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Induction of Labour versus Expectant Monitoring for Gestational Hypertension or Mild Pre-eclampsia after 36 Weeks' Gestation (HYPITAT)

2009 · paper · Clinical trials

A Dutch randomized trial of 756 women with gestational hypertension or mild pre-eclampsia after 36 weeks, comparing induced labour with expectant monitoring. Poor maternal outcomes occurred in 31% with induction versus 44% with monitoring.

2 findings

Substance Table 1, Education, randomised induction column (n=377): the counts 6, 12, 39, 112, 55, 17 and 'Unknown 135 (36%)' sum to 376, not 377.
  • p. 3 Table 1, Education, Induction of labour (randomised) column
    135 (36%)

Only the authors can say what is right here.

Judge's note: Read the column on the p3 image. The other three columns sum exactly to their n (379, 73, 324). The table footnote reports missing data only for smoking, and 'Unknown' is already a category, so one woman is not accounted for. 135/377 and 136/377 both round to 36%, so only the authors can say which count is off.

Second check: another model agreed

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Reference or label References 19 (Cunningham FG, 'Severe preeclampsia and eclampsia: systolic hypertension is also important') and 20 (Martin JN Jr et al, 'Stroke and severe preeclampsia and eclampsia...') both give "Obstet Gynecol 2005; 105: 246–54."
  • p. 10 Reference 19
    hypertension is also important. Obstet Gynecol 2005; 105: 246–54.
  • p. 10 Reference 20
    shift focusing on systolic blood pressure. Obstet Gynecol 2005; 105: 246–54.
  • p. 10 Reference 19
    Cunningham FG. Severe preeclampsia and eclampsia: systolic hypertension is also important. Obstet Gynecol 2005; 105: 246–54.
  • p. 10 References 19 and 20
    Obstet Gynecol 2005; 105: 246–54.

Only the authors can say what is right here.

Judge's note: The image of p10 confirms the identical journal, year, volume and pages for two different articles by different authors, so at least one entry is wrong. The correct pages for Cunningham's piece cannot be established from the files, so the authors need to supply them.

Second check: another model agreed

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16 minor (typos and the like; most checked by the judge only)
Substance Table 4, Fetal distress, expectant monitoring: '20 (27%)'. With the 72 caesarean sections as denominator, 20/72 = 27.8%, which rounds to 28%.
  • p. 6 Table 4, Fetal distress, Expectant monitoring
    20 (27%)

Judge's note: Checked on the p6 image. Every other row in both columns rounds correctly against 72 and 54. Printed as 27%, the column totals 100%; with 28% it would total 101%. The figure may therefore have been adjusted to force a 100% total, but other tables (for example Table 1 education) are not adjusted this way.

Second check: another model agreed

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Wording The randomisation stratification factor is worded two ways: 'stratified for centre, parity, and hypertensive-related disease (gestational hypertension or pre-eclampsia)' (p2) and 'stratified for centre, parity, and presence of proteinuria' (p4).
  • p. 2 Methods, Patients
    Randomisation was stratifi ed for centre, parity, and hypertensive-related disease
  • p. 4 Statistical analysis
    stratifi ed for centre, parity, and presence of proteinuria
  • p. 2 Methods, Patients
    stratifi ed for centre, parity, and hypertensive-related disease

Judge's note: Both passages checked on the page images (p2 Patients, p4 Statistical analysis). The paper defines pre-eclampsia as hypertension plus proteinuria, so in this population the two factors are probably the same thing. Only the wording differs, so this is a minor consistency point.

Second check: another model agreed

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Wording The text says missing values for primary-outcome components 'ranged from 0% for maternal mortality and eclampsia to 2% for post-partum haemorrhage', but the Table 3 footnote for severe proteinuria, a primary-outcome component, says 'Data are missing for some participants: n=157 for induction of labour, and n=191 for expectant monitoring'.
  • p. 6 Results, paragraph on primary outcome
    ranged from 0% for maternal mortality and eclampsia to 2% for post-partum haemorrhage
  • p. 5 Table 3 footnote *
    n=157 for induction of labour, and n=191 for expectant monitoring
  • p. 4 Statistical analysis
    missing data for relevant outcome measures were negligible
  • p. 5 Table 3 footnote
    *Data are missing for some participants: n=157 for induction of labour, and n=191 for

Only the authors can say what is right here.

