Evidence map›Paper›PMID 23635681›Full record

Trial reportObstetrics and gynecology2013

Change in mononuclear leukocyte responsiveness in midpregnancy and subsequent preterm birth.

Margaret Harper, Liwu Li, Yuan Zhao, Mark A Klebanoff, John M Thorp, Yoram Sorokin, Michael W Varner, Ronald J Wapner, Steve N Caritis, Jay D Iams and 8 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00135902 (A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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.

NCT00135902 phase3completednot on this map

A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk

TypeinterventionalSponsorThe George Washington University Biostatistics CenterRan2005 to 2008Enrolled800ConditionsPreterm BirthArms17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement, 17 alpha-hydroxy progesterone caproate and Placebo supplement
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Omega-3 fatty acid addition during pregnancy.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Maternal-fetal cross talk through cell-free fetal DNA, telomere shortening, microchimerism, and inflammation.American journal of reproductive immunology (New York, N.Y. : 1989) · 2018
    Review
  7. Maternal plasma-soluble ST2 concentrations are elevated prior to the development of early and late onset preeclampsia - a longitudinal study.The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · 2018
    Article
  8. Article
  9. Article
  10. 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

18 authors at 1 institution in 1 country.

Margaret HarperDepartments of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Wayne State University, Detroit, Michigan, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, Women and Infants Hospital, Brown University, Providence, Rhode Island, Northwestern University, Chicago, Illinois, Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio, Drexel University College of Medicine, Philadelphia, Pennsylvania, the University of Alabama at Birmingham, Birmingham, Alabama, the University of Texas Health Science Center at Houston, Houston, Texas, and the University of Texas Medical Branch, Galveston, Texas; the Division of Inflammation Biology and Immunology, Department of Biological Sciences, Virginia Polytechnic Institute and State University, Blacksburg, Virginia; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Liwu Li
Yuan Zhao
Mark A Klebanoff
John M Thorp
Yoram Sorokin
Michael W Varner
Ronald J Wapner
Steve N Caritis
Jay D Iams
Marshall W Carpenter
Alan M Peaceman
Brian M Mercer
Anthony Sciscione
Dwight J Rouse
Susan M Ramin
Garland D Anderson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*
State University of New York · 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 Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
SARS-CoV-2 Vaccine Pregnancy RegistryU24HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI Rebecca Gersnoviez Clifton · 2021 to 2026
$39.2M
MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTRU01HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI THOM, ELIZABETH ANN · 1998 to 2008
$27.0M
Zosuquidar trihydrochloride for acute myeloid leukemia &refractory anemiaM01RR000080 · NCRR · UNIVERSITY HOSPITALS OF CLEVELAND · PI DAVIS, PAMELA B · 1985 to 2007
$22.2M
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 NetworkU10HD027917 · NICHD · WAYNE STATE UNIVERSITY · PI GONIK, BERNARD · 1991 to 2015
$8.2M
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NCATS NIH HHS UL1 TR000439NCRR NIH HHS M01 RR000080NCRR NIH HHS MO1-RR-000080NICHD NIH HHS HD21410NICHD NIH HHS HD27860NICHD NIH HHS HD27869NICHD NIH HHS HD27915NICHD NIH HHS HD27917NICHD NIH HHS HD34136NICHD NIH HHS HD34208NICHD NIH HHS HD36801NICHD NIH HHS HD40485NICHD NIH HHS HD40500NICHD NIH HHS HD40512NICHD NIH HHS HD40544NICHD NIH HHS HD40545NICHD NIH HHS HD40560NICHD NIH HHS U01 HD019897NICHD NIH HHS U01 HD036801NICHD NIH HHS U10 HD021410NICHD NIH HHS U10 HD027860NICHD NIH HHS U10 HD027869NICHD NIH HHS U10 HD027915NICHD NIH HHS U10 HD027917NICHD NIH HHS U10 HD034136NICHD 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 U24 HD036801NICHD NIH HHS UG1 HD027869NICHD NIH HHS UG1 HD027915NICHD 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 HD040560
6 · The paper itself

Abstract

objectiveTo estimate the associations of change in immune response with preterm delivery, omega-3 supplementation, and fish diet.

methodsThis was an ancillary study to a randomized trial of omega-3 fatty acid supplementation for the prevention of recurrent preterm birth. In vitro maternal peripheral blood mononuclear leukocyte production of the anti-inflammatory cytokine, interleukin-10, and the proinflammatory cytokine, tumor necrosis factor-α, in response to stimulation with lipopolysaccharide, was measured at 16-22 weeks of gestation (baseline) and again at 25-28 weeks of gestation (follow-up) among women with prior spontaneous preterm birth. Changes in concentrations from baseline to follow-up ([INCREMENT]) were compared separately among groups defined by gestational age category at delivery, fish diet history, and omega-3 compared with placebo treatment assignment with Kruskal-Wallis tests.

resultsInterleukin-10 [INCREMENT] differed by gestational age category among 292 women with paired assays. Concentrations increased less in women delivering between 35 and 36 6/7 weeks of gestation (48.9 pg/mL) compared with women delivering at term (159.3 pg/mL) and decreased by 65.2 pg/mL in women delivering before 35 weeks of gestation (P=.01). Tumor necrosis factor-α Δ also differed by gestational age category among 319 women, but the pattern was inconsistent. Those delivering between 35 and 36 6/7 weeks of gestation exhibited decreased concentrations of tumor necrosis factor-α at follow-up compared with baseline (-356.0 pg/mL); concentrations increased among women delivering before 35 weeks of gestation and those delivering at term, 132.1 and 86.9 pg/mL (P=.03). Interleukin-10 Δ and tumor necrosis factor-α Δ were unaffected by either omega-3 supplementation or fish diet.

conclusionRecurrent preterm birth was associated with decreased peripheral blood mononuclear leukocyte production of interleukin-10 in response to a stimulus during the second trimester. CLINICAL

trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00135902. LEVEL OF EVIDENCE: II.

Indexed as

AdultAnimalsDietary SupplementsFatty Acids, Omega-3FemaleFishesHumansInterleukin-6Leukocytes, MononuclearPregnancyPregnancy Trimester, SecondPremature BirthTumor Necrosis Factor-alphaYoung AdultFatty Acids, Omega-3Interleukin-6Tumor Necrosis Factor-alpha

Identifiers

PMID23635681
PMCPMC3830536
OpenAlexW2071622516

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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.