Summary of findings 3. Preterm birth (defined as birth before 37 weeks of gestation).
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: preterm birth (defined as birth before 37 weeks of gestation) 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 versus placebo | 1.08 [0.92, 1.27] | ⊕⊕⊕⊝ MODERATEa |
Unavailable | ‐ | 166 per 1000 (vaginal micronized progesterone) | 152 per 1000 (placebo) |
14 more per 1000 (from 27 fewer to 68 more) |
Dydrogesteroneversus placebo | 0.87 [0.40, 1.88] | ⊕⊕⊝⊝ LOWb |
Unavailable | ‐ | 67 per 1000 (dydrogesterone) | 77 per 1000 (placebo) |
10 fewer per 1000 (from 46 fewer to 68 more) |
17‐α‐hydroxyprogesteroneversus placebo | Unavailable | ‐ | Unavailable | ‐ | 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 | ‐ | 1.25 [0.55, 2.86] | ⊕⊕⊝⊝ LOWc |
See comment* | See comment** | See comment*** |
Recurrent miscarriage | |||||||
Vaginal micronized progesteroneversus placebo | 1.12 [0.67, 1.87] | ⊕⊕⊕⊝ MODERATEa |
Unavailable | ‐ | 103 per 1000 (vaginal micronized progesterone) | 92 per 1000 (placebo) |
11 more per 1000 (from 30 fewer to 80 more) |
Dydrogesteroneversus placebo | Unavailable | ‐ | Unavailable | ‐ | See comment* | See comment** | See comment*** |
17‐α‐hydroxyprogesteroneversus placebo | Unavailable | ‐ | Unavailable | ‐ | See comment* | See comment** | See comment*** |
Oral micronized progesterone versus 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 serious imprecision (wide 95% CIs).
b Direct evidence downgraded ‐1 due to serious limitations in study design and serious imprecision (wide 95% CIs).
c Indirect evidence downgraded ‐1 due to serious limitations in study design and serious imprecision (wide 95% CIs).