From: Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review
Study | Outcome definition | Design | Intervention/comparison group | WG at vaccination: mean (range) | Tdap-vaccinated group | Control group | Unadjusted estimate (95%CI) | Adjusted estimate (95% CI) | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N | ncases | % | N | ncases | % | |||||||
Fever | ||||||||||||
Hoang et al., 2016 [31] | Self-reported fever without time limit | RCT | Tdap/TT | 25.8 (18–36) | 52 | 1 | 1.9 | 48 | 0 | 0.0 | NR | NR |
Munoz, 2014 [30] | Oral temperature of ≥38° Celsius during 7 days after Tdap vaccination | RCT | Tdap/placebo | 30–32 | 33 | 1 | 3.0 | 15 | 0 | 0.0 | NR | NR |
Maertens et al., 2016 [15] | Fever | PCS | Tdap/no Tdap | 28.6 (22–33) | 57 | 1 | 1.8 | 42 | 0 | 0.0 | NR | NR |
Kharbanda et al., 2016 [39] | Medically attended fever during 3 days after Tdap vaccination | RCS | Tdap/no Tdap | 81.8% ≥20 | 53,885 | 15 | 0.03 | 109,253 | 6 | 0.006 | 2.16 (1.65–2.83)a | NR |
Stillbirth | ||||||||||||
Hoang et al., 2016 [31] | Stillbirth | RCT | Tdap/TT | 25.8 (18–36) | 52 | 0 | 0.0 | 51 | 1 | 2.0 | NR | NR |
Berenson et al., 2016 [33] | Stillbirth | RCS | Tdap/no Tdap | 30.3 (1–40) | 650 | 0 | 0.0 | 1109 | 1 | 0.1 | NR | NR |
Donegan et al., 2014 [36] | Intrauterine death after 24 WG within 14 days of vaccination | RCS | Tdap-IPV/no Tdap | 31 (29–35) | 13,371 | 5 | 0.0 | 13,371 | 7.2 (expected) | 0.1 | 0.69 (0.23–1.62) | NR |
Intrauterine death after 24 WG from vaccination to delivery | 33 (30–36) | 6185 | 12 | 0.2 | 18,523 | 42 | 0.3 | 0.85 (0.44–1.61) | NR | |||
Morgan et al., 2015 [41] | Stillbirth | RCS | Tdap ≥32 WG/no Tdap | ≥32 | 7152 | 25 | 0.3 | 226 | 1 | 0.4 | 0.79 (0.11–5.85)b | NR |
Shakib et al., 2013 [42] | Stillbirth | RCC | Tdap 3–280 days prepartal/no Tdap | 87 (63%) 1st, 24 (17%) 2nd, 27 (20%) 3rd trimester | 138 | 0 | 0.0 | 552 | 5 | 0.9% | 0.36 (0.02–6.54)b | NR |
Neonatal death | ||||||||||||
Morgan et al., 2015 [41] | Not defined | RCS | Tdap ≥32 WG/no Tdap | ≥32 WG | 7152 | 2 | 0.028 | 226 | 0 | 0 | 0.16 (0.01–3.31)b | NR |
Donegan et al., 2014 [36] | Neonatal death within 7 days of delivery | RCS | Tdap-IPV/no Tdap | 33 (30–36) | 6185 | 2 | 0.032 | 18,523 | 6 | 0.032 | 1.00 (0.20–4.95) | NR |
Preterm birth | ||||||||||||
Berenson et al., 2016 [33] | <  37 WG | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 58 | 5.2 | 650 | 59 | 9.1 | 0.77 (0.64–0.93)a | 0.68 (0.45–1.03) |
Kharbanda et al., 2014 [38] | <  37 WG | RCS | Tdap in any WG/no Tdap | 2.014 (7.7%) 1st, 10.936 (41.7%) 2nd, 13.280 (50.6%) 3rd trimester | 26,229 | 1.527 | 6.3 | 97,265 | 7544 | 7.8 | 1.01 (0.95–1.06) | 1.03 (0.97–1.09) |
Tdap 27–36 WG/no Tdap | 11,351 | 602 | 5.3 | 97,265 | 7544 | 7.8 | 0.88 (0.81–0.96) | 0.88 (0.80–0.95) | ||||
