Table 2 Crude and adjusted chance/risk of reproductive outcomes based on modified intention to treat criteriaa
Clindamycin/LACTIN-V (N = 94) | Clindamycin/Placebo (N = 88) | Placebo/Placebo (N = 84) | Both active arms versus Placebo/Placebob | |
|---|---|---|---|---|
HCG positives | 57 (61%) 62% (52–71%) | 58 (66%) 65% (56–75%) | 50 (60%) 59% (49–69%) | aRR 1.07 (0.87–1.32) |
Clinical pregnancy week 7–9 | 39 (41%) 42% (32–52%) | 41 (47%) 46% (36–56%) | 38 (45%) 45% (35–56%) | aRR 0.98 (0.74–1.29) |
Ongoing pregnancy week 10–12 | 38 (40%) 41% (31–51%) | 40 (45%) 45% (35–55%) | 37 (44%) 44% (34–54%) | aRR 0.97 (0.73–1.29) |
Early pregnancy loss | 19 (33%) 34% (21–46%) | 18 (31%) 31% (19–43%) | 13 (26%) 26% (14–38%) | aRR 1.24 (0.73–2.11) |
Live birth | 37 (39%) 40% (30–50%) | 40 (45%) 45% (35–55%) | 34 (40%) 40% (30–51%) | aRR 1.05 (0.77–1.42) |
Gemelli | 0 | 0 | 0 | N/A |
Preterm birth <37weeks | 4 (4%) | 2 (2%) | 4 (5%) | c |
Median birth weight (IQR) | 3580 grams (2930–3935) | 3488 grams (3140–3665) | 3813 grams (3220–4035) | c |