Early intrauterine balloon tamponade and severe postpartum hemorrhage risk Image Credit: © Monkey Business - © Monkey Business - stock.adobe.com.
Severe postpartum hemorrhage (PPH) risk is not reduced by early use of intrauterine balloon tamponade(IUBT) compared to use after second-line uterotonic treatment failure and before recourse to invasive procedures, according to a recent study published in the American Journal of Obstetrics and Gynecology.
- The study concludes that initiating IUBT early, alongside second-line uterotonic treatment, does not significantly reduce the risk of severe postpartum hemorrhage compared to using IUBT after second-line uterotonic treatment failure.
- Postpartum hemorrhage is a significant contributor to severe morbidity and mortality in pregnancy-related cases, emphasizing the critical need for improved management strategies.
- When traditional uterotonic treatments fail, various therapies, including uterine compression sutures, pelvic vascular ligation, IUBT, and arterial embolization, are considered. These interventions aim to avoid more invasive procedures like hysterectomy, which require substantial resources.
- In contrast to invasive surgeries, IUBT is a method that can be applied directly in the delivery room, requiring fewer technical and human resources. This underscores its potential as a practical intervention for managing postpartum hemorrhage.
- The study, a multicenter, randomized trial comparing early IUBT with second-line uterotonic treatment to IUBT after treatment failure, involved participants with prolonged postpartum hemorrhage. Despite early IUBT, the analysis did not show a significant impact on the occurrence of severe postpartum hemorrhage.
PPH is a leading source of pregnancy-related severe morbidity and mortality, indicating a need for improved PPH management. Initial PPH treatment includes medical management, uterine massage, and first- or second-lineuterotonic drug use.
Therapies considered when uterotonic treatment fails include uterine compression sutures, pelvic vascular ligation, IUBT, and arterial embolization. Invasive procedures and surgeries such as hysterectomy require significant technical and human resources, highlighting the need for methods such as IUBT which can be applied directly in the delivery room and requires few resources.
It is not clear when the optimal time to use IUBT would be during delivery, but data has indicated early use may be beneficial. To compare IUBT use alongside second-line uterotonic vs IUBT use after second-line uterotonic treatment failure, investigators conducted a multicenter, randomized, controlled, parallel-group, unmasked trial.
Participants included women aged at least 18 years with PPH lasting at least 15 minutes after oxytocin administration and uterine massage following a vaginal delivery between 35 and 42 weeks of gestations. Second-line uterotonic treatment was required in these patients, and they provided written consent.
Exclusion criteria included contraindication to sulprostone, clinical chorioamnionitis, cesarean delivery, hemorrhage cause by cervicovaginal tears without uterine hemorrhage, uterine rapture, medically indicated termination of pregnancy, arterial hemorrhage requiring embolization, placenta accrete, purulent gynecologic infection, cervical cancer, and uterine malformation.
Standardized French guidelines were used to manage deliveries prior to randomization. This included preventive slow intravenous (IV) during the third stage of delivery, bladder catheterization for initial hemorrhage management, and an IV infusion with an electric syringe of sulprostone 500 μg/hour for 1 hour in cases of over 15 minutes of PPH.
In the study group, participants received an IUBT alongside the sulprostone infusion within 15 minutes of randomization. In the control group, the sulprostone infusion alone was initiated within 15 minutes of infusion, with IUBT added if bleeding lasted 30 minutes after the infusion began.
PPH and severe PPH were the primary outcomes of the analysis, with PPH defined by blood loss after delivery of 500 mL or more and severe PPH by blood loss of 1000 mL or more. The need for 3 or more units of packed red blood cells was also used to determine severe PPH.
There were 199 women in the study group and 193 in the control group. Similar characteristics and PPH management were seen in both groups at baseline. At PPH diagnosis, blood loss over 1000 mL was reported in 4.1% of the study group and 0.5% of the control group. At sulprostone infusion initiation, these rates were 33% and 25% respectively.
The median duration between second-line uterotonic and IUBT was 8 minutes in the study group and 33 minutes in the control group. IUBT was given to 193 women in the study group, 15% of which received IUBT more than 15 minutes after the start of second-line uterotonic infusion.
Thirty-nine women in the control group received the IUBT because of continued bleeding despite second-line uterotonic treatment. Of these women, 15 received the IUBT less than 30 minutes after the start of second-line uterotonic treatment.
Severe PPH after treatment was seen in 67.2% of the study group and 74.3% of the control group. This indicates early use of PPH does not significantly impact severe PPH risk.
Rozenberg P, Sentilhes L, Goffinet F, et al. Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial. Am J Obstet Gynecol. 2023;229:542.e1-14. doi:10.1016/j.ajog.2023.05.014