Layton et al., 2017 [40] | Not defined; presumably < 37 WG | RCS | Tdap/no Tdap | < 27 | 25,037 | 2.593 | 10.4 | 871,177 | 66,968 | 7.7 | 1.37 (1.32–1.43)a | NR |
≥27 | 123,780 | 6.154 | 5.0 | 871,177 | 66,968 | 7.7 | 0.66 (0.64–0.68)a | NR | ||||
Shakib et al., 2013 [42] | <  37 WG | RCC | Tdap 3–280 days antepartum/no Tdap | 87 (63%) 1st, 24 (17%) 2nd, 27 (20%) 3rd trimester | 134 | 8 | 6.0 | 505 | 38 | 7.5 | 0.78 (0.36–1.71)b | NR |
Munoz et al., 2014 [30] | <  37 WG | RCT | Tdap/placebo | 30–32 | 33 | 3 | 9.1 | 15 | 1 | 6.7 | 1.50 (0.14–15.67)b | NR |
Griffin et al., 2018 [37] | Premature birth ICD-10-AM O60.1.3; birth < 37 WG | RCS | Tdap 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 297 | 3.6 | 60,372 | 2829 | 4.7 | 0.74 (0.66–0.84) | 0.72 (0.63–0.83) |
Morgan et al., 2015 [41] | <  37 WG | RCS | Tdap at ≥32 WG/no Tdap | ≥32 | 7152 | 427 | 5.9 | 226 | 27 | 11.9 | 0.47 (0.31–0.71)b | NR |
Hoang et al., 2016 [31] | Not defined | RCT | Tdap/ TT | 25.8 (18–36) | 52 | 0 | 0.0 | 51 | 1 | 2.0 | NR | NR |
DeSilva et al., 2017 [35] | < 34 WG | RCS | Tdap in any WG/no Tdap | 51% 27–36 | 45,008 | 426 | 0.9 | 152,556 | 2711 | 1.8 | 0.59 (0.54–0.65)a | NR |
Halperin et al., 2018 [32] | MedDRA version 19.0 - definition | RCT | Tdap/Td | 34.5 (32.6–35.6) | 134 | 2 | 1.5 | 138 | 1 | 0.7 | 2.06 (0.19–22.45) | NR |
Low birth weight | ||||||||||||
Berenson et al., 2016 [33] | LBW: < 2500 g | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 61 | 5.5 | 650 | 59 | 9.1 | NR | 0.76 (0.51–1.14) |
VLBW: <  1500 g | 1109 | 2 | 1.1 | 650 | 12 | 0.3 | NR | 0.24 (0.05–1.20) | ||||
Griffin et al., 2018 [37] | Intrauterine growths retardation (ICD10-AM O36.5) | RCS | Tdap 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 401 | 4.9 | 60,372 | 2916 | 4.8 | 0.94 (0.84–1.04) | 0.92 (0.82–1.04) |
Donegan et al., 2014 [36] | Intrauterine growths retardation/LBW < 2500 g | RCS | Tdap-IPV/no Tdap | 33 (30–36) | 6185 | 126 | 2.0 | 18,523 | 311 | 1.7 | 1.20 (0.98–1.48) | NR |
Neonatal sepsis | ||||||||||||
Layton et al., 2017 [40] | Sepsis in the newborn during 30 days after birth | RCS | Tdap/no Tdap | < 27 WG | 16,322 | 394 | 2.41 | 543,906 | 13,187 | 2.27 | 1.07 (0.97–1.18) | 0.89 (0.81–0.99)c 0.91 (0.81–1.02)d |
≥27 WG | 80,217 | 1.774 | 1.84 | 543,906 | 13,187 | 2.27 | 0.81 (0.77–0.85) | 0.83 (0.79–0.88)c 0.89 (0.84–0.94)d | ||||
Admission to newborn intensive care unit | ||||||||||||
Layton et al., 2017 [40] | Admission to newborn intensive care unit during 30 days after birth | RCS | Tdap/no Tdap | < 27 WG | 16,322 | 1.458 | 8.93 | 543,906 | 42,904 | 7.39 | 1.22 (1.16. 1.29) | 0.93 (0.88–0.98)c 0.95 (0.89–.01)d |
≥27 WG | 80,217 | 6996 | 7.25 | 543,906 | 42,904 | 7.39 | 0.98 (0.96–1.01) | 0.97 (0.95–1.00)c 1.00 (0.97–1.03)d | ||||
