Giles 2003
| Methods | Multi‐centred randomised controlled trial ‐ block randomisation, block of 20. Individual women, 2‐trial arm. |
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| Participants | Women with twin pregnancies (monochorionic and dichorionic) at 25 weeks. 2 viable apparently normally formed fetuses seen on ultrasound scan. Exclusions: fetal anomalies; polyhydramnois/oligohydramnois; demise of 1 twin before 25 weeks. Significance of chorionicity not realised at time randomisation began so no attempt was made to assess chorionicity. N = 539 women. |
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| Interventions | Intervention: Doppler and biometry ultrasound.
Comparison: biometry ultrasound.
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| Outcomes | Maternal: antenatal admission, presence of hypertension, gestation at delivery, indication for delivery and mode of delivery. Fetal: ultrasound biometry measurements, umbilical artery doppler systolic diastolic ratios and the occurrence of fetal death and causative factors. Neonatal: birthweight, Apgar scores, admission to NICU, admission to special care nursery, requirements for ventilation and occurrence of neonatal death (up to 28 days of life). |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “....opaque sealed envelopes containing the randomisation code the envelope being opened by an observer remote from patient care”. |
| Allocation concealment (selection bias) | Low risk | “....opaque sealed envelopes containing the randomisation code the envelope being opened by an observer remote from patient care". |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding women and/or staff in these trials was not generally feasible. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding women and/or staff in these trials was not generally feasible. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Describe any loss of participants to follow‐up at each data collection point:
Describe any exclusion of participants after randomisation: was the analysis ITT? If not have the data been able to be re‐included?
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| Selective reporting (reporting bias) | Unclear risk | There seems to be no evidence of selective reporting bias but we have not assessed the trial protocol. |
| Other bias | Low risk | If the study was stopped early, explain the reasons:
Describe any baseline in balance:
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