Judge's note: Both passages read on the p5 and p6 images. The proportions 3 (2%) and 4 (2%) match denominators of 157 and 191, so those n are the women with data, and about half of each arm lacks a value. The Methods say 24-h urine was collected only after a positive protein screen, which may explain the gap. However, the paper does not reconcile this with the 0–2% statement or with 'missing data … were negligible'.

Second check: another model agreed

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Wording Induction-timing categories overlap: '11 (3%) were induced 2–4 days after randomisation, and two (1%) were induced 4 days after randomisation'. The last category presumably means more than 4 days.
  • p. 5 Results, last lines of right column
    11 (3%) were induced 2–4 days after randomisation, and two (1%) were induced 4 days after

Judge's note: The p5 image reads '4 days after', with no '>' symbol. The counts are consistent (288+65+11+2=366), but as printed the last two categories are not mutually exclusive.

Second check: another model agreed

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Wording The Discussion states 'The reduced risk of caesarean section that we recorded after induction of labour' and 'reduced risk of severe hypertension or HELLP syndrome and subsequent reduced need for caesarean section', but the Results call the caesarean difference 'not significant' (Table 4: 0·75 [0·55–1·04; 0·085]) and the HELLP difference 'not significant' (Table 3: 0·37 [0·12–1·14; 0·07]).
  • p. 7 Discussion, para 1
    Surprisingly, fewer caesarean sections were needed in the induction group than the expectant monitoring group.
  • p. 7 Discussion, para 3
    The reduced risk of caesarean section that we recorded after induction of labour
  • p. 8 Discussion, para 5
    this intervention probably reduces the risk of caesarean section
  • p. 6 Table 4, Caesarean section row; Results text
    0·75 (0·55–1·04; 0·085)*

Only the authors can say what is right here.

Judge's note: Checked p5, p6, p7, p8 and p9. 'Fewer caesarean sections' is literally true of the raw counts (54 vs 72). However, 'reduced risk ... that we recorded' and 'reduced need' present the caesarean and HELLP differences as findings, and the paper's own Results describe both as non-significant.

Second check: another model agreed

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Wording Final paragraph: "Our finding that induction of labour was associated with a reduced risk of severe hypertension or HELLP syndrome and subsequent reduced need for caesarean section". The Results describe the HELLP difference (Table 3: 4 [1%] vs 11 [3%], 0·37 [0·12–1·14; 0·07]) and the caesarean difference (Table 4: 54 [14%] vs 72 [19%], 0·75 [0·55–1·04; 0·085]) as not significant.
  • p. 9 Discussion, final paragraph
    associated with a reduced risk of severe hypertension or HELLP syndrome and subsequent reduced need for caesarean section
  • p. 5 Table 3, HELLP syndrome row
    0·37 (0·12–1·14; 0·07)

Only the authors can say what is right here.

Judge's note: Confirmed Table 3 on p5 and Table 4 on p6. The p6 Results text says that for HELLP 'the difference between intervention groups was not significant', and for caesarean section 'the difference was not significant (table 4)'. The concluding sentence on p9 presents both as findings. The wording goes further than the paper's own Results.

Second check: another model agreed

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Wording Discussion says "when we recalculated the occurrence of the primary endpoint with progression to severe disease diagnosed from at least two measurements of high blood pressure, the treatment benefit of induction was also clear", but the only recalculation in the Results (11% [n=42] vs 19% [n=73]; 0·58) is labelled as progression to severe disease, not the composite primary endpoint.
  • p. 7 Discussion, para 2
    recalculated the occurrence of the primary endpoint with progression to severe disease diagnosed from at least two measurements
  • p. 6 Results, maternal outcome paragraph
    when progression to severe disease was diagnosed from high blood pressure measured on at least two occasions

Only the authors can say what is right here.

Judge's note: Checked p6 Results: after progression to severe disease (23% vs 36%), the text says 'The treatment effect was similar when progression to severe disease was diagnosed from high blood pressure measured on at least two occasions more than 6 h apart (11% [n=42] vs 19% [n=73]...)'. On p7 the Discussion says the primary endpoint was recalculated. No recalculated composite is reported. Table 3 gives only the 'Severe hypertension measured twice' component rows. Only the authors can say which quantity the 11%/19% figures refer to, or whether a recalculated composite exists.

