| Methods | Randomized controlled trial. | |
| Participants | 24‐34 6/7 week singletons/twins with 'symptoms of PTL'. Number of participants: 114 (unclear from text) randomized [96 singleton, 12 twins] (analysed: 51/57: knowledge/no knowledge). |
|
| Interventions | FFN knowledge or not. Time FFN results available: 1‐2 hours. Protocol for FFN knowledge group: no. |
|
| Outcomes | Primary: transport rates (not reported). | |
| Notes | 6/114 (?) excluded post‐randomization: not intention to treat; 8 patients entered in study twice!; stopped trial prematurely; sponsored by Adeza; included twins; no protocol. Positive FFN test in each group: 6 (12%) in knowledge, 6 (10.5%) in no knowledge group. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | Computerized opaque envelopes. |
FFN: fetal fibronectin PTL: preterm labor