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National Guideline Alliance (UK). Evidence review for interventions for chronic hypertension: Hypertension in pregnancy: diagnosis and management: Evidence review A. London: National Institute for Health and Care Excellence (NICE); 2019 Jun. (NICE Guideline, No. 133.)

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Evidence review for interventions for chronic hypertension: Hypertension in pregnancy: diagnosis and management: Evidence review A.

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Table 11Clinical evidence profile. Comparison 7. Labetalol versus methyldopa

Quality assessmentNumber of patientsEffectQualityImportance
Number of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsLabetalolMethyldopaRelative (95% CI)Absolute
Stillbirth
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2no serious imprecisionnone

0/38

(0%)

0/34

(0%)

not calculablenot calculableVERY LOWCRITICAL
Neonatal death
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2very serious3none

2/38

(5.3%)

0/34

(0%)

RR 4.49 (0.22 to 90.30)6-VERY LOWCRITICAL
Small for gestational age
2 (Moore 1982, Sibai 1990)randomised trialsvery serious1no serious inconsistencyserious2very serious3none

20/124

(16.1%)

21/122

(17.2%)

RR 0.89 (0.53 to 1.49)19 fewer per 1000 (from 81 fewer to 84 more)VERY LOWCRITICAL
Birth weight (grams) (Better indicated by higher values)
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2no serious imprecisionnone3834-MD 7 higher (363.32 lower to 377.32 higher)VERY LOWIMPORTANT
Gestational age at birth (weeks) (Better indicated by higher values)
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2no serious imprecisionnone3834-MD 0.1 higher (1.2 lower to 1.4 higher)VERY LOWIMPORTANT
Admission to neonatal unit
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2very serious3none

19/38

(50%)

16/34

(47.1%)

RR 1.06 (0.66 to 1.71)28 more per 1000 (from 160 fewer to 334 more)VERY LOWIMPORTANT
Maximum sBP after entry (mmHg) (Better indicated by lower values)
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2serious4none3834-MD 2.7 higher (5.82 lower to 11.22 higher)VERY LOWCRITICAL
Maximum dBP after entry (mmHg) (Better indicated by lower values)
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2serious5none3834-MD 0.9 lower (5.99 lower to 4.19 higher)VERY LOWCRITICAL
Onset of labour (induction)
1 (Moore 1982)randomised trialsvery serious1no serious inconsistencyserious2very serious3none

20/38

(52.6%)

14/34

(41.2%)

RR 1.28 (0.77 to 2.11)115 more per 1000 (from 95 fewer to 457 more)VERY LOWIMPORTANT
Mode of birth (C-section)
2 (Moore 1982, Sibai 1990)randomised trialsvery serious1no serious inconsistencyserious2very serious3none

49/124

(39.5%)

51/122

(41.8%)

RR 0.93 (0.69 to 1.26)29 fewer per 1000 (from 130 fewer to 109 more)VERY LOWIMPORTANT
1

The quality of the evidence was downgraded by 2 levels due to an unclear risk of random sequence generation, allocation concealment, performance and selection bias, and selective reporting

2

The quality of the evidence was downgraded by 1 level as 34.8% of participants did not present with chronic hypertension

3

The quality of the evidence was downgraded by 2 levels as the 95% CI crossed 2 default MID thresholds (0.8 and 1.25)

4

The quality of the evidence was downgraded by 1 level as the 95% CI crossed 1 MID threshold (14.9 × +/− 0.5 = +/− 7.45)

5

The quality of the evidence was downgraded by 1 level as the 95% CI crossed 1 default MID threshold (9.1 × +/− 0.5 = +/−4.55)

6

The corresponding absolute risk was not calculated as there were no events reported in the control arm.

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