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. 2019 May 1;9(4):e022981. doi: 10.1136/bmjopen-2018-022981

Table 4.

Secondary outcomes: pregnancy outcomes

Treatment (n=95) Sham (n=91) Treatment – sham
Difference (95% CI)
P value
Gestational age at delivery (weeks) 39.0 (38.0 to 39.9) 39.0 (38.0 to 40.4) −0.2* (−0.7 to 0.3) 0.42
OR (95% CI)
Mode of delivery
 Spontaneous vaginal 55 (58%) 43 (47%) 1.5 (0.8 to 2.9) 0.19
 Caesarean section† 40 (42%) 46 (51%) 0.7 (0.4 to 1.3) 0.30
 Vacuum extraction 0 (0%) 2 (2%) 0 (0 to 5.1) 0.24
Sex of newborn
 Male 56 (59%) [2] 43 (47%) [2] 1.6 (0.9 to 3.0) 0.14
Stillbirth 2 (2%) 1 (1%) 1.9 (0.1 to 113) 1
Low birth weight 7 (8%) {12} 6 (7%) {7} 1.2 (0.3 to 4.5) 0.78
Small for gestational age 12 (14%) {12} 20 (24%) {7} 0.5 (0.2 to 1.3) 0.17
Preterm delivery 9 (9%) 10 (11%) 0.8 (0.3 to 2.5) 0.81
Received ≥1 obstetrical diagnosis during labour/delivery 39 (41%) 46 (51%) 0.7 (0.4 to 1.3) 0.24

Count data are presented as frequency (%) and Fisher’s exact test for count data was used to compute the OR.

Square brackets [number] indicate that data is missing for this number of participants.

Curly brackets {number} indicate that this number of participants were excluded from the analysis because their birth weight data were flawed (newborns were weighed on different newborn scales).

*Gestational age at delivery was non-normally distributed, is presented as median (IQR), and Wilcoxon rank sum test was used to test for difference.

†Note: the caesarean section rate at the study site for 2015, 2016 and 2017 was 47%, 47% and 46%, respectively.