Timing of Intrauterine Balloon Tamponade for Postpartum Haemorrhage After Vaginal Delivery Among Women With Moderate Bleeding: Exploratory Analysis of a Randomised Trial

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OBJECTIVE: A randomised controlled trial found no significant reduction in severe postpartum haemorrhage (≥ 3 packed red blood cell units and/or total blood loss > 1000 mL) when intrauterine balloon tamponade and second-line uterotonics were used simultaneously compared with balloon use after failure of second-line uterotonics. However, one quarter of participants had already lost more than 1000 mL at randomisation, increasing heterogeneity and coagulopathy risk. This may have obscured a potential benefit in women with moderate bleeding (500-1000 mL). We aimed to assess the effect of early versus later balloon use in this subgroup. DESIGN: Exploratory analysis of a randomised controlled trial. SETTING: Maternity units across France. POPULATION: Women with 500-1000 mL of blood loss at the time of second-line uterotonic administration after vaginal delivery (n = 264). METHODS: Outcomes were compared between women randomised to early intrauterine balloon tamponade (n = 128) and those who received balloon after failure of second-line uterotonics (n = 136). Risk ratios were estimated using multivariate Poisson regression with robust variance. MAIN OUTCOME MEASURES: Severe postpartum haemorrhage (≥ 3 packed red blood cell units and/or total blood loss > 1000 mL). RESULTS: Severe postpartum haemorrhage occurred in 57.8% of the early group and 70.6% of the later group (adjusted risk ratio 0.83; 95% CI 0.69-1.01; p = 0.06). CONCLUSIONS: Early intrauterine balloon tamponade was not associated with a statistically significant reduction in severe haemorrhage among women with moderate bleeding; estimates are compatible with a modest benefit and should be considered hypothesis-generating.

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