From: Appendix I, GRADE tables
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Quality assessment | Definition of outcome | Stage of labour | Total number of women & baby pairs | Measure of diagnostic accuracy (95% CI) | Quality | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Number of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Sensitivity | Specificity | Positive likelihood ratio | Negative likelihood ratio | ||||
Tachycardia (> 150 bpm)(FIGO classification 1987) | |||||||||||||
1 study | Prospective cohort | Very serious1 | No serious inconsistency | No serious indirectness | Serious imprecision2 | Fetal lactacidaemia (lactate > 4.8 mmol/l) | NR; 60 minutes prior to first fetal blood sampling | 1070 |
62.50% (35.87 to 83.72)a |
67.43% (62.21 to 72.26)a |
1.92 (1.28 to 2.89)a |
0.56 (0.29 to 1.05)a | Very low |
1 study | Prospective cohort | Very serious1 | No serious inconsistency | No serious indirectness | Serious imprecision2 | Fetal lactacidaemia (lactate > 4.8 mmol/l) | NR; 60 minutes prior to last fetal blood sampling | 888 |
64.0% (42.6 to 81.3)a |
66.4% (60.4 to 72.0)a |
1.91 (1.36 to 2.67)a |
0.54 (0.32 to 0.92)a | Very low |
Tachycardia (> 160 bpm) (duration not reported) | |||||||||||||
1 study | Case control | Serious3 | No serious inconsistency | No serious indirectness | No serious imprecision | Cerebral palsy | NR | 378 |
28.2% (19.4 to 39)b |
71.7% (66.3 to 76.5)b |
0.99 (0.66 to 1.48)b |
1.0 (0.85 to 1.17)b | Low |
1 study | Cohort | Serious4 | No serious inconsistency | No serious indirectness | No serious imprecision | Umbilical cord arterial pH < 7.20 | NR | 583 |
47.2% (30.9 to 63.5)b |
80.4% (76.9 to 83.87)b |
2.41 (1.63 to 3.55)b |
0.65 (0.48 to 0.89)b | Moderate |
Tachycardia (> 180 bpm) (duration not reported) | |||||||||||||
1 study | Case control | Serious3 | No serious inconsistency | No serious indirectness | No serious imprecision | Cerebral palsy | NR | 378 |
6.4% (2.8 to 14.1)b |
94.7% (91.5 to 96.7)b |
1.20 (0.45 to 3.17)b |
0.98 (0.92 to 1.05)b | Low |
Bradycardia (< 110 bpm) (NICHD classification) (duration not reported) | |||||||||||||
1 study | Case series | Serious5 | No serious inconsistency | No serious indirectness | No serious imprecision | Seizure | 1 hour before birth | 50 |
46.7% (30.2 to 63.9)b |
19.2% (8.5 to 37.9)b |
0.57 (0.37 to 0.88)b |
2.77 (1.17 to 6.52)b | Low |
FHR baseline (< 110 bpm) (NICHD classification) (duration not reported) | |||||||||||||
1 study | Case control | Serious6 | No serious inconsistency | Serious7 | No serious imprecision | Moderate HIE | Last hour of tracing | 214 | 15.4 % | 98.9% | 7.50 | 0.86 | Very low |
Bradycardia (“terminal deceleration”)c | |||||||||||||
1 study | Case control | No serious risk of bias | No serious inconsistency | No serious inconsistency | No serious imprecision | Umbilical cord arterial pH < 7.10 | 30 minutes before birth | 5388 |
21.0% (11.3 to 33.9)b |
82.3% (81.3 to 93.4)b |
1.20 (0.72 to 1.98)b |
0.96 (0.84 to 1.10)b | Low |
Bradycardia (“terminal deceleration”)c | |||||||||||||
1 study | Case control | No serious risk of bias | No serious inconsistency | No serious inconsistency | No serious imprecision | Umbilical cord arterial pH < 7.10 and base excess < −8.0 | 30 minutes before birth | 5388 |
22.0% (11.5 to 36.0)b |
82.3% (81.3 to 83.4)b |
1.25 (0.47 to 2.11)b |
0.95 (0.82 to 1.10)b | Low |
Bradycardia (“terminal deceleration”)c | |||||||||||||
1 study | Case control | No serious risk of bias | No serious inconsistency | No serious inconsistency | No serious imprecision | NICU admission | 30 minutes before birth | 5388 |
06.67% (1.11 to 32.0)b |
82.3% (81.2 to 83.3)b |
0.38 (0.06 to 2.51)b |
1.13 (0.99 to 1.30) | Low |
Prolonged bradycardia (< 110 bpm) (≥ 10 min)d | |||||||||||||
