Secondary outcomes . | n . | Summary . | Effect (95% CI)‡ . | P . | ||
---|---|---|---|---|---|---|
Placebo . | Probiotic . | Placebo . | Probiotic . | |||
Mother | ||||||
Preeclampsia* | 203 | 206 | 10 (4.9) | 19 (9.2) | 2.00 (0.89–4.50) | 0.09 |
Gestational hypertension* | 203 | 206 | 11 (5.4) | 10 (4.9) | 0.86 (0.35–2.09) | 0.74 |
Hypertensive disorders of pregnancy* | 203 | 206 | 26 (12.8) | 34 (16.5) | 1.35 (0.76–2.37) | 0.30 |
Cesarean* | 204 | 207 | 80 (39.2) | 73 (35.3) | 0.85 (0.56–1.27) | 0.41 |
In labor/intrapartum/emergency caesarean* | 78 | 73 | 36 (46.2) | 33 (45.2) | 1.00 (0.52–1.93) | 1.00 |
Induced labor* | 202 | 206 | 62 (30.7) | 74 (35.9) | 1.23 (0.81–1.87) | 0.34 |
28 weeks systolic BP (mmHg)† | 196 | 197 | 110.3 (10.6) | 110.4 (9.9) | 0.003 (−1.90 to 1.91) | 1.00 |
28 weeks diastolic BP (mmHg)† | 196 | 197 | 65.0 (7.6) | 66.4 (7.8) | 1.36 (−0.11 to 2.84) | 0.070 |
36 weeks systolic BP (mmHg)† | 177 | 169 | 114.0 (10.6) | 115.7 (11.3) | 1.62 (−0.66 to 3.90) | 0.16 |
36 weeks diastolic BP (mmHg)† | 177 | 169 | 70.5 (8.3) | 70.9 (9.8) | 0.51 (−1.35 to 2.37) | 0.59 |
36 weeks weight gain from baseline (kg)† | 176 | 169 | 9.5 (4.3) | 8.9 (5.3) | −0.55 (−1.55 to 0.45) | 0.28 |
Excess weight gain* | 176 | 169 | 81 (46) | 55 (32.5) | 0.56 (0.36–0.87) | 0.01 |
Inadequate weight gain | 28 (15.9) | 34 (20.1) | ||||
Weight gain per week from baseline to 36 weeks (kg/week) | 176 | 169 | 0.40 (0.19) | 0.37 (0.23) | −0.03 (−0.08 to 0.01) | 0.17 |
Infant | ||||||
Gestational age at delivery (weeks) | 180 | 193 | 39.32 (1.75) | 39.14 (1.88) | −0.18 (−0.55 to 0.19) | 0.34 |
Very preterm (<34 weeks)* | 180 | 193 | 3 (1.7) | 5 (2.6) | 1.59 (0.37–6.85) | 0.53 |
Preterm (<37 weeks)* | 180 | 193 | 12 (6.7) | 17 (8.8) | 1.36 (0.63–2.96) | 0.43 |
Special care unit admission* | 199 | 207 | 43 (21.6) | 42 (20.3) | 0.92 (0.57–1.50) | 0.75 |
Jaundice* | 201 | 205 | 40 (19.9) | 35 (17.1) | 0.82 (0.50–1.36) | 0.45 |
Birth injury* | 198 | 203 | 1 (0.5) | 1 (0.5) | — | — |
Hypoglycemia* | 200 | 202 | 27 (13.5) | 25 (12.4) | 0.90 (0.50–1.63) | 0.73 |
Stillbirth* | 204 | 207 | 1 (0.5) | 0 (0.0) | — | — |
Congenital abnormality* | 201 | 204 | 6 (3.0) | 10 (4.9) | 1.70 (0.60–4.80) | 0.32 |
Macrosomia (>4,000 g)* | 203 | 206 | 35 (17.2) | 31 (15.0) | 0.85 (0.50–1.45) | 0.56 |
Macrosomia (>4,500 g)* | 203 | 206 | 2 (1.0) | 7 (3.4) | — | — |
Large for gestational age (>90th percentile)* | 180 | 193 | 30 (16.7) | 35 (18.1) | 1.09 (0.64–1.88) | 0.75 |
SGA (<2,500 g)* | 203 | 206 | 6 (3.0) | 7 (3.4) | 1.15 (0.38–3.50) | 0.81 |
SGA (<10th percentile)* | 199 | 205 | 13 (6.5) | 5 (2.4) | 0.33 (0.12–0.96) | 0.042 |
Birth weight (g)† | 203 | 206 | 3,541 (514) | 3,524 (540) | −15.55 (−118.24 to 87.15) | 0.77 |
Fat-free mass (g)† | 105 | 103 | 3,011 (357) | 3,033 (356) | 21.27 (−76.66 to 119.20) | 0.67 |
Percentage fat† | 105 | 105 | 12.3 (3.6) | 12.2 (4.4) | −0.13 (−1.23 to 0.97) | 0.82 |
Secondary outcomes . | n . | Summary . | Effect (95% CI)‡ . | P . | ||
---|---|---|---|---|---|---|
