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Table 2 GRADE Evidence Profile

From: Self-monitoring of blood pressure among women with hypertensive disorders of pregnancy: a systematic review

Certainty assessment

№ of patients

Effect

Certainty

Importance

№ of studies

Study design

Risk of bias

Inconsistency

Indirectness

Imprecision

Other considerations

self-monitoring of blood pressure

clinic blood pressure monitoring

Relative (95% CI)

Absolute (95% CI)

RCT: MATERNAL: Eclampsia or pre-eclampsia (for those without pre-eclampsia prior to entering the study)

MATERNAL: Pre-eclampsia (among pregnant individuals with chronic hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious c,d

none

19/53 (35.8%)

5/30 (16.7%)

RR 2.15 (0.89 to 5.17)

192 more per 1000 (from 18 fewer to 695 more)

⨁⨁◯◯ LOW

CRITICAL

MATERNAL: Pre-eclampsia (among pregnant individuals with gestational hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious c,d

none

15/49 (30.6%)

8/22 (36.4%)

RR 0.84 (0.42 to 1.69)

58 fewer per 1000 (from 211 fewer to 251 more)

⨁⨁◯◯ LOW

CRITICAL

RCT: MATERNAL: C-section

MATERNAL: C-section, total (among pregnant individuals with chronic hypertension) (assessed with: combining emergency pre-labor c-section, emergency c-section in labor, and elective pre-labor c-section)

1 [37]

randomised trials

not serious a

not serious b

not serious

serious d,g

none

39/53 (73.6%)

11/30 (36.7%)

RR 2.01 (1.22 to 3.30)

370 more per 1000 (from 81 more to 843 more)

⨁⨁⨁◯ MODERATE

IMPORTANT

MATERNAL: C-section, total (among pregnant individuals with gestational hypertension) (assessed with: combining emergency pre-labor c-section, emergency c-section in labor, and elective pre-labor c-section)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious c,d,h

none

25/49 (51.0%)

13/22 (59.1%)

RR 0.86 (0.55 to 1.34)

83 fewer per 1000 (from 266 fewer to 201 more)

⨁⨁◯◯ LOW

IMPORTANT

RCT: MATERNAL: Antenatal hospital admission

MATERNAL: Admitted to intensive therapy unit (among pregnant individuals with chronic hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious e

none

0/53 (0.0%)

0/30 (0.0%)

not estimable

⨁⨁◯◯ LOW

CRITICAL

MATERNAL: Admitted to intensive therapy unit (among pregnant individuals with gestational hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

serious f

none

1/49 (2.0%)

0/22 (0.0%)

not estimable

⨁⨁⨁◯ MODERATE

CRITICAL

OBSERVATIONAL: MATERNAL: Adverse pregnancy outcomes: spontaneous abortion, premature rupture of membranes, placental abruption

MATERNAL: Composite maternal adverse outcomes (among pregnant individuals with gestational hypertension) (assessed with: acute renal failure (maternal serum creatinine level > 100 μmol/L antenatally or > 130 μmol/L postnatally) or need for dialysis, acute myocardial ischemia, need for third intravenous agent to control blood pressure (i.e. in addition to labetalol and hydralazine), hypertensive encephalopathy (altered mental status with characteristic cerebral imaging), cortical blindness, retinal detachment, stroke (ischemic or hemorrhagic), pulmonary edema or adult respiratory distress syndrome (defined by characteristic pulmonary imaging in addition to oxygen requirement), need for mechanical ventilatory support (other than for Cesarean section), disseminated intravascular coagulation, thrombotic thrombocytopenic purpura or hemolytic uremic syndrome, acute fatty liver, liver hematoma or rupture, placental abruption, and maternal death)

1 [36]

observational studies

not serious

not serious b

not serious

serious f

none

1/80 (1.3%)

1/63 (1.6%)

RR 0.79 (0.05 to 12.34)

3 fewer per 1000 (from 15 fewer to 180 more)

⨁◯◯◯ VERY LOW

CRITICAL

MATERNAL: Composite maternal adverse outcomes (among pregnant individuals with chronic hypertension, gestational hypertension, or high risk of developing preeclampsia) (assessed with: acute renal failure (maternal serum creatinine level > 100 μmol/L antenatally or > 130 μmol/L postnatally) or need for dialysis, acute myocardial ischemia, need for third intravenous agent to control blood pressure (i.e. in addition to labetalol and hydralazine), hypertensive encephalopathy (altered mental status with characteristic cerebral imaging), cortical blindness, retinal detachment, stroke (ischemic or hemorrhagic), pulmonary edema or adult respiratory distress syndrome (defined by characteristic pulmonary imaging in addition to oxygen requirement), need for mechanical ventilatory support (other than for Cesarean section), disseminated intravascular coagulation, thrombotic thrombocytopenic purpura or hemolytic uremic syndrome, acute fatty liver, liver hematoma or rupture, placental abruption, and maternal death)

