Evidence map›Paper›PMID 34308309›Full record

ArticleEClinicalMedicine2021

Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial.

Susan E Carlson, Byron J Gajewski, Christina J Valentine, Elizabeth H Kerling, Carl P Weiner, Michael Cackovic, Catalin S Buhimschi, Lynette K Rogers, Scott A Sands, Alexandra R Brown and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02626299 (Assessment of DHA On Reducing Early Preterm Birth), which is not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
9.0field-weighted citation impact, top 2% 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.

NCT02626299 phase3completednot on this map

Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2016 to 2020Enrolled1,100ConditionsPreterm BirthArmsDocosahexaenoic acid - 800mg/day, Docosahexaenoic acid - 200mg/day, Placebo
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 83 citations in OpenAlex.

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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

13 authors at 5 institutions in 1 country.

Susan E CarlsonDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, United States.
Byron J GajewskiDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States.
Christina J ValentineDepartment of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, OH, United States.
Elizabeth H KerlingDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, United States.
Carl P WeinerDepartment of Obstetrics and Gynecology, University of Kansas Medical Center, Kansas City, KS, United States.
Michael CackovicDepartment of Obstetrics and Gynecology, Ohio State University, Columbus, OH, United States.
Catalin S BuhimschiDepartment of Obstetrics and Gynecology, University of Illinois, Chicago, Chicago, IL, United States.
Lynette K RogersNationwide Children's Hospital, Columbus, OH, United States.
Scott A SandsDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, United States.
Alexandra R BrownDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States.
Dinesh Pal MudaranthakamDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States.
Sarah A CrawfordDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, United States.
Emily A DeFrancoDepartment of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, OH, United States.
University of Kansas Medical Center · USUniversity of Cincinnati · USNationwide Children's Hospital · USThe Ohio State University · USUniversity of Illinois Chicago · US

Funding

Identification of dietary supplement practices and nutrient intake among a diverse US cohort of pregnant womenR01HD083292 · NICHD · UNIVERSITY OF KANSAS MEDICAL CENTER · PI CARLSON, SUSAN E, GAJEWSKI, BYRON J. · 2016 to 2020
$3.3M
NICHD NIH HHS R01 HD083292
6 · The paper itself

Abstract

backgroundSeveral meta analyses have concluded n-3 fatty acids, including docosahexaenoic acid (DHA), reduce early preterm birth (EPB, < 34 weeks), however, the amount of DHA required is unclear. We hypothesized that 1000 mg DHA per day would be superior to 200 mg, the amount in most prenatal supplements.

methodsThis randomised, multicentre, double-blind, adaptive-design, superiority trial was conducted in three USA medical centres. Women with singleton pregnancies and 12 to 20 weeks gestation were eligible. randomization was generated in SAS® by site in blocks of 4. The planned adaptive design periodically generated allocation ratios favoring the better performing dose. Managing study personnel were blind to treatment until 30 days after the last birth. The primary outcome was EPB by dose and by enrolment DHA status (low/high). Bayesian posterior probabilities (pp) were determined for planned efficacy and safety outcomes using intention-to-treat. The study is registered with ClinicalTrials.gov (NCT02626299) and closed to enrolment.

findingsEleven hundred participants (1000 mg,

interpretationClinicians could consider prescribing 1000 mg DHA daily during pregnancy to reduce EPB in women with low DHA status if they are able to screen for DHA.

fundingThe National Institutes of Health Child Health and Human Development (NICHD) funded the study. Life's DHA™-S oil, DSM Nutritional Products LLC, Switzerland provided all capsules.

Indexed as

Docosahexaenoic acid (DHA) amountEarly preterm birthGestation less than 34 weeksPregnancy

Identifiers

PMID34308309
PMCPMC8257993
OpenAlexW3161556645

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.