Background
Methods
Data sources and searches
Inclusion and exclusion criteria
Efficacy
-
Pertussis infection (either laboratory confirmed or clinically diagnosed) in infants up to 12 months of age (primary outcome)
-
Severe complications attributed to pertussis (as measured by hospital admissions and/or incidence of pneumonia, seizures, brain damage or death attributed to pertussis) in infants up to 12 months of age
-
Mothers’ and infants’ immune responses (as measured by anti-pertussis antibodies, i.e. pertussis toxin, pertactin, filamentous hemagglutinin and/or fimbriae) in maternal and infant blood at delivery; anti-pertussis antibodies in infant blood prior to the first dose of a pertussis vaccine [at approximately 2 months of age] but after the primary infant vaccination schedule was complete [five to 12 months of age]; or antibodies in breast milk in colostrum and up to 12 months after giving birth)
Safety
-
Adverse vaccine-related outcomes (e.g. incidence of any solicited adverse events including local and systemic reactions) following injections
-
Obstetric or perinatal complications
Data extraction and risk of bias assessment
Data synthesis and analysis
Results
Authors | Country | Setting | Study design | Dates of recruitment | Participants Inclusion (I)/Exclusion (E) | Intervention Exposure | Comparisons | N | Outcomes |
---|---|---|---|---|---|---|---|---|---|
Abu Raya [26] | Israel | Hospital In−/outpatients not specified | PCS | 2013–2014 | I: pregnant women with singleton births at gestational age ≥ 36 weeks E: pregnant women with a newborn <2000 g; immunologic disorder; immunoglobulins in the previous year; immunosuppressive drugs in the current pregnancy; pertussis infection or pertussis-containing vaccine within 5 years or any vaccine besides Tdap within 2 weeks of delivery. | Tdap ≥20 weeks’ gestation | No Tdap during pregnancy | 81 | Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA |
Abu Raya [27] | Israel | Same as above | PCS | 2013–2014 | I: pregnant women with singleton births; gestational age ≥ 36 weeks; intending to breast feedE: same as Abu Raya et al. [26] | Tdap ≥20 weeks’ gestation | No Tdap during pregnancy | 37 | Anti-pertussis antibodies in breast milk measured by ELISA |
Dabrera [37] | UK | Community- based data | CCS | 2012–2013 | E: any potentially confounding protective effect from active immunisation. | Any pertussis-containing vaccine at any time in pregnancy | No pertussis-containing vaccine during pregnancy | 113 | Pertussis infection in infants; pertussis related complications as measured by the length of hospital stay in infants |
