Janssen 2003.
Methods | Non‐blinded, multicentre, randomized trial | |
Participants | A total of 237 eligible women who had completed 37 to 41 weeks of gestation, and were aged between 15 and 42 years old, participated in this study. 117 participants were randomized to receive home care and 120 to receive telephone triage. 1 person in each group withdrew from the study, but outcomes for both women were retained and analyzed according to intention‐to‐treat. The study took place at the BC Women's Hospital in Canada. | |
Interventions | Experimental group (home visit): the time spent by nurses at participants' homes ranged between 60 and 90 minutes. The nursing assessment at home was identical to a routine admission to hospital and included a brief history, assessment of maternal vital signs etc. The women were instructed in comfort measures such as positioning, relaxation techniques, and standard advice about when to proceed to the hospital. Control group (telephone triage): women in the telephone triage group made their own decision about when to come to hospital, based on their telephone conversation with a nurse from the triage or assessment unit. The decision to come to hospital was made without a clinical assessment. |
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Outcomes |
Primary outcome Epidural analgesia Caesarean delivery Secondary outcomes Labour augmentation Use of electronic fetal monitoring Use of analgesia Cervical dilatation on admission Time from admission to delivery Apgar scores Admission to the neonatal care nursery |
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Notes | Funding source: British Columbia (BC) Health Research Foundation, the BC Medical Services Foundation, the BC Women's Foundation, and BC Women's Hospital Study dates: not reported in trial report Declarations of interest of trial authors: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was accomplished by means of opening consecutively numbered opaque envelopes containing treatment allocation." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was accomplished by means of opening consecutively numbered opaque envelopes containing treatment allocation." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of nurses and physicians caring for participants after hospital admission was not feasible, as women were likely to discuss their early labour experience with their caregivers. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment, and some outcome measurements such as 'use of electronic fetal monitoring' and 'use of analgesia' were likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A total of 237 eligible women participated in this study, 117 of whom were randomized to receive home care and 120 to receive telephone triage. 1 person in each group withdrew from the study, but outcomes for both women were retained and analyzed according to intention‐to‐treat. |
Selective reporting (reporting bias) | Unclear risk | Not enough information provided to enable us to make this judgement. |
Other bias | Low risk | No apparent source of other bias. |