Keywords : Post partum hemorhage · Balloon tamponade · Uterine atony
Uterine atony is a serious condition that can occur any time
after childbirth and can lead to disastrous results if not
addressed and treated at the right time. According to WHO
maternal mortality is unacceptably high, most of the deaths
(94%), occurring in low-resource countries and deaths that
can be easily prevented [1].
With respect to sustainable development goals (SDG) and
maternal mortality, all countries have committed to pursuing
and achieving a new goal of maternal mortality reduction by
2030. SDG3 includes the target of “reducing global maternal
mortality rate to 70 per 100,000 births, with no country
having a maternal mortality rate of more than 2 times the
global average.”
According to the WHO, the majority of women die during or as a result of pregnancy and childbirth. Some complications may exist before pregnancy, but are worsened by pregnancy and childbirth and lack of proper care. Major complications that account for nearly 75% of MMR are [2]
1. Bleeding after childbirth—especially Postpartum Hemorrhage (PPH) 2. Infection after childbirth. 3. Pre-eclampsia, eclampsia and essential hypertension during pregnancy 4. Complications from delivery 5. Unsafe abortions.
Uterine atony is the commonest cause of PPH. According to population-based studies conducted in developed countries, the prevalence of PPH following vaginal birth ranges between 0.8 and 7.9 percent [3–6]. Uterine balloon tamponade is a non-surgical method of treating refractory atonic PPH. The principles of physics behind the balloon tamponade are the same. But the once-considered second-line treatment by the RCOG and ACOG in management in obstetrics is now making and newer and effective comeback in equally treating uterine bleeding disorders in modern operative gynecology. This article reviews the several benefits of this simple, cost-effective and yet therapeutic uses of the balloon tamponade in obstetrics as well as gynecology.
Uterine atony is the commonest cause of PPH. According to population-based studies conducted in developed countries, the prevalence of PPH following vaginal birth ranges between 0.8 and 7.9 percent [3–6]. Uterine balloon tamponade is a non-surgical method of treating refractory atonic PPH. The principles of physics behind the balloon tamponade are the same. But the once-considered second-line treatment by the RCOG and ACOG in management in obstetrics is now making and newer and effective comeback in equally treating uterine bleeding disorders in modern operative gynecology. This article reviews the several benefits of this simple, cost-effective and yet therapeutic uses of the balloon tamponade in obstetrics as well as gynecology.
Principle of Treatment Intrauterine balloon intervention is based on the principle that the device exerts an inward to outward pressure that is greater than the systemic arterial pressure of the patient in order to maintain a “hemostatic effect” and prevent continuous hemorrhaging The “tamponade test” brilliantly elicits the timing of intervention, both medical or surgical in management of obstetric hemorrhage [7].
There are case reports that prove that through ultrasonic intervention, through a transabdominal ultrasound in patients undergoing treatment with balloon tamponade, there might be an alternative mechanism of action. In a first case report documentation of this hypothesis— while the sonographic position is incorrect for conventional uterine balloon catheter use, it suggests an alternate mechanism of action for the balloon: not tamponade of the uterine cavity, but hydrostatic pressure directly around the uterine arteries, a mechanism like mechanical uterine artery embolization or ligation. This concept not only explains how a balloon catheter works, but also challenges conventional wisdom regarding the management of intrauterine bleeding in both obstetrics and gynecology [8].
This principle is now widely used in conditions in modern obstetrics and gynecology, where uterine bleeding is a common complication, e.g., first and second trimester termination of pregnancy [9, 10], cervical pregnancy [11–15], knife cone biopsy [16], laser ablation of the endometrium, dysfunctional uterine bleeding [17], multiple vaginal lacerations [18] and bleeding from cervical stump following postcesarean section sub-hysterectomy [19].
Uses of Uterine Balloon Tamponade in Obstetrics The concept of developing and using condom as a balloon tamponade was simultaneously invented and evaluated as a life-saving technique in low-resource countries like India and Bangladesh, where procuring standard balloon tamponade methods were not affordable given the increased patient load and lesser financial access to standard techniques. This in turn proved to be the basis of several tamponade techniques that have now become the standard norm of practice in controlling uterine bleeding in OBGYN practice. Prof Sayeba Akhter [20] and Prof Shivkar [21] worked simultaneously, unaware of each others work at around the same time, in order to create a successful tamponade for atonic PPH. The failure of initial management in controlling atonic PPH prompts the use of balloon tamponade and “Shivkar’s pack”[21]. Using aseptic precautions, a standard condom is rolled over Foley's catheter #20 and is tied and secured at two places at least 1 centimeter apart. A transvaginal insertion of this Foley's catheter is done using the following techniques.