De Schutter [28] | Belgium | Hospitals In−/outpatients not specified | PCS | 2013–2014 | E: Women who delivered prematurely, who had received another vaccine or any blood product in the previous month. | Tdap during the 2nd or 3rd trimester | No Tdap during pregnancya
| 28a
| Anti-pertussis antibodies in breast milk measured by ELISA |
Donegan [32] | UK | Community- based data | RCS | 2012–2013 for vaccine group/ 2010–2012 for control group | I: women aged ≥12 who had a pertussis-containing vaccination during pregnancy and at least 28 days of follow-up data after vaccination | Any pertussis vaccine at any time during pregnancy | No pertussis-containing vaccine during pregnancy | 38,900 | Obstetric and perinatal complications |
Gall [5] | US | Hospital In−/outpatients not specified | RCS | 2008–2009 | I: pregnant women who had been admitted to the hospital at the study site and their babies | Tdap at any time during pregnancyb
| No Tdap during pregnancy | 104 | Anti-pertussis antibodies in infants’ sera measured by ELISA |
Hardy-Fairbanks [33] | Not specifiedc
| Not specifiedb
| PCS | 2006 for vaccine group/ 2008–2009 for control group | E: Women with multiple gestations; serious underlying health issues in either the mother or infant, preterm infants, or infants who needed transfusions or who had been advised not to have blood drawn for health reasons | Tdap at any time during pregnancy | No Tdap during pregnancy | 70 | Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA |
Healy [34] | US | Hospital In−/outpatients not specified | RCS | 2009–2011 | I: Women who delivered at ≥37 weeks’ gestation; received Tdap within 2 years; and had plasma–serum pairs available | Tdap at any time during pregnancy | Tdap before pregnancy | 105 | Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA |
Hoang [30] | Vietnam | Community | RCT | 2012–2013 | I: Women aged 18–41 with low risk for complications.E: Women with: any serious underlying medical condition; febrile illness in the 72 h before injection, receipt of TT vaccine in the past month; receipt of Tdap in the past 10 years; receipt of a vaccine, blood product or experimental medicine in the 4 weeks before or after injection; previous severe reaction to any vaccine | Tdap, 20–30 weeks’ gestation | TT during pregnancy | 103 | Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA; vaccine-related adverse outcomes; obstetric and perinatal complications. |
Kharbanda [24] | US | Community- based data | RCS | 2010–2012 | I: Women with singleton pregnancies with a live birth E: women with live virus vaccines during pregnancy; Tdap in the 7 days after the estimated pregnancy start date or in the 7 days before delivery; incomplete birth data | Tdap at any time during pregnancyd
| No Tdap during pregnancy | 123,494 | Obstetric and perinatal complications |
