Summary of findings 3. Intrauterine balloon tamponade plus normal care (misoprostol) compared to normal care (misoprostol) for treating primary postpartum haemorrhage.
| Intrauterine balloon tamponade plus normal care (misoprostol) compared to normal care (misoprostol) for treating primary postpartum haemorrhage | ||||||
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Patient or population: women diagnosed with primary PPH following vaginal birth. Women were suspected to have PPH due to clinical atony and who were quote: "unresponsive to oxytocin and who needed additional uterotonics" p1. PPH was defined as quote: "visual estimation of excessive blood loss and patient status (blood pressure and cardiac frequency)" p 2 (Dumont 2017) Setting: 7 healthcare facilities in Benin and Mail Intervention: intrauterine balloon tamponade (plus misoprostol 'standard care') Comparison: standard care (misoprostol) alone | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with normal care | Risk with intrauterine balloon tamponade (all methods) | |||||
| Mortality due to bleeding | Study population | RR 6.21 (0.77 to 49.98) | 116 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
| 17 per 1000 | 105 per 1000 (13 to 847) | |||||
| Hysterectomy to control bleeding | Study population | RR 4.14 (0.48 to 35.93) | 116 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
| 17 per 1000 | 70 per 1000 (8 to 609) | |||||
| Serious maternal morbidity (renal or respiratory failure, cardiac arrest or multiple organ failure) | Outcome not reported by trial authors | |||||
| Number of women with total blood loss 1000 mL or more after randomisation | Study population | RR 1.52 (1.15 to 2.00) | 113 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 3 | ||
| 525 per 1000 | 799 per 1000 (604 to 1000) | |||||
| Mean blood loss (mL) (trialist defined) | See comment | Outcome not reported by trial authors | ||||
| Blood transfusion (red cell or whole blood) | Study population | RR 1.49 (0.88 to 2.51) | 116 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 4 | ||
| 271 per 1000 | 404 per 1000 (239 to 681) | |||||
| Side effects of the intervention (e.g. trauma, necrosis) ‐ Severe shivering, diarrhoea, vomiting or high temperature | Study population | not estimable | 116 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 5 | ||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). 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. | ||||||
1 We downgraded (‐2) levels for very serious limitations in study design (risk of bias)
2 We downgraded (‐2) levels for very serious imprecision due to small sample size, few events and wide confidence interval crossing the line of no effect
3 We downgraded (‐1) level for serious imprecision due to a small sample size
4 We downgraded (‐2) levels for very serious imprecision due to small sample size, and wide confidence interval crossing the line of no effect
5 We downgraded (‐2) levels for very serious imprecision due to small sample size and zero events