A method to improve the effectiveness of the Bakri balloon for management of postpartum hemorrhage at cesarean

The Bakri balloon, which is used as a uterine tamponade, is the only balloon product specifically designed for the control of atonic postpartum hemorrhage (PPH); however, it may lose its effect if displaced into the vagina [1–4]. The aim of the present study was to evaluate the effectiveness of a new technique for keeping the balloon inside the uterine cavity. Between April 1, 2004, and April 30, 2009, a study was conducted among women with severe atonic PPH during emergency cesarean, following failed attempts at medical treatment, at the Security Forces Hospital, Riyadh, Saudi Arabia. The hospital Ethics Committee approved the study, and informed consent was obtained from all participants. Women who were less than 28 weeks pregnant, and those with traumatic bleeding or placenta previa were excluded. All participants had undergone cesarean for different indications at 6 cm to full dilation of the cervix, and in all cases coagulopathy had been excluded as the cause of or a catalyst for hemorrhage. Following failed attempts at medical treatment for PPH, a Bakri balloon (Cook, Bloomington, IN, USA) was placed inside the uterine cavity during cesarean. Women who required the balloon tamponade were randomized (via computer-based random assignment) into 2 groups: the traction stitch group (n = 25; study group); and the non-traction stitch group (n = 25; control group). In the study group, the Bakri balloon was fixed with nylon loop stitching through the hole of its proximal shaft, and the needle was then passed through the uterine cavity and the anterior abdominal wall (Fig. 1). The thread was fixed to the skin to keep the balloon within the uterine cavity without any additional packing or the insertion of a balloon vaginally (Fig. 1). This is a new technique perfected by the authors, and no reports have described it previously. In the control group, the balloon was left inside the uterine cavity without any traction stitching, additional packing, or the insertion of a balloon vaginally. In both groups, the distal end of the balloon was passed through the cervical opening, with an assistant pulling that end vaginally. Bakri balloon fixed with a stitch to the skin of the anterior abdominal wall. The Bakri balloon can be fixed with nylon loop stitching through the hole of its proximal shaft (A). The needle is then passed through the uterine cavity (B) and the anterior abdominal wall (C). The thread is fixed to the skin (D) to keep the balloon within the uterine cavity. The uterine incision was sutured before refilling the balloon with saline solution. The balloon was inflated until it conformed to the contour of the uterus in order to provide a symmetric tamponade effect. All patients were administered intravenous broad-spectrum antibiotics for the first 48 hours and underwent oxytocin infusion for 8 hours. The balloon was removed after 24 hours in the presence of a consultant to determine whether bleeding had stopped. The procedure was considered successful if the bleeding was minimized, or unsuccessful if another surgical procedure (e.g. uterine or internal iliac artery ligation, uterine artery embolization, and/or hysterectomy) was needed to stop the bleeding. Only a small number of patients consented to involvement in the study and, because there was a high rate of balloon displacement in the control group, the comparison was stopped after 50 cases. Statistical analyses were performed using the Mann–Whitney test. P < 0.05 was considered to be statistically significant. In the study group, the balloon remained in situ without migration to the vagina in all cases, via the effect of the traction stitching. Removal of Bakri balloon plus traction stitching is easy, painless, and unlikely to cause trauma or complication; the balloon is deflated and, if no bleeding occurs, the traction stitch can be cut and the balloon withdrawn vaginally. After Bakri balloon deflation in the present study, only 1 (4.0%) woman in the study group experienced bleeding and, because the balloon was still in situ owing to the stitching, reinflation was carried out, after which the patient underwent bilateral uterine artery embolization. The balloon was deflated again 4 hours after embolization, at which time the bleeding had been controlled. In 10 (40%) women in the control group, the balloon migrated to the vagina, with continuation of bleeding in 8 of these 10 cases. Replacement of the balloon controlled the bleeding for 3 women, whereas 3 required uterine artery and internal iliac artery ligation, and 2 required hysterectomy to control the bleeding. Thus, the success rate was 96% in the study group, compared with 80% in the control group, and 88% overall (Table 1). This compares favorably to a success rate of 80% reported for Bakri balloon insertion without traction stitching [2–4]. No bleeding or other complications were present at the site of traction stitching. In all cases in both groups, the balloon was removed 24 hours after insertion. The optimal timing interval for the tamponade to remain in situ needs to be assessed in future studies. Displacement of the Bakri balloon, through a dilated cervix, from the uterine cavity to the vagina can decrease its effect in controlling atonic PPH. To improve the effectiveness of the procedure, the use of a vaginal pack in the form of ribbon gauze plus a Sengstaken–Blakemore tube or, alternatively, an inflated condom in the vagina to hold the balloon in the uterine cavity has been recommended [1,2]. Over-inflating the balloon while it is in the uterus is also an option to prevent migration of the balloon into the vagina, but over-inflation may cause other problems [1,2]. Therefore, one should aim for the minimal amount of uterine distention to accomplish homeostasis. The amount of saline fluid instilled to inflate the balloon in the present study ranged from 300 to 500 mL, depending on the size and capacity of the uterus. Others have reported the use of intrauterine balloons without vaginal packing or vaginal balloon [1–3]. There is often a risk of displacement, even if the above-mentioned methods are used. We recommend the use of a traction stitch to keep the Bakri balloon within the uterus. This increases the success rate of the balloon in controlling atonic PPH compared with its use without a stitch. When reinflation of the balloon is necessary in cases of bleeding after deflation, the traction stitch may prevent the balloon from being displaced completely into the vagina and may assist in further management of intractable PPH. The authors have no conflicts of interest.