Biostatistics Center, Washington, DC (Drs Fette and Thom).
Brenna L HughesBrown University, Providence, RI.
Dwight J RouseBrown University, Providence, RI.
George R SaadeThe University of Texas Medical Branch, Galveston, TX (Dr Saade).
Uma M ReddyEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (Dr Reddy).
Donna AllardBrown University, Providence, RI.
Gail MallettDepartment of Obstetrics and Gynecology, Northwestern University, Chicago, IL (Dr Dinsmoor and Ms Mallett).
Elizabeth A ThomThe George Washington University Biostatistics Center, Washington, DC (Drs Fette and Thom).
Cynthia Gyamfi-BannermanColumbia University, New York, NY (Dr Gyamfi-Bannerman).
Michael W VarnerThe University of Utah Health Sciences Center, Salt Lake City, UT (Dr Varner).
William H GoodnightThe University of North Carolina at Chapel Hill, Chapel Hill, NC (Dr Goodnight).
Alan T N TitaThe University of Alabama at Birmingham, Birmingham, AL (Dr Tita).
Maged M CostantineThe Ohio State University, Columbus, OH (Dr Costantine).
Geeta K SwamyDuke University, Durham, NC (Dr Swamy).
Kent D HeyborneUniversity of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO (Dr Heyborne).
Edward K ChienCase Western Reserve University, Cleveland, OH (Dr Chien).
Suneet P ChauhanThe University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, TX (Dr Chauhan).
Yasser Y El-SayedStanford University, Stanford, CA (Dr El-Sayed).
Brian M CaseyThe University of Texas Southwestern Medical Center, Dallas, TX (Dr Parry).
Samuel ParryUniversity of Pennsylvania, Philadelphia, PA (Dr Casey).
Hyagriv N SimhanUniversity of Pittsburgh, Pittsburgh, PA (Dr Simhan).
Peter G NapolitanoMadigan Army Medical Center, Joint Base Lewis-McChord, WA (Dr Napolitano).
George A MaconesWashington University in St. Louis, MO (Dr Macones).
Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network
Brown University · USGeorge Washington University · USNorthwestern University · USCase Western Reserve University · USColumbia University · USDuke University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USMadigan Army Medical Center · USMemorial Hermann · USStanford University · USThe Ohio State University · USThe University of Texas Medical Branch at Galveston · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of Colorado Anschutz Medical Campus · USUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USUniversity of Pittsburgh · USUniversity of Utah · USWashington University in St. Louis · US

Funding

Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research NetU10HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI CLIFTON, REBECCA GERSNOVIEZ · 2009 to 2021
$174.2M
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
SARS-CoV-2 Vaccine Pregnancy RegistryU24HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI Rebecca Gersnoviez Clifton · 2021 to 2026
$39.2M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
NICHD Maternal Fetal Medicine Units NetworkU10HD034116 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI CASEY, BRIAN M · 1996 to 2015
$19.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD034208 · NICHD · UNIVERSITY OF UTAH · PI VARNER, MICHAEL W. · 1996 to 2015
$16.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD027869 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 1991 to 2015
$12.8M
NICHD Maternal Fetal Medicine Units NetworkU10HD040485 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAPNER, RONALD · 2001 to 2015
$12.5M
NICHD Maternal Fetal Medicine Units NetworkU10HD040560 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI THORP, JOHN M · 2001 to 2015
$10.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040545 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CHAUHAN, SUNEET P · 2001 to 2015
$7.7M
NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1 TR001873NICHD NIH HHS U10 HD027869NICHD NIH HHS U10 HD027915NICHD NIH HHS U10 HD034116NICHD NIH HHS U10 HD034208NICHD NIH HHS U10 HD036801NICHD NIH HHS U10 HD040485NICHD NIH HHS U10 HD040500NICHD NIH HHS U10 HD040512NICHD NIH HHS U10 HD040544NICHD NIH HHS U10 HD040545NICHD NIH HHS U10 HD040560NICHD NIH HHS U10 HD053097NICHD NIH HHS U10 HD068258NICHD NIH HHS U10 HD068268NICHD NIH HHS U10 HD068282NICHD NIH HHS U24 HD036801NICHD NIH HHS UG1 HD027869NICHD NIH HHS UG1 HD027915NICHD NIH HHS UG1 HD034116NICHD NIH HHS UG1 HD034208NICHD NIH HHS UG1 HD040485NICHD NIH HHS UG1 HD040500NICHD NIH HHS UG1 HD040512NICHD NIH HHS UG1 HD040544NICHD NIH HHS UG1 HD040545NICHD NIH HHS UG1 HD040560NICHD NIH HHS UG1 HD053097NICHD NIH HHS UG1 HD068258NICHD NIH HHS UG1 HD068268NICHD NIH HHS UG1 HD068282NICHD NIH HHS UG1 HD087192NICHD NIH HHS UG1 HD087230
6 · The paper itself

Abstract

backgroundCongenital cytomegalovirus infection following maternal primary cytomegalovirus infection affects approximately 0.4% of newborns in the United States but may be hard to diagnose prenatally.

objectiveTo evaluate the current sensitivity and specificity of amniocentesis in detecting congenital cytomegalovirus infection. STUDY

designSecondary analysis of a multicenter randomized placebo-controlled trial designed to evaluate whether cytomegalovirus hyperimmune globulin reduces congenital cytomegalovirus infection in neonates of individuals diagnosed with primary cytomegalovirus infection before 24 weeks of gestation. At randomization, subjects had no clinical evidence of fetal infection. Eligible subjects were randomized to monthly infusions of cytomegalovirus hyperimmune globulin or placebo until delivery. Although not required by the trial protocol, amniocentesis following randomization was permitted. The fetuses and neonates were tested for the presence of cytomegalovirus at delivery. Comparisons were made between those with and without amniocentesis and between those with cytomegalovirus-positive and negative results, using chi-square or Fisher exact test for categorical variables and the Wilcoxon rank sum test or t test for continuous variables. A P value of <.05 was considered significant.

resultsFrom 2012 to 2018, 397 subjects were included, of whom 55 (14%) underwent amniocentesis. Cytomegalovirus results were available for 53 fetuses and neonates. Fourteen amniocenteses were positive (25%). Gestational age at amniocentesis was similar between those with and without cytomegalovirus present, as was the interval between maternal diagnosis and amniocentesis. The prevalence of fetal or neonatal infection was 26% (14/53). The neonates of all 12 subjects with a positive amniocentesis and available results had cytomegalovirus infection confirmed at delivery, as did 2 neonates from the group of 41 subjects with a negative amniocentesis, with a sensitivity of 86% (95% confidence interval, 57-98), specificity of 100% (95% confidence interval, 91-100), positive predictive value of 100% (95% confidence interval, 74-100), and negative predictive value of 95% (95% confidence interval, 83-99). Amniocentesis-positive pregnancies were delivered at an earlier gestational age (37.4 vs 39.6 weeks; P<.001) and had lower birthweights (2583±749 vs 3428±608 g, P=.004) than amniocentesis-negative pregnancies.

conclusionAmniocentesis results are an accurate predictor of congenital cytomegalovirus infection.

Indexed as

Cytomegalovirus InfectionsPregnancy Complications, InfectiousAmniocentesisCytomegalovirusFemaleHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalPregnancycytomegalovirus in pregnancydiagnostic testingfetal infectionmaternal infectionneonatal cytomegalovirusprenatal diagnosisprimary infectionvertical transmission

Identifiers

PMID35526782
PMCPMC9167787
OpenAlexW4229039055

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

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.