1 [38]

observational studies

not serious

not serious b

not serious

serious f

none

1/108 (0.9%)

2/58 (3.4%)

RR 0.27 (0.02 to 2.90)

25 fewer per 1000 (from 34 fewer to 66 more)

⨁◯◯◯ VERY LOW

CRITICAL

RCT: FETAL/NEWBORN: Stillbirth or perinatal death

FETAL/NEWBORN: Stillbirth or neonatal death (among pregnant individuals with chronic hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

serious f

none

3/53 (5.7%)

0/30 (0.0%)

not estimable

⨁⨁⨁◯ MODERATE

CRITICAL

FETAL/NEWBORN: Stillbirth or neonatal death (among pregnant individuals with gestational hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious e

none

0/49 (0.0%)

0/22 (0.0%)

not estimable

⨁⨁◯◯ LOW

CRITICAL

RCT: FETAL/NEWBORN: birthweight / size for gestational age

FETAL/NEWBORN: Birthweight in grams (among pregnant individuals with chronic hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious d,i

none

53

30

MD 300.2 g lower (690.7 lower to 90.2 higher)

⨁⨁◯◯ LOW

CRITICAL

FETAL/NEWBORN: Birthweight in grams (among pregnant individuals with gestational hypertension)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious d,i

none

49

22

MD 54.2 g higher (341.7 lower to 450 higher)

⨁⨁◯◯ LOW

CRITICAL

FETAL/NEWBORN: Small for gestational age (among pregnant individuals with chronic hypertension) (assessed with: birthweight < 10th percentile)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious c,d,j

none

8/53 (15.1%)

1/30 (3.3%)

RR 4.53 (0.59 to 34.48)

118 more per 1000 (from 14 fewer to 1000 more)

⨁⨁◯◯ LOW

CRITICAL

FETAL/NEWBORN: Small for gestational age (among pregnant individuals with gestational hypertension) (assessed with: birthweight < 10th percentile)

1 [37]

randomised trials

not serious a

not serious b

not serious

very serious c,d,k

none

9/49 (18.4%)

4/22 (18.2%)

RR 1.01 (0.35 to 2.93)

2 more per 1000 (from 118 fewer to 351 more)

⨁⨁◯◯ LOW

CRITICAL

  1. CI Confidence interval, RR Risk ratio, MD Mean difference
  2. aRisk of bias: Not downgraded for detection bias. Participant and provider blinding was not possible given the nature of the intervention. Detection bias was unlikely as the outcome unlikely to have been affected by lack of blinding
  3. bInconsistency: This could not be evaluated, as there is only a single study
  4. cImprecision: Downgraded because 95% CI for RR includes both 1 (no effect) AND either appreciable harm (0.75) or appreciable benefit (1.25)
  5. dImprecision: Downgraded for very small sample size
  6. eImprecision: Downgraded twice for non-existent event (in both arms) and very small sample size
  7. fImprecision: Downgraded for very rare event and very small sample size
  8. gPealing et al. 2019 also disaggregates data comparing between SMBP and clinic monitoring for different types of c-section (maternal outcome of interest) among women with chronic hypertension. Number (%) in the SBMP vs Usual care group respectively: elective pre-labor c-section: 15 (28%) vs 4 (13%); emergency c-section in labor: 10 (19%) vs 2 (7%); elective pre-labor c-section: 14 (26%) vs 5 (17%)
  9. hPealing et al. 2019 also disaggregates data comparing between SMBP and clinic monitoring for different types of c-section (maternal outcome of interest) among women with gestational hypertension. Number (%) in the SBMP vs Usual care group respectively: elective pre-labor c-section: 4 (8%) vs 5 (23%); emergency c-section in labor: 11 (22%) vs 1 (4%); elective pre-labor c-section: 9 (18%) vs 3 (14%)
  10. iImprecision: Downgraded because 95% CI for mean difference includes a range of about 800 g (infants are classified as low birthweight at 2500 g)
  11. jPealing et al. 2019 also presents data comparing between SMBP and clinic monitoring for another measure of birthweight (neonatal outcome of interest) among women with chronic hypertension. Number (%) in the SBMP vs Usual care group respectively for birthweight <3rd centile: 2 (4%) vs 1 (3%)
  12. kPealing et al. 2019 also presents data comparing between SMBP and clinic monitoring for another measure of birthweight (neonatal outcome of interest) among women with gestational hypertension. Number (%) in the SBMP vs Usual care group respectively for birthweight <3rd centile: 2 (4%) vs 0 (0%)
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BMC Pregnancy and Childbirth

ISSN: 1471-2393

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