Kharbanda [25] | US | Community- based data | RCS | 2007–2013 | Same as Kharbanda et al. [24] | Tdap at any time during pregnancyd
| No Tdap during pregnancy | 163,138 | Obstetric complications occurring within 42 days of vaccination. |
Ladhani [35] | UK | Community- based data | RCS | 2012–2014 for vaccine group/ 2011–2012 for control group | I: Any infant eligible for the national immunisation program | Tdap-IPV | No pertussis -containing vaccine during pregnancy | 387 | Antibody responses after primary immunisation in infants’ sera measured by ELISA. |
Maertens [29] | Belgium | Hospitals In−/outpatients not specified | PCS | 2012–2014 | I: Women aged 18–40 with low risk for complications. E: same as Hoang et al. [30] | Tdap at 22–33 weeks’ gestation | No pertussis-containing vaccine during pregnancy | 99 | Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA; obstetric complications |
Munoz [31] | US | NIH Vaccine Treatment Evaluation Unit | RCT | 2008–2012 | I: Women aged 18–45 with no underlying chronic medical conditions, a singleton, uncomplicated pregnancy with normal first- or second-trimester screening test results E: Women who received Tdap or any tetanus-containing vaccine within the prior 2 years | Tdap at 30–32 weeks’ gestation | Placebo | 45 | Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA; vaccine-related adverse outcomes; perinatal complications; pertussis infection in infants |
Shakib [36] | US | Healthcare database | RCS | 2005–2009 | I: Pregnant women 12–45 years of age and their babies E: Women who had documentation of Tdap vaccine within 3 days prior to the delivery outcome | Tdap at any time during pregnancy | No Tdap during pregnancy | 690 | Pertussis infection in infants; perinatal complications |
Intervention/exposure and comparison
Risk of bias in included studies
RCT
Cohort studies
Case-control study
Efficacy
Pertussis infection
Severe complications attributed to pertussis
Mothers’ and infants’ immune response to vaccine
Study design | Intervention/ exposuretype, mean gestational week at vaccination (range) | Com-parator | Maternal blood birth | Infant cord blood at birth | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n: Vaccine/control | Vaccine Geometric mean (95% CI) | Control Geometric mean (95% CI) | Ratio of geometric means (95% CI) | p | n: Vaccine/control | Vaccine Geometric mean (95% CI) | Control Geometric mean (95% CI) | Ratio of geometric means (95% CI) | p | ||||
PT (EU or IU/ml)* | |||||||||||||
Munoz [31] | RCT | Tdap -- (30–32) | placebo | 33/14 | 51.0 (37.1–70.1) | 9.1 (4.6–17.8) | 5.6 (3.0–10.5) | <0.001 | 31/14 | 68.8 (52.1–90.8) | 14.0 (7.3–26.9) | 4.9 (2.8–8.7) | <0.001 |
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 51/47 | 17.3 (13.0–22.0) | 5.7 (4.3–7.6) | 3.0 (2.1–4.4) | <0.001 | 50/47 | 21.0 (16.0–28.0) | 7.2 (5.6–9.4) | 2.9 (2.0–4.3) | <0.001 |
