Response: Manufacturing and Infusion Time for Handmade Intrauterine Hemostatic Balloons: the Shorter, the Better?

We appreciate the observations made by Dr Matsubara regarding our recent study.1 We also emphasize the need for further studies, carried out in the clinical field, in order to verify whether the shorter time for production and infusion with the Alves balloon really has an impact on patient outcomes. We also agree that hemorrhagic control is usually achieved before infusion is completed. Since the infusion time (and total time) was shorter with the Alves balloon, possibly due to the larger caliber and lower resistance of the nasogastric tubes (polyvinyl), we believe that we can also infer that the volume required for tamponade is achieved earlier with this device. If both balloons were tested in the same patient, we believe that the Alves balloon would fill faster with the amount necessary to achieve uterine tamponade, even though this tamponade occurs before the total infusion of the device. The need to consider the mental load of physicians is very interesting as well. We believe that failures in device manufacturing, and/or infusion, are certainly harmful in critical environments. In the present trial, the two outliers that occurred during the manufacture of the El Hennawy balloon were related to the obstruction of the Foley probe at the condom fixation points, making it necessary to undo and redo the two ties, which required excessive time on the part of the participants. We believe that the greater malleability and smaller caliber of the Foley probe requires the caregiver to be more careful in making the condom fixation straps, which can be more difficult in the critical environment. However, we reiterate the shorter time to manufacture the El Hennawy balloon found in our study, an advantage possibly explained by the smaller number of steps required to manufacture this device. We also consider infusion a more automated procedure. However, we believe that continuous skills training can enable caregivers to obtain more automated manufacture of devices. Regarding the infusion of the devices compared here, we can also highlight the need to control the backflow of saline in the infusion intervals of the nasogastric tubes, which can be considered a challenge and, consequently, a disadvantage of the Alves balloon. We also highlight the greater effort required for saline infusion in Foley tubes, also possibly related to their greater malleability and smaller caliber, despite their ability to prevent serum backflow during infusion intervals. We also agree with the third observation. We did not study step two, intrauterine insertion of the balloons to obtain tamponade. We believe that the rigidity of the nasogastric tubes is advantageous, improving the intrauterine insertion of the Alves balloon. In our experience, manual insertion or insertion using tweezers are both easy in terms of progression of the two nasogastric tubes through the cervix and uterine cavity. Until then, we had never experienced or received any reports of injuries in those topographies due to the insertion of this device. We affirm that we are familiar with the technique of “holding the uterine cervix” since its publication in 2016, and we use it with manufactured and industrialized balloons (Bakri, Pergo). However, we apply the following sequence: intrauterine balloon insertion, vaginal insertion of surgical pads (usually two), and infusion. We have observed that the adequate allocation of the pads in the vagina, before starting the infusion, is efficient in preventing vaginal prolapse of the device. Faced with greater difficulties at this stage, we also recommend the “holding the cervix” technique. In conclusion, we would like to emphasize that as most of the participants were professionals in training (fellows in obstetrics), the study provided learning opportunities for manufacturing and infusion of the two devices. Therefore, regardless of the details studied and discussed here, we believe that both devices are effective in preventing maternal deaths from postpartum hemorrhage, and should be valued and disseminated. Finally, we recommend that in places with low availability of industrialized intrauterine balloons, it is necessary that caregivers have the knowledge and skills for the manufacture and proper use of homemade devices.