Svigos 1982.
Methods | Country carried out: Australia. Date conducted: Type of trial design: RCT. Method of randomisation: randomised on formal diagnosis of pregnancy on USS at 6‐7 weeks. Number of centres: 1. Source of funding: none given. |
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Participants | Total number randomised: 32. Total number for analysis: 16. Inclusions:
Exclusions: none given. |
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Interventions | Treatment arm: IM hCG 9000 units 3 times per week until week 12. Control arm: no treatment. Additional interventions: Duration: from USS confirmation of pregnancy at 6‐7 weeks until week 12. |
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Outcomes | Early pregnancy loss. Pregnancy complications. Labour complications. Congenital defects. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of randomisation was not presented in the paper. However, the author responded that randomisation to either arm of the trial was achieved by generating a random allocation sequence. However, the method of sequence generation is unknown. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients randomised completed the study. |
Selective reporting (reporting bias) | Unclear risk | No reporting bias apparent in the study. |
Other bias | Low risk | No other forms of bias apparent in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method of blinding not stated in the study. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of blinding not stated in the study. |
BMI: body mass index hCG: human chorionic gonadotrophin IM: intramuscular IU: international units RCT: randomised controlled trial USS: ultrasound