Abu Raya [26] | PCS | Tdap -- (≥ 20) | no vac. | 61/20 | 16.9 (10.5–27.0) | 0.7 (0.3–1.8) | 22.8 (8.8–58.7) | <0.001 | 61/20 | 17.81 (10.67–29.74) | 1.12 (0.41–3.02) | 15.9 (5.6–45.1) | <0.001 |
(subset)
|
(27–36)
|
51/20
|
16.4 (9.6–28.0)
|
0.7 (0.3–1.8)
|
22.1 (8.1–60.0)
|
<0.001
|
51/20
|
17.3 (9.5–31.5)
|
1.12 (0.4–3.0)
|
15.4 (5.0–47.6)
|
<0.001
| ||
(subset)
|
(≥ 37)
|
7/20
|
28.1 (12.5–63.4)
|
0.7 (0.3–1.8)
|
38.0 (8.2–174.9)
|
<0.001
|
7/20
|
21.12 (7.9–56.2)
|
1.12 (0.4–3.0)
|
18.9 (3.3–108.1)
|
<0.001
| ||
Hardy-Fairbanks [33] | PCS | Tdap – (anytime) | no vac. | 5/53 | 14.3 (−-) | 7.5 (−-) | 1.9 (−-) | – | 5/53 | 33.5 (−-) | 12.6 (−-) | 2.7 (−-) | – |
Maertens [29] | PCS | Tdap 29 (22–33) | no vac. | 56/41 | 31.4 (26.0–38.0) | 6.4 (4.3–9.6) | 4.9 (3.3–7.3) | <0.001 | 58/41 | 100.7 (82.0–123.0) | 12.4 (8.0–19.0) | 8.1 (5.3–12.5) | <0.001 |
Healy [34] | RCS | Tdap 9 (1–29) | before | 19/86 | 10.5 (6.4–17.1) | 14.0 (11.1–17.7) | 0.8 (0.4–1.3) | 0.29 | 19/86 | 17.3 (11.1–26.8) | 16.7 (13.2–21.0) | 1.0 (0.6–1.8) | 0.90 |
Gall [5] | RCS | Tdap -- (anytime) | no vac. | 52/52 | Mean 28.2 (SE 2.8) | Mean 11.01 (SE 1.8) | MD 17.2 (10.7–23.8) | ||||||
FHA (EU or IU/ml) | |||||||||||||
Munoz [31] | RCT | Tdap -- (30–32) | placebo | 33/14 | 184.8 (142.8–239.1) | 21.9 (10.9–44.1) | 8.4 (4.8–15.0) | <0.001 | 31/14 | 234.2 (184.6–297.3) | 25.1 (10.5–60.3) | 9.3 (4.9–17.6) | <0.001 |
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 49/47 | 139.0 (109.0–176.0) | 17.3 (14.0–21.4) | 8.0 (5.8–11.0) | <0.001 | 49/46 | 93.0 (65.0–133.0) | 27.3 (20.9–36.7) | 3.4 (2.2–5.4) | <0.001 |
Abu Raya [26] | PCS | Tdap -- (≥ 20) | no vac. | 61/20 | 187.4 (162.9–215.7) | 13.4 (8.9–20.3) | 14.0 (10.0–19.4) | <0.001 | 61/20 | 190.2 (160.9–224.8) | 17.1 (10.2–28.7) | 11.1 (7.4–16.6) | <0.001 |
(subset)
|
(27–36)
|
51/20
|
192.0 (165.9–222.3)
|
13.4 (8.9–20.3)
|
14.3 (10.2–20.0)
|
<0.001
|
51/20
|
196.7 (163.4–236.9)
|
17.1 (10.2–28.7)
|
11.5 (7.5–17.6)
|
<0.001
| ||
(subset)
|
(≥ 37)
|
7/20
|
155.8 (109.3–222.2)
|
13.4 (8.9–20.3)
|
11.6 (5.7–23.7)
|
<0.001
|
7/20
|
138.0 (97.6–195.2)
|
17.1 (10.2–28.7)
|
8.1 (3.3–19.5)
|
<0.001
| ||
Hardy-Fairbanks [33] | PCS | Tdap – (anytime) | no vac. | 5/53 | 32.5 (−-) | 9.6 (−-) | 3.4 (−-) | – | 5/53 | 66.1 (−-) | 15.9 (−-) | 4.2 (−-) | – |
Maertens [29] | PCS | Tdap 29 (22–33) | no vac. | 56/41 | 107.0 (91.0–126.0) | 21.4 (16.6–27.5) | 5.0 (3.8–6.6) | <0.001 | 58/41 | 140.0 (109.0–180.0) | 27.5 (21.5–35.0) | 5.1 (3.6–7.3) | <0.001 |
Healy [34] | RCS | Tdap 9 (1–29) | before | 19/86 | 49.3 (28.4–85.8) | 50.9 (40.6–63.9) | 1.0 (0.6–1.7) | 0.91 | 19/86 | 87.6 (56.3–136.4) | 73.0 (57.6–92.6) | 1.2 (0.7–2.1) | 0.51 |