Placebo . | Probiotic . | Placebo . | Probiotic . | |||
Mother | ||||||
Preeclampsia* | 203 | 206 | 10 (4.9) | 19 (9.2) | 2.00 (0.89–4.50) | 0.09 |
Gestational hypertension* | 203 | 206 | 11 (5.4) | 10 (4.9) | 0.86 (0.35–2.09) | 0.74 |
Hypertensive disorders of pregnancy* | 203 | 206 | 26 (12.8) | 34 (16.5) | 1.35 (0.76–2.37) | 0.30 |
Cesarean* | 204 | 207 | 80 (39.2) | 73 (35.3) | 0.85 (0.56–1.27) | 0.41 |
In labor/intrapartum/emergency caesarean* | 78 | 73 | 36 (46.2) | 33 (45.2) | 1.00 (0.52–1.93) | 1.00 |
Induced labor* | 202 | 206 | 62 (30.7) | 74 (35.9) | 1.23 (0.81–1.87) | 0.34 |
28 weeks systolic BP (mmHg)† | 196 | 197 | 110.3 (10.6) | 110.4 (9.9) | 0.003 (−1.90 to 1.91) | 1.00 |
28 weeks diastolic BP (mmHg)† | 196 | 197 | 65.0 (7.6) | 66.4 (7.8) | 1.36 (−0.11 to 2.84) | 0.070 |
36 weeks systolic BP (mmHg)† | 177 | 169 | 114.0 (10.6) | 115.7 (11.3) | 1.62 (−0.66 to 3.90) | 0.16 |
36 weeks diastolic BP (mmHg)† | 177 | 169 | 70.5 (8.3) | 70.9 (9.8) | 0.51 (−1.35 to 2.37) | 0.59 |
36 weeks weight gain from baseline (kg)† | 176 | 169 | 9.5 (4.3) | 8.9 (5.3) | −0.55 (−1.55 to 0.45) | 0.28 |
Excess weight gain* | 176 | 169 | 81 (46) | 55 (32.5) | 0.56 (0.36–0.87) | 0.01 |
Inadequate weight gain | 28 (15.9) | 34 (20.1) | ||||
Weight gain per week from baseline to 36 weeks (kg/week) | 176 | 169 | 0.40 (0.19) | 0.37 (0.23) | −0.03 (−0.08 to 0.01) | 0.17 |
Infant | ||||||
Gestational age at delivery (weeks) | 180 | 193 | 39.32 (1.75) | 39.14 (1.88) | −0.18 (−0.55 to 0.19) | 0.34 |
Very preterm (<34 weeks)* | 180 | 193 | 3 (1.7) | 5 (2.6) | 1.59 (0.37–6.85) | 0.53 |
Preterm (<37 weeks)* | 180 | 193 | 12 (6.7) | 17 (8.8) | 1.36 (0.63–2.96) | 0.43 |
Special care unit admission* | 199 | 207 | 43 (21.6) | 42 (20.3) | 0.92 (0.57–1.50) | 0.75 |
Jaundice* | 201 | 205 | 40 (19.9) | 35 (17.1) | 0.82 (0.50–1.36) | 0.45 |
Birth injury* | 198 | 203 | 1 (0.5) | 1 (0.5) | — | — |
Hypoglycemia* | 200 | 202 | 27 (13.5) | 25 (12.4) | 0.90 (0.50–1.63) | 0.73 |
Stillbirth* | 204 | 207 | 1 (0.5) | 0 (0.0) | — | — |
Congenital abnormality* | 201 | 204 | 6 (3.0) | 10 (4.9) | 1.70 (0.60–4.80) | 0.32 |
Macrosomia (>4,000 g)* | 203 | 206 | 35 (17.2) | 31 (15.0) | 0.85 (0.50–1.45) | 0.56 |
Macrosomia (>4,500 g)* | 203 | 206 | 2 (1.0) | 7 (3.4) | — | — |
Large for gestational age (>90th percentile)* | 180 | 193 | 30 (16.7) | 35 (18.1) | 1.09 (0.64–1.88) | 0.75 |
SGA (<2,500 g)* | 203 | 206 | 6 (3.0) | 7 (3.4) | 1.15 (0.38–3.50) | 0.81 |
SGA (<10th percentile)* | 199 | 205 | 13 (6.5) | 5 (2.4) | 0.33 (0.12–0.96) | 0.042 |
Birth weight (g)† | 203 | 206 | 3,541 (514) | 3,524 (540) | −15.55 (−118.24 to 87.15) | 0.77 |
Fat-free mass (g)† | 105 | 103 | 3,011 (357) | 3,033 (356) | 21.27 (−76.66 to 119.20) | 0.67 |
Percentage fat† | 105 | 105 | 12.3 (3.6) | 12.2 (4.4) | −0.13 (−1.23 to 0.97) | 0.82 |
*Summary columns: n (%). Effect: odds ratio.
†Summary columns: mean (SD). Effect: difference of means.
‡Adjusted for BMI (25–29, 30–39, and 40+ kg/m2) and patient center (RBWH, Redcliffe, Mater).