Berenson et al., 2016 [33] | Not defined | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 103 | 9.3 | 650 | 86 | 13.2 | NR | 0.78 (0.56–1.08) |
Preeclampsia and eclampsia | ||||||||||||
Griffin et al., 2018 [37] | Hypertension (ICD10-AM O13-O16) | RCS | Tdap in 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 262 | 3.2 | 60.372 | 1484 | 2.5 | 1.20 (1.05–1.37) | 1.02 (0.88–1.19) |
Preeclampsia (ICD10-AM O14.09) | 133 | 1.6 | 1007 | 2.5 | 0.91 (0.75–1.09) | 0.85 (0.69–1.04) | ||||||
Severe preeclampsia (ICD10-AM O14.1) | 26 | 0.3 | 271 | 0.4 | 0.67 (0.45–1.00) | 0.61 (0.39–0.94) | ||||||
Layton et al., 2017 [40] | Preeclampsia/eclampsia (642.4x-642.8x)ICD-9 codes 624.xx during 7 days pre- and up to 30 days postpartum | RCS | Tdap/no Tdap | < 27 | 25,037 | 1.096 | 4.38 | 871,177 | 40,930 | 4.4 | 1.00 (0.94–1.06) | 0.99 (0.93–1.05)c 1.05 (0.99–1.12)d |
≥27 | 123,780 | 5.248 | 4.24 | 871,177 | 40,930 | 4.4 | 0.96 (0.94–0.99) | 0.90 (0.87–0.93)c 0.96 (0.94–0.99)d | ||||
Kharbanda et al., 2014 [38] | Gestational hypertension (ICD642.3x). Hypertension in pregnancy (ICD642.9) Preeclampsia or eclampsia (ICD642.4x-642.8x); onset ≥20 WG | RCS | Tdap< 20 WG/no Tdap | 2.014 (7.7%) 1st, 10.936 (41.7%) 2nd, 13.280 (50.6%) 3rd trimester | 6083 | 497 | 8.2 | 97,265 | 7736 | 8.0 | 1.03 (0.94–1.12) | 1.09 (0.99–1.20) |
Donegan et al., 2014 [36] | Not defined; clinical diagnoses during pregnancy from primary care general practice databases | RCS | Tdap-IPV/no Tdap | 33 (30–36) | 6185 | 22 | 0.4 | 18,523 | 54 | 0.3 | 1.22 (0.74–2.01) | NR |
Halperin et al., 2018 [32] | Preeclampsia (MedDRA version 19.0- definition) | RCT | Tdap/Td | 34.5 (32.6–35.6) | 134 | 1 | 0.7 | 138 | 2 | 1.4 | 0.51 (0.05–5.61) | NR |
Maertens et al., 2016 [15] | Preeclampsia | PCS | Tdap/no Tdap | 28.6 (22–33) | 57 | 4 | 7.0 | 41 | 1 | 2.4 | 1.40 (0.88–2.25)a | NR |
Hypertension | 57 | 2 | 3.5 | 41 | 1 | 2.4 | 1.15 (0.51–2.61)a | NR | ||||
Preeclampsia or hypertension | 57 | 6 | 10.5 | 41 | 2 | 4.9 | 1.32 (0.85–2.05)a | NR | ||||
Malformations | ||||||||||||
Hoang et al., 2016 [31] | Not defined. Not reported in results section | RCT | Tdap/TT | 25.8 (18–36) | 52 | 0 | 0.0 | 48 | 0 | 0.0 | NR | NR |
Munoz et al., 2014 [30] | Not defined | RCT | Tdap/placebo | 30–32 | 33 | 1 | 3.0 | 15 | 2 | 13.3 | 0.2 (0.02–2.44)b | NR |
Berenson et al., 2016 [33] | Ten most commonly encountered birth defects reported by the Centers for Disease Control and Prevention | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 18 | 1.6 | 650 | 15 | 2.3 | NR | 0.80 (0.38–1.67) |
DeSilva et al., 2016 [34] | Diagnostic codes for any structural birth defect, diagnosed during first YOL | RCS | Tdap/no Tdap | any WG | 41,654 | 2816 | 6.8 | 282,809 | 17,422 | 6.2 | 1.09 (1.05–1.14) | 0.98 (0.94–1.03) |