Gall [5] | RCS | Tdap -- (anytime) | no vac. | 52/52 | Mean 104.2 (SE 21.7) | Mean 26.8 (SE 4.0) | MD 77.3 (33.6–121.0) | <0.001 | |||||
PRN (EU or IU/ml) | |||||||||||||
Munoz [31] | RCT | Tdap -- (30–32) | placebo | 45/35 | 184.5 (110.2–308.8) | 12.2 (5.2–28.4) | 15.1 (5.9–38.6) | <0.001 | 35/35 | 219.0 (134.4–357.0) | 14.4 (5.4–38.4) | 15.2 (5.9–39.3) | <0.001 |
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 49/48 | 111.0 (76.0–163.0) | 9.4 (6.9–12.5) | 11.8 (7.3–19.1) | <0.001 | 49/47 | 124 (86–179) | 13.9 (10.5–18.2) | 8.9 (5.6–14.1) | <0.001 |
Abu Raya [26] | PCS | Tdap -- (≥ 20) | no vac. | 61/20 | 166.0 (125.7–219.4) | 8.5 (3.5–20.3) | 19.6 (10.0–38.6) | <0.001 | 61/20 | 162.1 (120.4–218.2) | 10.6 (4.5–25.3) | 15.3 (7.6–30.7) | <0.001 |
(subset)
|
(27–36)
|
51/20
|
164.0 (119.5–225.1)
|
8.5 (3.5–20.3)
|
19.4 (9.4–39.9)
|
<0.001
|
51/20
|
161.5 (114.7–227.5)
|
10.6 (4.5–25.3)
|
15.2 (7.2–32.1)
|
<0.001
| ||
(subset)
|
(≥ 37)
|
7/20
|
181.6 (65.5–503.0)
|
8.5 (3.5–20.3)
|
21.5 (4.5–101.4)
|
<0.001
|
7/20
|
172.9 (68.7–434.8)
|
10.6 (4.5–25.3)
|
16.3 (3.5–75.0)
|
<0.001
| ||
Hardy-Fairbanks [33] | PCS | Tdap -- (anytime) | no vac. | 5/53 | 24.4 (−-) | 6.4 (−-) | 3.8 (−-) | – | 5/53 | 48.5 (−-) | 8.9 (−-) | 5.5 (−-) | – |
Maertens [29] | PCS | Tdap 29 (22–33) | no vac. | 57/41 | 602.0 (485.5–747.0) | 18.0 (13.0–24.0) | 33.4 (23.4–47.9) | <0.001 | 57/41 | 697.0 (573.0–848.0) | 21.0 (15.5–28.0) | 33.2 (23.7–46.5) | <0.001 |
Healy [34] | RCS | Tdap 9 (1–29) | before | 19/86 | 40.4 (18.9–87.3) | 39.5 (28.3–55.0) | 1.0 (0.5–2.2) | 0.96 | 19/86 | 70 (32.5–150.5) | 41.7 (81.6–4.07) | 1.2 (0.5–2.6) | 0.65 |
Gall [5] | RCS | Tdap -- (anytime) | no vac. | 52/52 | Mean 333.0 (SE 56.4) | Mean 24.7 (SE 5.8) | MD 308.3(195.8–420.0) | <0.001 | |||||
FIM (EU or IU/ml) | |||||||||||||
Munoz [31] | RCT | Tdap -- (30–32) | no vac. | 11/38 | 1485.7 (979.9–2252.6) | 34.9 (16.3–74.8) | 42.6 (19.5–93.1) | <0.001 | 15/32 | 1867.0 (1211.7–2876.8) | 51.8 (22.8–118) | 36.0 (15.8–82.1) | <0.001 |
Hardy-Fairbanks [33] | PCS | Tdap -- (anytime) | no vac. | 5/53 | 360.3 (−-) | 17.7 (−-) | 20.4 (−-) | – | 5/53 | 912.9 (−-) | 25.7 (−-) | 35.5 (−-) | – |
Healy [34] | RCS | Tdap 9 (1–29) | before | 11/38 | 103.1 (42.7–249.0) | 138.2 (97.2–196.5) | 0.7 (0.3–1.7) | 0.49 | 15/32 | 191.8 (84.5–435.7) | 182.6 (127.7–261.2) | 1.1 (0.5–2.4) | 0.91 |
Gall [5] | RCS | Tdap -- (anytime) | no vac. | 51/26 | 49/21 | Mean 11,989.0 (SE 189.9) | Mean 82.8 (SE 14.59) | MD 1116.2 (738.3–1494.0) | <0.001 |
