Janssen 2006.
Methods | Multicentre, randomized trial | |
Participants | This study took place at 7 hospitals in the City of Vancouver, Canada. 2347 eligible women were assessed in this study, 1459 women were randomized (home visit n = 728; telephone support n = 731). No loss to follow‐up in either group. Inclusion criteria of this study were that women lived within a 30‐minute drive of the hospital, were between the ages of 16 and 42 years, had completed 37–41 weeks of gestation, were nulliparous, and were carrying a singleton fetus in the vertex position. | |
Interventions | Experimental (home visit) group: the nursing assessment at home was identical to that over the telephone, but also included maternal vital signs, abdominal palpation, auscultation of the fetal heart rate, assessment of contractions and examination of the cervix. After the assessment, nurses contacted the primary physician by telephone. Control (telephone support/triage) group: study nurses asked women about their contractions (frequency, duration, and strength), and their own assessment of how they were coping over the phone. Both groups of women were given the same advice. |
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Outcomes |
Primary outcome Rate of caesarean delivery Secondary outcomes Rates of admission to hospital in the latent phase of labour (≤ 3 cm cervical dilatation) Number of visits to hospital that did not result in admission Ability to cope with pain on arrival as assessed by the admitting nurse Rates of intrapartum interventions including:
Newborn outcomes:
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Notes | Funding source: Canadian Institute of Health Research Study dates: women were enrolled between 14 August 2001 to 30 October 2004 Declarations of interest of trial authors: not reported in trial report |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation was achieved using a centralised randomisation service. Randomisation was stratified within participating hospitals, with randomly generated block sizes of 6, 8, and 10. |
Allocation concealment (selection bias) | Low risk | The computer‐generated randomisation was achieved using a centralised randomisation service. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Nurses and physicians were not blinded to study allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes were ascertained from study data collected prospectively and from reviews of hospital charts within 24 hours of discharge. Charts were reviewed by trained nursing research assistants. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1459 women participated in this study; 728 women were allocated to the home visit group and 731 women were allocated to the telephone support group. Lost to follow‐up: 0, received allocated intervention: home visit 654 (89.8%), telephone 725 (99.2%). |
Selective reporting (reporting bias) | Unclear risk | Not enough information provided for us to make this judgement. |
Other bias | Low risk | No apparent source of other bias. |