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 |
|
| 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 |
|
| Outcomes | Miscarriage | |
| Notes | Dates of study: not stated Funding sources: grant from N.V. Philips‐Duphar Declarations of interest: not stated |
|
| 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 |