Quenby 1994.
Methods | Country carried out: UK. Date conducted: 1989‐1992. Type of trial design: RCT. Method of randomisation: randomised on formal diagnosis of pregnancy on USS prior to 6 weeks' gestation. Number of centres: 1. Source of funding: none given. |
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Participants | Total number randomised: 81. Total number for analysis: 81. Inclusions:
Exclusions: BMI > 25. |
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Interventions | Treatment arm: IM hCG 10,000 units loading dose, 5000 units twice weekly to week 14. Control arm: placebo (normal saline). Additional interventions: all patients received supportive care. Duration: from USS detection of a pregnancy of under 8 weeks' gestation until 16 weeks. |
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Outcomes | Early pregnancy loss. Late pregnancy loss. |
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Notes | This study compared hCG versus placebo in patients with regular menstrual cycles and those with oligomenorrhoea. In this study the patients with oligomenorrhoea are able to conceive unaided, rather than patients with polycystic ovaries syndrome, rendering it suitable for inclusion in the analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated. |
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 bias apparent in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double bind study. |