Summary of findings 6. Congenital abnormalities.
Patient or population: women with threatened miscarriage or a history of recurrent miscarriage Interventions: multiple progestogens (vaginal micronized progesterone, oral micronized progesterone, dydrogesterone and 17‐α‐hydroxyprogesterone) Comparison: placebo and dydrogesterone Outcome: congenital abnormalities Settings: hospitals | |||||||
Treatment | Direct evidence | Indirect evidence | Anticipated absolute effects for direct estimate | ||||
RR (95% CI) | Certainty | RR (95% CI) | Certainty | Risk with intervention | Risk with comparator | Risk difference with intervention | |
Threatened miscarriage | |||||||
Vaginal micronized progesterone | 1.00 [0.68, 1.46] | ⊕⊕⊕⊝ MODERATEa |
Unavailable | ‐ | 34 per 1000 (vaginal micronized progesterone) | 34 per 1000 (placebo) |
0 fewer per 1000 (from 11 fewer to 16 more) |
Dydrogesterone | 0.71 [0.23, 2.21] | ⊕⊝⊝⊝ VERY LOWb |
Unavailable | ‐ | 24 per 1000 (dydrogesterone) | 34 per 1000 (placebo) |
10 fewer per 1000 (from 27 fewer to 42 more) |
17‐α‐hydroxyprogesterone | Unavailable | ‐ | aUnavailable | ‐ | See comment* | See comment** | See comment*** |
Oral micronized progesterone versus dydrogesterone | Unavailable | ‐ | Unavailable | ‐ | See comment* | See comment** | See comment*** |
Vaginal micronized progesterone versus dydrogesterone | Unavailable | ‐ | 1.41 [0.43, 4.65] | ⊕⊝⊝⊝ VERY LOWc |
See comment* | See comment** | See comment*** |
Recurrent miscarriage | |||||||
Vaginal micronized progesterone | 0.75 [0.31, 1.85] | ⊕⊕⊝⊝ LOWd |
Unavailable | ‐ | 30 per 1000 (vaginal micronized progesterone) | 40 per 1000 (placebo) |
10 fewer per 1000 (from 27 fewer to 34 more) |
Dydrogesterone | Unavailable | ‐ | Unavailable | ‐ | See comment* | See comment** | See comment*** |
17‐α‐hydroxyprogesterone | Unavailable | ‐ | Unavailable | ‐ | See comment* | See comment** | See comment*** |
Oral micronized progesteroneversus dydrogesterone | Unavailable | ‐ | Unavailable | ‐ | See comment* | See comment** | See comment*** |
*No included studies or there are no events in included studies to estimate the baseline risk. **Absolute risk with intervention cannot be estimated in the absence of absolute risk with the comparator. ***Risk difference cannot be estimated in the absence of absolute risks with intervention and the comparator. CI: Confidence interval; RR: Risk ratio. | |||||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.. |
a Direct evidence downgraded ‐1 due to imprecision (wide 95% CIs).
b Direct evidence downgraded ‐1 due to serious limitations in study design and ‐2 due to severe imprecision (wide 95% CIs and number of events less than 30).
c Indirect evidence downgraded ‐1 due to serious limitations in study design and ‐2 due to severe imprecision (wide 95% CIs and number of events less than 30).
d Direct evidence downgraded ‐2 due to severe imprecision (wide 95% CIs and number of events less than 30).