Study design | Intervention/ exposure type, mean gestational week at vaccination (range) | Com-parator | Infant blood at 2 months of age (before primary vaccination) | Infant blood at 5 months of age (after primary vaccination | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n: Vaccine /control | Vaccine Geometric mean (95% CI) | Control Geometric mean (95% CI) | Ratio of geometric means (95% CI) | p | n: Vaccine /control | Vaccine Geometric mean (95% CI) | Control Geometric mean (95% CI) | Ratio of geometric means (95% CI) | p | ||||
PT (EU or IU/ml)* | |||||||||||||
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 45/35 | 4.2 (2.9–5.9) | 0.8 (0.5–1.3) | 5.3 (3.0–9.3) | <0.001 | 35/35 | 70 (58–84) | 67 (53–84) | 1.0 (0.8–1.4) | 0.76 |
Hardy-Fairbanks [33] | PCS | Tdap -- (anytime) | no vac. | 11/38 | 15.4 (−-) | 4.8 (−-) | 3.2 (−-) | 15/32 | 56.8 (−-) | 75.2 (−-) | 0.8 (−-) | – | |
Maertens [29] | PCS | Tdap 29 (22–33) | no vac. | 51/26 | 15.5 (12.1–20) | 1.1 (0.7–1.6) | 14.1 (9.0–22.1) | <0.001 | 49/21 | 29 (25–35) | 54 (42–69) | 0.5 (0.4–0.7) | <0.001 |
Ladhani [35] | RCS | TdaP/IPV -- (−-) | no vac. | 129/203 | 28.8 (25.7–32.4) | 43.2 (39.4–47.2) | 0.7 (0.6–0.8) | <0.001 | |||||
FHA (EU or IU /ml) | |||||||||||||
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 45/35 | 59 (48–73) | 23.1 (19.7–27) | 2.6 (1.9–3.4) | <0.001 | 35/35 | 77 (66–90) | 66.6 (56–78) | 1.2 (0.9–1.4) | 0.20 |
Hardy-Fairbanks [33] | PCS | Tdap -- (anytime) | no vac. | 11/38 | 41.6 (−-) | 5.6 (−-) | 7.4 (−-) | – | 15/32 | 61.4 (−-) | 83.6 (−-) | 0.7 (−-) | – |
Maertens [29] | PCS | Tdap 29 (22–33) | no vac. | 51/26 | 121 (100–145) | 23 (19–27) | 5.3 (4.0–7.0) | <0.001 | 49/21 | 65 (56–75) | 54 (41–70) | 1.2 (0.9–1.6) | 0.19 |
Ladhani [35] | RCS | TdaP/IPV -- (−-) | no vac. | 131/199 | 25.5 (23.0–28.3) | 41.1 (37.5–45.1) | 0.4 (0.2–0.6) | <0.001 | |||||
PRN (EU or IU /ml) | |||||||||||||
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 45/35 | 46 (32–66) | 7.8 (6.6–9.4) | 5.9 (3.8–9.1) | <0.001 | 35/35 | 83 (65–104) | 132.6 (104–168) | 0.6 (0.5–0.9) | 0.006 |
Hardy-Fairbanks [33] | PCS | Tdap -- (anytime) | no vac. | 11/38 | 32.1 (−-) | 3.9 (−-) | 8.2 (−-) | – | 15/32 | 34.1 (−-) | 50.7 (−-) | 0.7 (−-) | – |
Maertens [29] | PCS | Tdap 29 (22–33) | no vac. | 51/26 | 253 (183–351) | 17 (14.5–21) | 14.9 (9.3–23.8) | <0.001 | 49/21 | 68 (56–84) | 87 (62–121) | 1.2 (0.9–23.8) | 0.19 |
FIM (EU or IU /ml) | |||||||||||||
Hardy-Fairbanks [33] | PCS | Tdap -- (anytime) | no vac. | 11/38 | 296.4 (−-) | 13.0 (−-) | 22.8 (−-) | – | 15/32 | 15.0 (−-) | 10.0 (−-) | 1.5 (−-) | – |
Ladhani [35] | RCS | TdaP/IPV -- (−-) | no vac. | 130/197 | 113.9 (99.0–131.1) | 224.9 (196.1–258.0) | 0.5 (0.2–1,3) | 0.16 |
Safety
Vaccine-related adverse outcomes
Study design | Intervention/exposure type, mean gestational week at vaccination (range) | Compara-tor | Vaccine group | Control group | Crude RR (95% CI) | Adjusted RR (95% CI) | |||