1 study | Case control | No serious risk of bias | No serious inconsistency | No serious inconsistency | No serious imprecision | Umbilical cord arterial pH < 7.10 | 30 minutes before birth | 951 |
33.3% (10.13 to 65.5)b |
97.12% (95.84 to 98.1)b |
11.6 (4.80 to 28.0)b |
0.69 (0.46 to 1.02)b | Low |
Bradycardia (< 100 bpm) (duration not reported) | |||||||||||||
1 study | Case control | Serious3 | No serious inconsistency | No serious indirectness | No serious imprecision | Cerebral palsy | NR | 378 |
34.6% (25 to 45.7)b |
75% (69.8 to 79.6)b |
1.38 (0.96 to 1.99)b |
0.87 (0.73 to 1.03)b | Low |
Mild bradycardia (90 – 119 bpm) (duration not reported) | |||||||||||||
1 study | Cohort | Serious4 | No serious inconsistency | No serious indirectness | No serious imprecision | Umbilical cord arterial pH < 7.20 | 10 minutes before birth | 595 |
61.2% (47.5 to 74.87)b |
75.2% (71.6 to 78.8)b |
2.47 (1.89 to 3.23)b |
0.51 (0.36 to 0.73)b | Very low |
Bradycardia (< 80 bpm) (duration not reported) | |||||||||||||
1 study | Case control | Serious3 | No serious inconsistency | No serious indirectness | No serious imprecision | Cerebral palsy | NR | 378 |
16.7% (10 to 26.5)b |
88.3% (84.2 to 91.5)b |
1.42 (0.79 to 2.56)b |
0.94 (0.84 to 1.05)b | Low |
Moderate/marked bradycardia (60 – 89 bpm) (duration not reported) | |||||||||||||
1 study | Cohort | Serious4 | No serious inconsistency | No serious indirectness | No serious imprecision | Umbilical cord arterial pH < 7.20 | NR | 551 |
63.4% (50.3 to 76.5)b |
82.3% (79 to 85.7)b |
3.59 (2.71 to 4.76)b |
0.44 (0.30 to 0.63)b | Moderate |
Bradycardic episode (<110 bpm as in FIGO classification 1987) | |||||||||||||
1 study | Prospective cohort | Very serious1 | No serious inconsistency | No serious indirectness | Serious imprecision8 | Fetal lactacidaemia (lactate > 4.8 mmol/l) | NR; 60 minutes prior to first fetal blood sampling | 1070 |
62.50 % (35.87 to 83.72)a |
86.76% (82.02 to 90.44)a |
4.72 (2.90 to 7.68)a |
0.43 (0.23 to 0.81)a | Very low |
1 study | Prospective cohort | Very serious1 | No serious inconsistency | No serious indirectness | Serious imprecision8 | Fetal lactacidaemia (lactate > 4.8 mmol/l) | NR; 60 minutes prior to last fetal blood sampling | 888 |
57.1% (34.4 to 77.4)a |
88.1% (82.6 to 92.1)a |
4.81 (2.84 to 8.15)a |
0.49 (0.30 to 0.80)a | Very low |
BPM beats per minute; CI confidence interval; FIGO International Federation of Gynecology and Obstetrics; HIE hypoxic ischaemic encephalopathy; NICHD National Institute of Child Health and Human Development; NICU Neonatal Intensive Care Unit; NR not reported
Calculated by the 2017 NGA technical team
Calculated by the 2014 NCC-WCH technical team
The term ‘terminal deceleration’ used in the paper for this bradycardia defined as a prolonged deceleration (15 bpm or more below baseline for 2 minutes – 10 minutes)
Bradycardia < 10 minutes compared with prolonged bradycardia > 10 minutes
All women in the study had received fetal blood sampling (FBS) therefore may not be representative of the whole population. CTGs were classified by a single observer
Confidence interval for the negative likelihood ratio crosses 0.5
Unclear if assessor was blinded to group allocation. No monitoring traces were available; data were collected from medical notes recorded by physicians who attended the birth
Unclear analysis
Unclear if babies identified as cases were born to women with a low risk pregnancy
Exclusion criteria not specified, high risk of selection bias
Unclear if women with pre-existing medical condition were excluded
Confidence interval for the positive likelihood ratio crosses 5; confidence interval for the negative likelihood ratio crosses 0.5
From: Appendix I, GRADE tables
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.