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. 2013 Jan 31;2013(1):CD008611. doi: 10.1002/14651858.CD008611.pub2

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.
Participants Total number randomised: 32.
Total number for analysis: 16.
Inclusions:
  • 2 or more consecutive miscarriages.


Exclusions: none given.
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.
Outcomes Early pregnancy loss.
Pregnancy complications.
Labour complications.
Congenital defects.
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