El‐Zibdeh 2005.
Methods | Country carried out: Jordan. Date conducted: 1994‐2000. Type of trial design: RCT. Unit of randomisation: recurrent miscarriage. Method of randomisation: according to day of the week women attended clinic. Timing of randomisation: N/A. Number of centres: 1. Source of funding: N/A. |
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Participants | Total number randomised: 98. Total number for analysis: 98. Inclusions:
Exclusions: > 35 years. |
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Interventions | Treatment arm: IM hCG (Profasi, Serono; Pregnyl, Organon). 5000 IU every 4 days. Control arm: no treatment. Additional interventions: both arms received supportive care; multivitamins, bedrest, standard antenatal follow‐up. Duration: from diagnosis of pregnancy to 12 weeks. |
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Outcomes | Pregnancy loss. Threatened miscarriage. Obstetric complications. Delivery details. Congenital abnormalities. Neonatal death. Adverse effects. |
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Notes | This study assessed the efficacy of hCG versus dydrogesterone compared to a control group. Only the data pertaining to the hCG and control groups have been included here. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Women randomised on day of clinic attendance; quasi‐randomisation. |
Allocation concealment (selection bias) | Unclear risk | Details of allocation concealment not stated in the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All the patients randomised completed the study. |
Selective reporting (reporting bias) | Unclear risk | No selective reporting apparent in the study. |
Other bias | Low risk | No other bias apparent in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Details of blinding methodology not stated in the study. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Details of blinding methodology not stated in the study. |