Pandian 2009.
Methods |
Design: RCT Recruitment method: all women presenting with vaginal bleeding up to 16 weeks of pregnancy were assessed for inclusion Method of randomisation: sealed envelopes picked by the participants Setting: Department of Obstetrics and Gynaecology, Seberang Jaya Hospital |
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Participants |
Inclusion: women with threatened abortion. Viability of fetus confirmed by U/S. no systematic illness or fever and no loss of conception tissue Exclusion: women with recurrent miscarriage (> 3), heavy bleeding, cervical polyp, multiple gestation, empty sac > 26 mm Particpants randomised: 191 women |
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Interventions |
Intervention group: (96 women) 40 mg followed by 10 mg twice daily Control group: (95 women) conservative treatment with bed rest only |
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Outcomes | Miscarriage rate Placenta previa Preterm delivery Congenital anomalies APH Caesarean section Low birth weight Preganancy induced hypertension Perinatal death |
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Notes |
Journal: Maturitas Year of publication: 2009 Country: Malaysia Income status of the country: upper middle‐income Source of funding: Solvay Pharmaceutical Company Conflict of interest: no conflicts |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation of each women using sealed envelope |
Allocation concealment (selection bias) | Low risk | Concealed envelope |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and the study personnel were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only the statistician was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no loss of follow‐up |
Selective reporting (reporting bias) | Low risk | All the prespecified outcomes were addressed |
Other bias | Low risk | No apparent other sources of bias |