Second check: another model agreed

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Wording The Discussion says 'Adverse neonatal outcomes did not differ significantly between the groups', while Table 5 reports arterial pH <7·05 as '0·46 (0·21–1·00; 0·043)', and the Results highlight it as lower in the induction group.
  • p. 7 Discussion, para 1
    Adverse neonatal outcomes did not differ significantly between the groups.
  • p. 7 Table 5, Arterial pH <7·05 row
    0·46 (0·21–1·00; 0·043)§
  • p. 7 Discussion para 1
    Adverse neonatal outcomes did not diff er

Judge's note: Checked on the p7 image. The statement holds for the composite neonatal outcome (p=0·276), but the unqualified plural conflicts with the one component the Results single out. Adding 'composite' would resolve it.

Second check: another model agreed

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Wording Figure 3 (Risk of caesarean section), cervical position Posterior, induction of labour: "30/207 (15%)". 30/207 = 14·49%, which rounds to 14%.
  • p. 9 Figure 3, cervical position Posterior, induction of labour column
    30/207 (15%)

Judge's note: The image of p9 shows 30/207 (15%). The printed RR 0·62 matches 30/207 vs 44/188, so the count is consistent and the percentage is the error.

Second check: another model agreed, code check

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Typo The time gap for the two-measurement definition is worded differently: Methods "a minimum of 6 h apart" and Discussion "at least 6 h apart", but Results "on at least two occasions more than 6 h apart".
  • p. 7 Discussion, para 2
    measurements of high blood pressure at least 6 h apart
  • p. 6 Results, maternal outcome paragraph
    on at least two occasions more than 6 h apart
  • p. 2 Methods, outcomes
    a minimum of 6 h apart

Judge's note: I confirmed all three wordings in the images of p2, p6 and p7. The Methods and Discussion say ≥6 h and the Results say >6 h. This is probably loose wording for the same analysis, so I treat it as a minor consistency point.

Second check: none (judge only)

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Typo Table 5 subheading: 'Reasons for admission to an neonatal intensive care unit' should read 'a neonatal'.
  • p. 7 Table 5, subheading
    Reasons for admission to an neonatal intensive care unit

Judge's note: The p7 image shows 'an neonatal'.

Second check: none (judge only)

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Typo Discussion: "This paradoxal finding is explained"; the standard form is 'paradoxical'.
  • p. 9 Discussion, unfavourable cervix paragraph
    This paradoxal finding is explained

Judge's note: The image of p9 shows 'paradoxal'. It is a rare variant, so this is a cosmetic house-style point only.

Second check: none (judge only)

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Typo Reference 23: "Maternal-Fetal Medicin Units Network" should be 'Medicine'.
  • p. 10 Reference 23
    Maternal-Fetal Medicin Units Network

Judge's note: The image of p10 shows 'Medicin' in the middle of a line, so this is not a hyphenation or extraction artefact.

Second check: none (judge only)

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Typo Reference 14: "NVOGnet voorlichting & richtlijen". The Dutch word is 'richtlijnen'; the URL in the same reference uses 'richtlijn'.
  • p. 10 Reference 14
    NVOGnet voorlichting & richtlijen
  • p. 10 Reference 14
    NVOGnet voorlichting & richtlijen.

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: the Dutch spelling 'richtlijnen'. The image of p10 shows 'richtlijen', and the URL in the same entry has 'richtlijn', which supports a misspelling.

Second check: none (judge only)

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Typo Collaborators list: "Kennermer Gasthuis, Haarlem" (the hospital is the Kennemer Gasthuis).
  • p. 10 HYPITAT collaborators
    Kennermer Gasthuis, Haarlem

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: the Haarlem hospital's name is Kennemer Gasthuis. The image of p10 shows 'Kennermer Gasthuis'.

Second check: none (judge only)

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Typo Collaborators list: "Albert Schweizer Hospital, Dordrecht" (named after Albert Schweitzer).
  • p. 10 HYPITAT collaborators
    Albert Schweizer Hospital, Dordrecht

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: the Dordrecht hospital is the Albert Schweitzer Ziekenhuis. The image of p10 shows 'Schweizer'.

Second check: none (judge only)

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