Duration of Intrauterine Balloon Tamponade in Post-Partum Haemorrhage Management After Vaginal Delivery: A Secondary Cohort Analysis From the French TUB Trial.

OBJECTIVE

To compare the rates of bleeding recurrence and other post-partum haemorrhage (PPH)-related clinical outcomes in women with PPH initially controlled by intrauterine balloon tamponade (IUBT) according to its duration.

DESIGN

Exploratory cohort study from a randomised trial.

SETTING

Eighteen hospitals in France.

POPULATION: All women included in the randomised trial and managed with IUBT. Those whose balloon was removed within the first 2 h of placement because of spontaneous expulsion and those who underwent invasive procedures before the planned IUBT removal were excluded.

METHODS

The first quartile of the distribution of the IUBT duration was 6.9 h, and we divided the population into two groups according to the duration: ≤ 7 h vs.> 7 h. To control for confounding factors, we used a propensity score adjustment approach.

MAIN OUTCOME MEASURES: Need for an invasive procedure, rate of recurrence of bleeding after removal of the IUBT, and mean quantified peri-partum blood loss.

RESULTS

Totally, 199 women were included. No invasive procedures were performed, and there was no recurrence of bleeding in either group. There were no significant differences in mean (±SD) quantified total blood loss (1126 ± 383 mL vs. 1240 ± 505 mL, p = 0.1) or the need for transfusion (9 [18%] vs. 40 [27%], p = 0.2) between groups, even after adjustment.

CONCLUSIONS

A shorter IUBT duration (7 h) is not associated with unfavourable PPH outcomes and may therefore be a reasonable option if ongoing haemorrhage has abated. However, these findings should be interpreted with caution due to the imbalance in clinical indication between groups.