A Randomized, Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy
2008 · paper · Clinical trials
A placebo-controlled trial of magnesium sulfate given to 2241 women at imminent risk of delivery at 24–31 weeks, testing prevention of cerebral palsy. The combined outcome of death or cerebral palsy did not differ, but moderate or severe cerebral palsy was less frequent with treatment.
1 finding
Substance Table 5 major congenital anomaly row: "47/1112 (4.0)" and "33/1184 (2.7)". The printed percentages and RR 1.51 fit the live-born denominators 1174/1244, not the printed 1112/1184.
- p. 16 Table 5, Major congenital anomaly row
47/1112 (4.0)
- p. 16 Table 5, Major congenital anomaly row
33/1184 (2.7)
Only the authors can say what is right here.
Judge's note: Read on the page 16 image. 47/1112 = 4.2% and 33/1184 = 2.8%, which do not match the printed 4.0% and 2.7%. 47/1174 = 4.0% and 33/1244 = 2.7%, and their ratio is 1.51, matching the printed RR exactly; the printed denominators give 1.52. The row seems to have copied the cranial-ultrasound denominators from the rows above. Only the authors can confirm which values are right.
Second check: another model agreed
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10 minor (typos and the like; most checked by the judge only)
Wording Discussion says magnesium gave "a significant decrease in the risk of moderate or severe cerebral palsy among surviving children", but the significant result reported (20/1041 vs 38/1095, RR 0.55, P = 0.03; Table 2) uses all pregnancies as the denominator.
- p. 5 Discussion, first paragraph
a slight but non-significant increase in the risk of fetal or infant death and a significant decrease
- p. 6 Discussion, first paragraph (continued)
in the risk of moderate or severe cerebral palsy among surviving children
- p. 12 Table 2, All pregnancies
20/1041 (1.9)
- p. 2 Abstract, Conclusions
although the rate of cerebral palsy was reduced among survivors
Judge's note: Table 2 and the Results (p.5) compute the moderate/severe CP comparison over all pregnancies. No survivor-based test of moderate/severe CP is reported. The abstract conclusion ('the rate of cerebral palsy was reduced among survivors') is supported by the Results text: any CP in 40/942 vs 73/1002 (4.2% vs 7.3%, P = 0.004), with survivor denominators. So only the Discussion wording is loose. The numerators are the same and the survivor-based rates still favour magnesium, so this is a minor wording point.
Second check: another model agreed
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Wording Methods state "GMFCS scores can range from 0 to 5", while the paper's own severity grades begin at level 1 (mild = level 1).
- p. 3
GMFCS scores can range from 0 to 5
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the GMFCS is defined with levels I to V, with no level 0. The page 3 image shows '0 to 5' as quoted. The study may have coded 0 for no motor impairment, so only the authors can say whether '0' is intended.
Second check: another model agreed
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Wording Figure 1 says "1087 Women were included in the maternal outcomes analysis" in the magnesium arm, but every denominated obstetrical outcome in Table 4 uses 1086 (e.g. "127/1086 (11.7)"); the placebo arm agrees (1141 in both).
- p. 10 Figure 1, bottom left box
1087 Women were included in the maternal outcomes analysis
- p. 15 Table 4, obstetrical outcomes rows
127/1086 (11.7)
- p. 10 Figure 1, bottom box
1087 Were included in the maternal outcomes analysis
Only the authors can say what is right here.
Judge's note: Read on the page 10 and page 15 images. The magnesium-arm obstetrical rows (chorioamnionitis, cesarean, endometritis, pulmonary edema) all use 1086; the placebo rows use 1141, matching Figure 1. Neither the Table 4 footnotes nor the text explain the one-woman difference. It could be missing outcome data, so this is an author query.
Second check: another model agreed
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Typo Reprint footnote ends the e-mail address with a doubled period: "drouse@uab.edu.."
- p. 1 Reprint address footnote
drouse@uab.edu..
Judge's note: The page 1 crop shows the doubled period after the e-mail address, so it is not an extraction artefact.
Second check: none (judge only)
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Typo Stray space inside a word in the Study Outcomes section: "abnormality in mus cle tone"
- p. 3 Study Outcomes, cerebral palsy diagnostic criteria
abnormality in mus cle tone
Judge's note: The page 3 crop shows the visible gap in 'mus cle'.
Second check: none (judge only)
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Typo Extra 'of': "moderate cerebral palsy as a grade of level of 2 or 3"; the parallel phrases are 'grade of level 1' and 'grade of level 4 or 5'.
- p. 3 Study outcomes, last paragraph
as a grade of level of 2 or 3
Judge's note: Confirmed on the page 3 crop.
Second check: none (judge only)
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Typo Reference 9 gives the co-author as "Hirtz DG, Nelson KN.", while references 3, 8 and 13 give the same author as "Nelson KB".
- p. 8 Reference 9
Hirtz DG, Nelson KN.
- p. 8 Reference 8
Nelson KB, Grether JK.
- p. 8 Reference 9
Hirtz DG, Nelson KN. Magnesium sulfate and cerebral palsy in premature infants.
- p. 8 Reference 9
Hirtz DG, Nelson KN
Judge's note: Read on the page 8 image. References 3, 8 and 13 print 'Nelson KB'; reference 9 prints 'Nelson KN'. This is an internal inconsistency in the author initials.
Second check: none (judge only)
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Typo Reference 18 gives one person's initials two ways: "Stevenson, RE.; Hall, JG. Terminology.. In: Stevenson, RE.; Hall, JD.; Goodman, RM., editors." It also has a doubled period after 'Terminology'.
- p. 9 Reference 18
Stevenson, RE.; Hall, JG. Terminology.. In: Stevenson, RE.; Hall, JD.; Goodman, RM., editors.
- p. 9 Reference 18
Hall, JG.; Goodman
Judge's note: The page 9 image shows 'Hall, JG.' as chapter author and 'Hall, JD.' among the editors of the same book in the same entry, plus 'Terminology..'.
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Typo Reference 32 prints the author surname as "Permanyear-Miralda G".
- p. 9 Reference 32
Montori VM, Permanyear-Miralda G, Ferreira-González I
- p. 9 Reference 32
Montori VM, Permanyear-Miralda G, Ferreira-González I, et al.
- p. 9 Reference 32
Permanyear-Miralda G
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the co-author of the BMJ 2005 composite end points paper is spelled Permanyer-Miralda. The page 9 image shows 'Permanyear-Miralda' as quoted.
Second check: none (judge only)
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Typo Figure 1 placebo allocation box reads "101 Received placepo for <3 hr" (should be 'placebo').
- p. 10 Figure 1, placebo allocation box
101 Received placepo for <3 hr
Judge's note: The placebo allocation box on the page 10 image reads 'placepo'. The line above it reads 'placebo'.
Second check: none (judge only)