Carlan 1997
Methods | RCT. | |
Participants | Singleton gestations; PPROM; 24 to 34 weeks. N = 92. | |
Interventions | TVU CL or not (the control group did not receive TVU CL). Time TVU CL results available: not specified. Protocol for TVU knowledge group: no. |
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Outcomes | Primary: maternal infection. | |
Notes | Intention‐to‐treat; only singletons; PPROM; no protocol (really a safety study for TVU CL in PPROM women). Short TVU CL (< 25 mm): 14/45 (31%) in knowledge group; not done in other group. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly‐generated assignment." |
Allocation concealment (selection bias) | Low risk | "Randomly‐generated" assignments in sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study group had weekly US while controls had none. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1% explained. |
Selective reporting (reporting bias) | Low risk | Primary outcome was chorioamnionitis. All other outcomes reported. |
Other bias | Unclear risk | No baseline characteristics table. |