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. 2013 Jan 31;2013(1):CD007235. doi: 10.1002/14651858.CD007235.pub3

Ness 2007

Methods RCT.
Participants Singleton (and 3 twin) gestations; uterine contractions or symptoms suggestive of PTL 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.
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 TVU CL (< 20 mm): 11/51 (22%) in knowledge group; 7/49 (15%) in the control group.
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 of participants and personnel (performance bias) All outcomes High risk Women and physicians knew which group was randomized to 'knowledge' or 'no knowledge'.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not reported.
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. All other outcomes reported.
Other bias Low risk Baseline characteristics similar.