MacDonald 1972.
Methods | Unit of randomization: pregnancy
Method of randomization: unclear
Timing of randomization: after they were found to have evidence of hormonal imbalance on cervical mucus smears
Power calculation: no
Blinding: yes (double)
Number of centers: 1 specialized antenatal center 40 women randomized, 0 women excluded, 40 women analyzed Source of funding: grant from N.V. Philips‐Duphar |
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Participants | Women with ≥ 2 consecutive proven abortions and then subsequent pregnancy with cervical mucus ferning present | |
Interventions | 2 x 5 mg tablets of dydrogesterone tablets 3 times daily, increased to 4 tablets 3 times daily if ferning persisted, no duration specified Control: placebo |
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Outcomes | Miscarriage | |
Notes | Dates of study: not stated Funding sources: grant from N.V. Philips‐Duphar Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Stated double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not stated but unlikely that knowledge of assignment would influence outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | None |
Other bias | Low risk | None |