Novel intravaginal device for postpartum bleeding passes muster in phase II trial
A less invasive intravaginal device that facilitates bimanual uterine compression appears to work well in the treatment of postpartum haemorrhage, according to the results of a phase II trial.
In the hands of well-trained clinicians, the device was both safe and acceptable, said investigators led by Dr Andrew Weeks from the Liverpool Women's Hospital, Crown Street, Liverpool, UK.
“Most clinicians [who used the device] felt that it provided a useful management tool, both to stop the bleeding and to determine the source of the blood loss, and virtually all would want to use it again,” Weeks added.
Named the PPH Butterfly, the device was designed to be inserted beneath the uterus in place of the fist for a less invasive performance of bimanual uterine compression. This massage technique is performed by inserting one hand in the vagina and pushing against the body of the uterus while the other hand compresses the fundus from above through the abdominal wall. [BMJ Innov 2017;3:45-54]
Although highly effective, bimanual uterine compression can be very painful for the mother (unless an epidural is in place) and tiring for the clinician, Weeks noted. The Butterfly device was developed to achieve the benefits of such a massage technique without being so invasive, thus increasing acceptability of uterine compression among women and clinicians.
Initial safety and efficacy
In the phase II trial, Butterfly was tested in 57 women (mean age 28.8 years, 67 percent primiparous, 47 percent had undergone operative birth) who had postpartum haemorrhage after vaginal birth. All of them received routine intramuscular oxytocin at 10 IU as a prophylactic treatment against postpartum haemorrhage. The cause of the bleeding was atony in 96 percent of the women, with 30 percent also experiencing bleeding from lacerations and 11 percent having retained tissue. [Eur J Obstet Gynecol Reprod Biol 2023;doi:10.1016/j.ejogrb.2023.01.018]
Meanwhile, all participating obstetricians and gynaecologists had received 10 minutes of training on a custom-made mannequin with repeated device insertions to ensure ‘muscle memory’. The device was folded, slid longitudinally into the vagina, and then unfolded and held in place. The uterus was compressed against the device using a hand pressing down the abdomen.
“If the bleeding did not stop with compression, then the device was removed and the genital tract [was] examined for lacerations. If the bleeding stopped, however, then pressure was maintained for 5 minutes. If the bleeding then returned when the pressure was released, the compression was restarted and maintained for a further 5 minutes. This continued for a maximum of five further cycles,” Weeks said.
The median blood loss at the time of device insertion was 750 ml, with Butterfly used for a median of 5 minutes and reinserted a second time in five women when bleeding restarted. Various uterotonics were used along with the device. Specifically, an oxytocin infusion was given in 17 women (30 percent), ergometrine in 15 (26 percent), carboprost in 12 (21 percent), and misoprostol in one (2 percent). A total of 25 women (44 percent) received tranexamic acid.
Only a single woman experienced additional blood loss of more than 1,000 ml, while three women (7 percent) needed a Bakri balloon and eight (14 percent) received a blood transfusion.
In an interview, all but one clinician who used Butterfly agreed that it was easy to use and reported that the device assisted bleeding management in 85 percent of cases. In addition, all 56 study participants who responded to the survey stated that they would want the device to be used again if they bled in a future birth.
No serious adverse events related to the use of the device were documented. However, three events were deemed as ‘possibly’ being caused by the device—two minor vaginal grazes and one postnatal episiotomy infection and breakdown. In three women, lax vaginal tissue complicated the use of the device.
Taken together, the results of the detailed mixed method assessment of the device use provide a holistic view of the Butterfly device from multiple perspectives, Weeks pointed out.
“The use of the device in a normal practice setting also gives insight into how it might function in routine practice. However, both the [participants] and users may not be representative, and a randomized controlled trial is needed to truly assess [the device’s] efficacy,” he added.
“In future, once outside of a study setting, care will be needed to ensure that users are appropriately trained. This is especially important given the potential for entrapped tissue or vaginal wall grazes. Since this study, the PPH Butterfly has been modified to reduce the risk of both, but some risk remains, and monitoring will be needed when introduced into clinical practice,” Weeks said.