---|---|---|---|---|---|---|---|---|---|
Event n. (%) | N | Event n. (%) | N | ||||||
ADVERSE EVENTS (AE) | |||||||||
Any solicited adverse events | |||||||||
Hoang [30]a
| RCT | Tdap 26 (19–35) | TT | 23 (44.2) | 52 | 22 (43.1) | 51 | 1.0 (0.7–1.6) | |
Munoz [31]b
| RCT | Tdap -- (30–32) | placebo | 26 (78.8) | 33 | 5 (33.3) | 15 | 2.4 (1.1–4.9) | |
Any injection site reactions
|
26 (78.8)
|
33
|
3 (20.0)
|
15
|
3.9 (1.4–11.0)
| ||||
(pain)
|
25 (75.8)
|
33
|
2 (13.3)
|
15
|
5.7 (1.5–20.9)
| ||||
(erythema/redness)
|
3 (9.1)
|
33
|
1 (6.7)
|
15
|
1.4 (0.2–12.1)
| ||||
(induration/swelling)
|
3 (9.1)
|
33
|
0 (0)
|
15
| NAc
| ||||
Any systemic symptoms
|
12 (36.4)
|
33
|
3 (20.0)
|
15
|
1.8 (0.6–5.5)
| ||||
(fever)
|
1 (3.0)
|
33
|
0 (0)
|
15
| NAc
| ||||
(headache)
|
11 (33.3)
|
33
|
3 (20.0)
|
15
|
1.7 (0.5–5.1)
| ||||
(malaise)
|
4 (12.1)
|
33
|
2 (13.3)
|
15
|
0.9 (0.2–4.4)
| ||||
(myalgia)
|
5 (15.2)
|
33
|
0 (0)
|
15
| NAc
| ||||
OBSTETRIC COMPLICATIONS | |||||||||
Hypertensive disorders | |||||||||
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 22 (0.4) | 6185 | 54 (0.3) | 18,523 | 1.2 (0.7–2.0) | |
Kharbanda [24] | RCS | Tdap, before 20 | no vaccine | 497 (8.2) | 6083 | 7736 (8.0) | 97,265 | 1.0 (0.9–1.1) | 1.1 (1.0–1.2)e
|
Maertens [29]d
| PCS | Tdap 29 (22–33) | no vaccine | 6 (10.5) | 57 | 2 (4.9) | 41 | 2.2 (0.5–10.2) | |
Premature contraction | |||||||||
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 2 (3.8) | 52 | 1 (2.0) | 51 | 2.0 (0.2–21.0) | |
Maertens [29] | PCS | Tdap 29 (22–33) | no vaccine | 4 (7.0) | 57 | 0 (0) | 41 | NAc
| |
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 5 (0.1) | 6185 | 21 (0.1) | 18,523 | 0.7 (0.3–1.9) | |
Chorioamnionitis | |||||||||
Kharbanda [24] | RCS | Tdap -- (anytime) | no vaccine | 1596 (6.1) | 26,229 | 5329 (5.5) | 97,265 | 1.11 (1.05–1.17) | 1.2 (1.13–1.3)e
|
(subset)
|
Tdap, 27–36
|
637 (0.1)
|
11,351
|
5329 (0.1)
|
97,265
|
1.02 (0.95–1.11)
|
1.1 (1.0–1.2)
e
| ||
Proteinuria | |||||||||
Kharbanda [25]f
| RCS | Tdap -- (anytime) | no vaccine | 84 (0.2) | 53,885 | 207 (0.2) | 109,253 | 0.8 (0.6–1.1) | 0.8 (0.6–1.1)g
|
Caesarean section | |||||||||
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 1238 (20.0) | 6185 | 3748 (20.2) | 18,523 | 1.0 (0.9–1.0) | |
Postpartum haemorrhage | |||||||||
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 59 (1.0) | 6185 | 181 (1.0) | 18,523 | 1.0 (0.7–1.3) | |
Venous thromboembolism | |||||||||
Kharbanda [25]f
| RCS | Tdap -- (anytime) | no vaccine | 22 (0.04) | 53,885 | 69 (0.1) | 109,253 | 0.6 (0.4–1.0) | 0.7 (0.4–1.1)g
|
Thrombocytopenia | |||||||||
Kharbanda [25]f
| RCS | Tdap, ≥ 20 | no vaccine | 249 (0.1) | 44,063 | 579 (0.1) | 86,057 | 0.8 (0.7–1.0) | 0.9 (0.7–1.0)g
|
Gestational diabetes | |||||||||
