Summary of finding of effects of TxA in women with VWD in the postpartum period
| . | |||||
|---|---|---|---|---|---|
| Outcomes . | Anticipated absolute effects (95% CI)* . | Relative effect (95% CI) . | Participants, n (studies) . | Certainty of the evidence (GRADE) . | |
| Risk with no TxA . | Risk with TxA . | ||||
| Severe primary postpartum hemorrhage assessed according to number of events or deliveries | 313 per 1000 | 112 per 1000 (16-809) | RR 0.36 (0.05 to 2.59) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡,§ |
| Primary postpartum hemorrhage assessed according to number of events/deliveries | 438 per 1000 | 109 per 1000 (18-766) | RR 0.25 (0.04-1.75) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡,§ |
| Secondary postpartum hemorrhage assessed according to number of events/deliveries | 381 per 1000 | 160 per 1000 (76-347) | RR 0.42 (0.20-0.91) | 87 (2 observational studies) | ⨁◯◯◯ VERY LOW†,‡ |
| Blood transfusion assessed according to number of events/deliveries | 188 per 1000 | 45 per 1000 (2-793) | RR 0.24 (0.01-4.23) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,§ |
| Vaginal hematoma assessed according to number of events/deliveries | 125 per 1000 | 43 per 1000 (3-799) | RR 0.34 (0.02-6.39) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,§ |
| Adverse events in mother- Thrombotic complications assessed according to number of events/deliveries | — | — | — | 36 (1 observational study) | ⨁◯◯◯ VERY LOW†,ǁ |
| Blood loss assessed as median per group | The median (range) blood loss after deliveries in people who received TxA was 400 (270-1470) mL, and it was 425 (200-6000) in people who did not receive TxA. | — | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡,¶ | |
| . | |||||
|---|---|---|---|---|---|
| Outcomes . | Anticipated absolute effects (95% CI)* . | Relative effect (95% CI) . | Participants, n (studies) . | Certainty of the evidence (GRADE) . | |
| Risk with no TxA . | Risk with TxA . | ||||
| Severe primary postpartum hemorrhage assessed according to number of events or deliveries | 313 per 1000 | 112 per 1000 (16-809) | RR 0.36 (0.05 to 2.59) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡,§ |
| Primary postpartum hemorrhage assessed according to number of events/deliveries | 438 per 1000 | 109 per 1000 (18-766) | RR 0.25 (0.04-1.75) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡,§ |
| Secondary postpartum hemorrhage assessed according to number of events/deliveries | 381 per 1000 | 160 per 1000 (76-347) | RR 0.42 (0.20-0.91) | 87 (2 observational studies) | ⨁◯◯◯ VERY LOW†,‡ |
| Blood transfusion assessed according to number of events/deliveries | 188 per 1000 | 45 per 1000 (2-793) | RR 0.24 (0.01-4.23) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,§ |
| Vaginal hematoma assessed according to number of events/deliveries | 125 per 1000 | 43 per 1000 (3-799) | RR 0.34 (0.02-6.39) | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,§ |
| Adverse events in mother- Thrombotic complications assessed according to number of events/deliveries | — | — | — | 36 (1 observational study) | ⨁◯◯◯ VERY LOW†,ǁ |
| Blood loss assessed as median per group | The median (range) blood loss after deliveries in people who received TxA was 400 (270-1470) mL, and it was 425 (200-6000) in people who did not receive TxA. | — | 25 (1 observational study) | ⨁◯◯◯ VERY LOW†,‡,¶ | |
In all of the studies, we were very uncertain about the evidence of the effects of postpartum administration of TxA in patients with VWD. The following outcomes: major bleeding, need for other medical procedures, and mortality were not reported in any of the studies.
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.
The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
No adjustment for any potential confounder.
The panel raised applicability concerns regarding the method of outcome measurement.
Very small number of patients and events. The CI suggests appreciable benefit on one extreme and appreciable harm on the other.
No events for this outcome.
Very small number of patients.