Methods | RCT. | |
Participants | Singleton (and 3 twin) gestations; uterine contractions or symptoms suggestive of preterm labor at 24 to 33 6/7 weeks. N = 100 | |
Interventions | TVU CL knowledge or not (the control group did receive TVU CL, but results were blinded to managing physicians) Time TVU CL results available: not specified. Protocol for TVU knowledge group: yes. |
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Outcomes | Primary: time from initial evaluation to discharge. | |
Notes | Intention to treat; 97% singletons; protocol for management of TVU CL group, which included management based on FFN for women with CL 20 to 29 mm Short TVUCL ( < 20mm): 11/51 (22%) in knowledge group; 7/49 (15%) in the control group |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer-generated random numbers. |
Allocation concealment (selection bias) | Low risk | Numbered, sealed opaque envelopes. |
Blinding (performance bias and detection bias) All outcomes |
High risk | Women and physicians knew which group was randomized to ‘knowledge’ or ‘no knowledge’ |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Intention-to-treat analyses. |
Selective reporting (reporting bias) | Low risk | Primary outcome time from evaluation to discharge. |