Table 3.
Prespecified subgroup analyses based on baseline risk factors in women entered into the treatment phase of the OPPTIMUM study
|
Treatment effect |
pinteraction | |||||
|---|---|---|---|---|---|---|
| OR or mean difference (95% CI); p value | N | OR or mean difference (95% CI); p value | N | |||
| Fibronectin status | Negative | Negative | Positive | Positive | ||
| Obstetric outcome | 0·88 (0·58 to 1·33); 0·542 | 859 | 0·91 (0·57 to 1·46); 0·707 | 338 | 0·91 | |
| Neonatal outcome | 0·65 (0·37 to 1·13); 0·129 | 847 | 0·64 (0·34 to 1·20); 0·162 | 329 | 0·96 | |
| Childhood outcome | −0·63* (−3·28 to 2·03); 0·644 | 628 | −1·09* (−5·41 to 3·23); 0·612 | 241 | 0·86 | |
| Cervical length at baseline | >25 mm | >25 mm | ≤25 mm | ≤25 mm | ||
| Obstetric outcome | 0·88 (0·50 to 1·57); 0·672 | 445 | 0·69 (0·39 to 1·20); 0·191 | 251 | 0·54 | |
| Neonatal outcome | 0·74 (0·35 to 1·56); 0·432 | 436 | 0·54 (0·25 to 1·16); 0·113 | 246 | 0·56 | |
| Childhood outcome | −2·27* (−6·10 to 1·56); 0·247 | 317 | −2·15* (−7·23 to 2·93); 0·408 | 179 | 0·97 | |
| Cervical length at baseline | >15 mm | >15 mm | ≤15 mm | ≤15 mm | ||
| Obstetric outcome | 0·77 (0·48 to 1·23); 0·274 | 599 | 0·91 (0·41 to 2·04); 0·819 | 97 | 0·73 | |
| Neonatal outcome | 0·73 (0·39 to 1·38); 0·334 | 588 | 0·49 (0·18 to 1·31); 0·156 | 94 | 0·50 | |
| Childhood outcome | −2·49* (−5·77 to 0·78); 0·137 | 423 | −0·69* (−8·60 to 7·22); 0·865 | 73 | 0·68 | |
| Chorioamnionitis | No | No | Yes | Yes | ||
| Obstetric outcome | 1·38 (0·55 to 3·45); 0·497 | 115 | 2·17 (0·68 to 6·85); 0·190 | 57 | 0·55 | |
| Neonatal outcome | 0·81 (0·22 to 2·96); 0·752 | 115 | 2·21 (0·76 to 6·40); 0·148 | 56 | 0·24 | |
| Childhood outcome | −2·30* (−10·30 to 5·70); 0·575 | 81 | −1·08* (−11·91 to 9·76); 0·846 | 43 | 0·86 | |
| History of spontaneous preterm birth | No | No | Yes | Yes | ||
| Obstetric outcome | 0·99 (0·51 to 1·92); 0·972 | 273 | 0·82 (0·58 to 1·16); 0·254 | 903 | 0·62 | |
| Neonatal outcome | 1·22 (0·55 to 2·71); 0·620 | 270 | 0·48 (0·29 to 0·79); 0·0042 | 886 | 0·053 | |
| Childhood outcome | −1·11* (−5·96 to 3·73); 0·653 | 201 | −0·14* (−2·79 to 2·52); 0·919 | 656 | 0·73 | |
| History of any preterm birth | No | No | Yes | Yes | ||
| Obstetric outcome | 1·06 (0·53 to 2·12); 0·868 | 250 | 0·81 (0·58 to 1·14); 0·225 | 946 | 0·50 | |
| Neonatal outcome | 1·09 (0·48 to 2·45); 0·836 | 248 | 0·52 (0·32 to 0·84); 0·0079 | 927 | 0·12 | |
| Childhood outcome | −0·91* (−5·92 to 4·11); 0·724 | 187 | −0·37* (−2·96 to 2·23); 0·782 | 681 | 0·85 | |
Logistic or linear mixed effects regression models predicting outcome from treatment, subgroup and the interaction of treatment with the subgroup variable, adjusting for previous pregnancy of at least 14 weeks and a random effect for study centre.
*
Mean difference.