Crowther 1989.
Methods | Randomisation and allocation concealment: the study used block randomisation without stratification to provide balanced numbers in the study groups. Use of consecutively‐numbered, opaque, sealed envelopes. Researchers involved in allocating the women to the treatment groups were not involved in preparing the randomisation schedule. Blinding of outcome assessment: paediatrician examining newborn infants was unaware to which group the mother had been allocated. Documentation of exclusion: no losses to follow‐up. |
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Participants | 139 women with a twin pregnancy and a cervical score of ‐2 or less at or before 34 weeks' gestation attending a special antenatal clinic for multiple pregnancy. Cervical score is length minus dilatation (cm) of the cervix. |
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Interventions | Women allocated to the intervention group received bed rest in the hospital. Women allocated to the control group continued conventional outpatient management and were only admitted to the hospital if pregnancy complications occurred. |
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Outcomes | Primary outcomes
Seconcary outcomes
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Notes | Chorionicity: not reported Sample‐size calculation: reported, 44 women for a 40% (from 80%‐40%) reduction of preterm delivery rate at the 5% level Intention‐to‐treat analyses: performed Compliance: 2 women (3%) in the hospitalisation group did not attend the antenatal ward and 17 women (25%) in the control group were admitted to hospital because of pregnancy complications Location: single centre in Harare, Zimbabwe Timeframe: 1984 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation without stratification to provide balanced numbers in the study groups. Use of a series of consecutively‐numbered, opaque, sealed envelopes. p 851 |
Allocation concealment (selection bias) | Low risk | "The researchers involved in allocating the women to the treatment groups were not involved in preparing the randomisation schedule." p 851 |
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 | "All newborn infants were examined by a paediatrician who was unaware to which group the mother had been allocated." p 851 |
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 information provided about trial protocol or predefined outcomes |
Other bias | Low risk | The study appears to be free of other sources of bias |