Kharbanda [25]f
| RCS | Tdap, ≥ 20 | no vaccine | 1101 (2.5) | 44,063 | 2263 (2.6) | 86,057 | 1.0 (0.9–1.0) | 1.0 (0.9–1.0)g
|
Cardiac events | |||||||||
Kharbanda [25]f
| RCS | Tdap, ≥ 20 | no vaccine | 90 (0.2) | 44,063 | 198 (0.2) | 86,057 | 0.9 (0.7–1.1) | 0.9 (0.7–1.2)g
|
Oligohydramnios | |||||||||
Maertens [29] | PCS | Tdap 29 (22–33) | no Tdap | 1 (1.8) | 57 | 0 (0) | 41 | NAc
| |
Placenta praevia | |||||||||
Maertens [29] | PCS | Tdap 29 wks (22–33) | no vaccine | 0 (0) | 57 | 1 (2.44) | 41 | 0 (NA)c
| |
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 2 (< 0.1) | 6185 | 15 (0.1) | 18,523 | 0.4 (0.1–1.7) | |
PERINATAL COMPLICATIONS | |||||||||
Stillbirth | |||||||||
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 0 (0) | 52 | 1 (2.0) | 51 | 0 (NA)c
| |
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 12 (0.2) | 6185 | 42 (0.2) | 18,523 | 0.9 (0.5–1.6) | |
Shakib [36] | RCS | Tdap -- (anytime) | no vaccine | 0 (0) | 138 | 5 (0.9) | 552 | 0 (NA)c
| |
Neonatal death | |||||||||
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 2 (<0.1) | 6185 | 6 (<0.1) | 18,523 | 1.0 (0.2–4.9) | |
Preterm births | |||||||||
Munoz [31] | RCT | Tdap -- (30–32) | no vaccine | 3 (9.1) | 33 | 1 (6.7) | 15 | 1.4 (0.2–12.1) | |
Hoang [30] | RCT | Tdap 26 (19–35) | TT | 0 (0) | 52 | 1 (2.0) | 51 | 0 (NA)c
| |
Kharbanda [24] | RCS | Tdap -- (anytime) | no vaccine | 1527 (5.8) | 26,229 | 7544 (7.8) | 97,265 | 0.8 (0.7–0.8)h
| 1.0 (1.0–1.1)e
|
Shakib [36] | RCS | Tdap -- (anytime) | no vaccine | 8 (6.0) | 134 | 38 (7.5) | 505 | 0.8 (0.4–1.7) | |
SGA (<10th percentile) | |||||||||
Kharbanda [24] | RCS | Tdap -- (anytime) | no vaccine | 2214 (8.4) | 26,229 | 8086 (8.3) | 97,265 | 1.0 (1.0–1.0) | 1.0 (1.0–1.1)e
|
Low birth weight (< 2500 g) | |||||||||
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | 126 (2.0) | 6185 | 311 (1.7) | 18,523 | 1.2 (1.0–1.5) | |
Birth weight (kg) | |||||||||
Munoz [29] | RCT | Tdap -- (30–32) | placebo | Mean 3.2 (SD 0.5) | 33 | Mean 3.5 (SD 0.7) | 15 | MD −0.3 (−0.7–0.1) | |
Donegan [32] | RCS | Any pertussis vaccine--(anytime) | no vaccine | Median 3.5 | 6185 | Median 3.5 | 18,523 | Median difference 0 | |
Apgar scores 1 min | |||||||||
Munoz [31] | RCT | Tdap -- (30–32) | no vaccine | Mean 8.0 (SD 1.4) | 33 | Mean 7.9 (SD 1.1) | 15 | MD 0.1(−0.07–0.9) | |
Apgar scores 5 min | |||||||||
Munoz [31] | RCT | Tdap -- (30–32) | no vaccine | Mean 8.9 (SD 0.2) | 33 | Mean 8.9 (SD 0.4) | 15 | MD 0 (−0.2–0.2) | |
Abnormal conditions | |||||||||
Munoz [31] | RCT | Tdap -- (30–32) | no vaccine | 3 (9.1)i
| 33 | 3 (20.0)j
| 15 | 0.5 (0.1–2.0) | |
Congenital anomalies | |||||||||
Munoz [31] | RCT | Tdap -- (30–32) | no vaccine | 1 (3.0)k
| 33 | 2 (13.3)l
| 15 | 0.2 (0.0–2.3) |