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. 2016 Oct 3;91(4):1565–1594. doi: 10.1007/s00204-016-1856-y

Table 4.

Results summary for NRT and reproduction/development—birthweight or low birthweight

CAF no.a References Comparisonb Endpoint Casesc Statistic (95 % CI)d
4 Lassen et al. (2010) Birthweight change (g) per week NRT use 0.25 (−2.31 to 2.81)e
8 Gaither et al. (2009) Prescribed/recommended NRT versus not Low birthweight NA 1.49 (0.79 to 2.82)f
10 Wisborg et al. (2000) Nicotine versus placebo patch Birthweight difference (g) 186 (35 to 336)g
Low birthweight 4/11 0.4 (0.1–1.1)i
13 Pollak et al. (2007) Any NRT + CBT versus CBT only Birthweight difference (g) −71 (−283 to 141)h
14 Oncken et al. (2008) Nicotine versus placebo gum Birthweight difference (g) 337 (155 to 519)h
Low birthweight 2/16 0.11 (0.03–0.47)i
15 Swamy et al. (2009) Any NRT + CBT versus CBT only Low birthweight 4/0 4.48 (0.25–81.63)i
16 Coleman et al. (2012b) Nicotine versus placebo patch Low birthweight 56/43 1.38 (0.90–2.09)j
17 El-Mohandes et al. (2013) Nicotine patch + CBT versus CBT only Birthweight difference (g) 206 (−98 to 510)h
Low birthweight 3/4 0.75 (0.19 to 3.03)i
18 Berlin et al. (2014) Nicotine versus placebo patch Birthweight difference (g) 50 (−71 to 172)g
Low birthweight 27/33 0.82 (0.51–1.31)i
Meta-analysis of low birthweight (n = 7) Fixed effect 1.01 (0.78–1.31)
Random effects 0.81 (0.48–1.39)
Heterogeneity p p = 0.01
Weighted analysis of birthweight difference (n = 5) Mean 142 (−53 to 336)
Heterogeneity p p = 0.11

a CAF critical assessment form. CAF 4 is a prospective study, CAF 8 is a cross-sectional study, and the rest are clinical trials

b CBT cognitive behavioural therapy

cExposed/unexposed cases. NA data not available. ‘–’ not applicable

dFor differences in birthweight the mean is shown (exceptionally in one study exposure per week of NRT use), and for low birthweight the odds ratio (OR) or relative risk (RR) as indicated

eBirthweight was noted not to vary significantly by type of NRT used. Also using the Danish National Birth Cohort, Zhu et al. (2014) (CAF 7) reported a clear reduction in birthweight associated with maternal smoking, but no significant reduction associated with NRT use, regardless of whether the father smoked

fAdjusted OR in smokers estimated from data provided

gUnadjusted mean difference

hUnadjusted mean difference estimated from data provided

iUnadjusted RR estimated from data provided

jOR adjusted for recruitment centre