Cotton 1984.
Methods | A single‐centre unmasked randomised controlled trial. | |
Participants | 47 women with a diagnosis of PPROM between 26 + 0 and 34 + 0 weeks' gestation at Hermann Hospital (Houston, Texas, USA). 25 (22 available for analysis) women were randomised to the intervention group and 22 (22 available for analysis) women were randomised to the control group. | |
Interventions | Amniocentesis versus no amniocentesis. | |
Outcomes |
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Notes | Days of postnatal hospitalisation could not be included in our review because data were presented as the median and range, which was insufficient to calculate the mean difference between the groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Unclear risk | Not described. |
Allocation concealment | Unclear risk | Not described. |
Blinding (participants and personnel) | High risk | The nature of the intervention prohibited participant and clinician blinding. |
Blinding (outcome assessment) | Unclear risk | Outcome assessor blinding is not described, therefore the risk of bias arising from this is unclear. |
Incomplete outcome data addressed All outcomes | Low risk | Loss of participants to follow‐up and exclusion of participants after randomisation are described adequately. |
Free of selective reporting | High risk | Several outcomes listed in the methods section are not described in the results section. Some outcomes are reported only as showing no difference between the 2 groups, without any quantitative data. |
Free of other bias | Unclear risk | The number of women with multiple gestations is not reported. These women were not excluded from the study, but a subgroup analysis of their effect has not been described. Therefore, the risk of bias arising from the inclusion of women with multiple gestations in the analyses is unclear. |