27–36 (50%) | 20,568 | 1435 | 7.0 | 120,097 | 8367 | 7.0 | 1.00 (0.95–1.06) | 1.02 (0.96–1.08) | ||||
Diagnostic codes for selected major structural birth defects: such as spina bifida (741.0x and 741.9x); encephalocele, etc., diagnosed during first YOL | any WG | 41,654 | 717 | 1.7 | 282,809 | 4521 | 1.6 | 1.08 (1.00–1.17) | 1.06 (0.98–1.16) | |||
27–36 (50%) | 20,568 | 356 | 1.7 | 120,097 | 1920 | 1.60 | 1.08 (0.97–1.21) | 1.09 (0.97–1.23) | ||||
Diagnostic codes for microcephaly, diagnosed during first YOL | any WG | 41,654 | 38 | 0.09 | 282,809 | 348 | 0.12 | 0.74 (0.53–1.04) | 0.86 (0.60–1.24) | |||
27–36 WG (50%) | 20,568 | 21 | 0.10 | 120,097 | 146 | 0.12 | 0.84 (0.53–1.33) | 1.01 (0.63–1.61) | ||||
Maertens et al., 2016 [15] | Not defined | RCS | Tdap/no Tdap | 28.6 (22–33) | 57 | 0 | 0.0 | 42 | 0 |  | NR | NR |
Morgan et al., 2015 [41] | Major malformations | RCS | Tdap ≥32 WG/no Tdap | ≥32 WG | 7152 | 84 | 1.2 | 226 | 3 | 1.3 | 0.88 (0.28–2.82)b | NR |
Chorioamnionitis | ||||||||||||
Berenson et al., 2016 [33] | Physician’s diagnosis in medical file AND fever ≥38 °C AND ≥1 of the following symptoms: uterine tenderness, malodorous vaginal discharge or maternal leucocytosis | RCS | Tdap in any WG/no Tdap | 30.3 (1–40) | 1.109 | 39 | 3.5 | 650 | 14 | 2.2 | NR | 1.53 (0.80–2.90) |
Kharbanda et al., 2014 [38] | ICD-9 code 658.41 as diagnosis during stay in birth clinic | RCS | Tdap in any WG/no Tdap | 2014 (7.7%) 1st, 10,936 (41.7%) 2nd 13,280 (50.6%) 3rd trimester | 26,229 | 1596 | 6.1 | 97,265 | 5329 | 5.5 | 1.11 (1.05–1.17) | 1.19 (1.13–1.26) |
Tdap during 27–36 WG/no Tdap | 11,351 | 637 | 5.6 | 97,265 | 5329 | 5.5 | 1.02 (0.95–1.11) | 1.11 (1.03–1.21) | ||||
Layton et al., 2017 [40] | ICD-9762.7. 658.4. 658.4x coded for mother or newborn during stay in birth clinic | RCS | Tdap/no Tdap | < 27 | 25,037 | 984 | 3.93 | 871,177 | 25,149 | 2.7 | 1.45 (1.37–1.55) | 1.23 (1.16–1.31)c 1.19 (1.11–1.28)d |
≥27 | 123,780 | 4529 | 3.66 | 871,177 | 25,149 | 2.7 | 1.35 (1.31–1.40) | 1.14 (1.10–1.18)c 1.11 (1.07–1.15)d | ||||
DeSilva et al., 2017 [35] | ICD-9 code 658.41 from maternal medical file during stay in birth clinic | RCS | Tdap at any WG/no Tdap | 51% 27–36 | 45,008 | 2.883 | 6.4 | 152,556 | 7970 | 5.2 | NR | 1.23 (1.17–1.28) |
Tdap during 27–36 WG/no Tdap | 22,772 | 1430 | 6.3 | 133,882 | 7109 | 5.3 | NR | 1.20 (1.14–1.28) | ||||
Griffin et al., 2018 [37] | ICD-10-AM O41.1 | RCS | Tdap during 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 26 | 0.3 | 60,372 | 198 | 0.3 | 0.89 (0.59–1.34) | 1.10 (0.70–1.75) |
Morgan et al., 2015 [41] | Not defined. Extracted from data base with information on pregnancy, birth and newborn | RCS | Tdap ≥32 WG/no Tdap | ≥32 | 7152 | 421 | 5.9 | 226 | 9 | 4.0 | 1.51 (0.77–2.96)b | NR |