Evidence map›Paper›PMID 24113254›Full record

Trial reportAmerican journal of obstetrics and gynecology2014

Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth.

Steve N Caritis, Raman Venkataramanan, Elizabeth Thom, Margaret Harper, Mark A Klebanoff, Yoram Sorokin, John M Thorp, Michael W Varner, Ronald J Wapner, Jay D Iams and 7 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 7% 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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Omega-3 fatty acid addition during pregnancy.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Pharmacogenomics of preterm birth prevention and treatment.BJOG : an international journal of obstetrics and gynaecology · 2016
    Review
  19. Article
  20. Basic obstetric pharmacology.Seminars in perinatology · 2014
    Review
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

17 authors at 14 institutions in 1 country.

Steve N CaritisDepartment of Obstetrics and Gynecology and Reproductive Sciences and Pharmaceutical Sciences, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, PA.
Raman VenkataramananDepartment of Obstetrics and Gynecology and Reproductive Sciences and Pharmaceutical Sciences, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, PA.
Elizabeth ThomThe George Washington University Biostatistics Center, Washington, DC.
Margaret HarperDepartment of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, and University of North Carolina at Chapel Hill, Chapel Hill, NC.
Mark A KlebanoffMaternal-Fetal Medicine Units, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.
Yoram SorokinDepartment of Obstetrics and Gynecology, Wayne State University, Detroit, MI.
John M ThorpDepartment of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, and University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michael W VarnerDepartment of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT.
Ronald J WapnerDepartment of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY.
Jay D IamsDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, OH.
Marshall W CarpenterDepartment of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI.
William A GrobmanDepartment of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL.
Brian M MercerDepartment of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, OH.
Anthony SciscioneDrexel University College of Medicine, Philadelphia, PA.
Dwight J RouseDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL.
Susan RaminDepartment of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, Houston, TX.
Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and Obstetric-Fetal Pharmacology Research Units Network
University of Pittsburgh · USWake Forest University · USBrown University · USColumbia University · USDrexel University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USGeorge Washington University · USMetroHealth Medical Center · USNorthwestern University · USThe Ohio State University · USThe University of Texas Health Science Center at Houston · USUniversity of Alabama at Birmingham · USUniversity of Utah · USWayne State University · 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 DEARBORN, DORR GELLATLY · 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
Carolina Population CenterR24HD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MORGAN, SAMUEL PHILIP · 2005 to 2014
$10.0M
Pregnancy and Drug Metabolizing Enzymes and TransportersU10HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2004 to 2014
$9.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NCATS NIH HHS UL1 TR000439NCRR NIH HHS M01 RR000080NCRR NIH HHS MO1-RR-000080NICHD NIH HHS HD047905NICHD 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 R24 HD050924NICHD 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 U10 HD047905NICHD NIH HHS U24 HD036801NICHD NIH HHS U54 HD047905NICHD 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

objective17-alpha hydroxyprogesterone caproate 250 mg weekly reduces recurrent spontaneous preterm birth in women with a prior spontaneous preterm birth by 33%. The dose is not based on pharmacologic considerations. A therapeutic concentration has not been determined hampering any attempt to optimize treatment. This study evaluated the relationship between 17-alpha hydroxyprogesterone caproate plasma concentrations and the rate of spontaneous preterm birth in women with singleton gestation. STUDY

designA single blood sample was obtained between 25 and 28 weeks' gestation from 315 women with a spontaneous preterm birth who participated in a placebo-controlled, prospective, randomized clinical trial evaluating the benefit of omega-3 supplementation in reducing preterm birth. All women in the parent study received 17-alpha hydroxyprogesterone caproate and 434 received omega-3 supplementation and 418 received a placebo. Plasma from 315 consenting women was analyzed for 17-alpha hydroxyprogesterone caproate concentration.

resultsThere were no differences between placebo and omega-3 supplemented groups in demographic variables, outcomes or in mean 17-alpha hydroxyprogesterone caproate concentration. Plasma concentrations of 17-alpha hydroxyprogesterone caproate ranged from 3.7-56 ng/mL. Women with plasma concentrations of 17-alpha hydroxyprogesterone caproate in the lowest quartile had a significantly higher risk of spontaneous preterm birth (P = .03) and delivered at significantly earlier gestational ages (P = .002) than did women in the second to fourth quartiles. The lowest preterm birth rates were seen when median 17-alpha hydroxyprogesterone caproate concentrations exceeded 6.4 ng/mL.

conclusionLow plasma 17-alpha hydroxyprogesterone caproate concentration is associated with an increased risk of spontaneous preterm birth. This finding validates efficacy of this treatment but suggests that additional studies are needed to determine the optimal dosage.

Indexed as

17 alpha-Hydroxyprogesterone CaproateFatty Acids, Omega-3FemaleHumansHydroxyprogesteronesPregnancyPregnancy Trimester, SecondPremature BirthRecurrence17 alpha-Hydroxyprogesterone CaproateFatty Acids, Omega-3Hydroxyprogesterones17-hydroxyprogesterone caproate concentration-responsedose responsepharmacodynamics

Identifiers

PMID24113254
PMCPMC3926421
OpenAlexW1984974395

What OpenQuestion holds

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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.