Table 3.
Exploratory analysis; Composite outcome of death or survival with abnormal child outcome in the offspring of all randomized women of the ProTWIN trial (all cervical lengths included) and in the subgroup of women with a cervical length <38 mm group, analyzed with generalized linear mixed effects model
| Unselected group | Pessary (n = 815) | Control (n = 829) | OR unadjusted for confounders (95% CI) | NNT or NNH (95% CI) |
|---|---|---|---|---|
| Simple case scenario—composite outcome (%)a | 214 (26.3) | 170 (20.5) | 1.38 (0.94‐2.03) | 18 (10.2‐60.0)b |
| Subgroup CL <38 mm | Pessary (n = 157) | Control (n = 111) | ||
| Simple case scenario—composite outcome (%)a | 29 (18.5) | 40 (36.0) | 0.40 (0.17‐0.96) | 6 (3.5‐14.8)c |
Death or survival with any developmental problem; all deceased children (stillborn, death until 6 wk after the expected term date and death before the age of 4 y) and children with an abnormal score in the ASQ or SDQ total difficulties or a physical problem (≥3 admissions to the hospital or ≥3 surgeries), assuming that the children that were lost to follow‐up were showing the same percentage of disability as the group that was followed‐up.
NNH, number needed to harm.
NNT, number needed to treat.