Saunders 1985.
| Methods | Randomisation and allocation concealment: random allocation was achieved by reference to a consecutively‐numbered series of sealed envelopes. Blinding of outcome assessment: assessment of duration of gestation at delivery was made by labour‐ward staff who were unaware of the group to which individual women had been assigned. Documentation of exclusion: no loss to follow‐up |
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| Participants | 212 women with a twin pregnancy around 30 weeks' gestation were recruited into the study | |
| Interventions | Women allocated to the intervention group were admitted to the hospital for bed rest from 32 weeks' gestation until the onset of labour Women allocated to the control group were admitted to the hospital only if pregnancy complications occurred |
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| Outcomes |
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| Notes | Chorionicity: not reported Sample‐size calculation: reported, 100 women in each arm would have a 40% chance of detecting a reduction in the risk of preterm birth from 30% to 20% Intention‐to‐treat analyses: performed Compliance: 11 women (10%) in the intervention group declined hospital admission and 2 women delivered before 32 weeks' gestation. In the control group, 58 women (54%) were admitted to the hospital before labour and 1 women delivered before 32 weeks' gestation Location: single centre in Harare, Zimbabwe Timeframe: no information |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random allocation was achieved by reference to a consecutively numbered series of sealed envelopes." p 794 |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and personnel was not possible due to the type of intervention (hospitalisation and bed rest compared with no activity restriction at home) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Assessment of duration of gestation at delivery was made by labour‐ward staff who were unaware of the group to which individual women had been assigned." p 794 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up and analysis on an intention‐to‐treat basis |
| Selective reporting (reporting bias) | Unclear risk | No study protocol available |
| Other bias | Low risk | The study appears to be free of other sources of bias |
NICU: neonatal intensive care unit PPROM: prelabour preterm rupture of the membrane