1. Condom along with the catheter is inserted into the uterine cavity, and the bulb of the Foley’s catheter is inflated to ensure it is placed safely in the uterine cavity. The distal end of the Foley’s is then strapped to either of the thighs to secure its position. The vagina is loosely packed with the roller gauze. And pad dressings are placed outside the vagina. An indwelling bladder catheter is kept in place till the tamponade is secured. The fundal height of the uterus is marked on the abdomen. 2. The distal end of Foley's catheter is connected to a fluid source, preferably a liter of ringer lactate solution. 3. The fluid source is placed at a distance of at least 60 centimeters above the uterus with the patient in horizontal position. The patient is not placed in lithotomy position from here on, i.e., after the successful insertion of the “Shivkar’s pack.” 4. The condom balloon is now inflated. And an airway needle is placed on the bag containing the fluid source to expose the system to external environmental pressure. 5. The equilibrium between this hydrostatic pressure and uterine tone is the basis for "Shivkar's pack."
Fluid is rushed through the tubing after the flow controller is released, inflating and pressurizing the uterovaginal canal. As pressure builds up inside the condom balloon, the fluid flow gradually decreases and eventually stops if there is sufficient uterovaginal tone. If the flow continues indefinitely or eventually increases, we have reached the point of uterovaginal overstretching. This condition will likely result in additional hemorrhage. The fluid source is gradually reduced until the fluid flow is completely stopped or, more preferably, reversal of the fluid flow is observed. This will guard against a uterovaginal condition that is overstretched. After inflating to 300–400 ml of warm saline with a 20-ml syringe, the fluid source is lowered to 25 cm below the abdomen to observe the flow reversal. If no reversal of flow occurs, further lowering by 5 cm every 5 minutes is recommended to observe the reversal of flow. Following observation of the flow reversal, the height of the fluid source is increased if necessary and possible without causing additional appreciable distension (not greater than 50 ml). All uterine tone-increasing measures, such as uterotonics, blood transfusion, oxygen, must be maintained. After packing, blood loss is determined by maintaining a kidney tray at the perineum. When blood loss is less than 25 milliliters per hour, it should be ignored. If it was less than 50 ml, the availability of blood for transfusion is determined. If it exceeds 50 ml, an alternative treatment was sought. However, it is not always necessary [22].Equipment used in shivkar’s pack—provides and excellent alternative for low- to medium-resource countries
Role of Uterine Balloon Tamponade in Gynecological Procedures One of the earliest use of Foley’s balloon tamponade was made by Goldrath et al. [23] expanding the horizon for use of compression balloon tamponade to reduce intrauterine bleeding after hysteroscopic resection of submucous myomas. Since then it has been used with success in several hysteroscopic myoma resections as a means of reducing hemorrhage after gynecological hysteroscopic surgeries. A prospective randomized controlled trial was conducted to determine the efficacy of routine Foley’s catheter tamponade in reducing blood loss following hysteroscopic myoma resection. Dan U et al [24] were clearly able to demonstrate the effectiveness of simple Foley’s balloon tamponade in managing immediate postoperative bleeding following hysteroscopic resection of myomas. The volume of distention of the Foley's was determined in this randomized study based on the preoperative myoma size. For drainage, 5–7ml of saline was injected into the balloon; for tamponade, 10–40ml of normal saline was injected, and the volume determined by the submucous myoma measured on ultrasound prior to the procedure. Surgery was done in the early proliferative phase of the menstrual cycle. Immediately after the surgery Foley’s catheter no 20 was introduced into the uterine cavity and patients were divided into 2 groups—Group A—where Foley’s was introduced for drainage of uterine collection—and Group B—where Foley’s was introduced for tamponade.
This randomized control trial was successful in demonstrating that the use of balloon tamponade was successful in reducing postoperative blood loss after resection of large submucous myomas as compared to the control group. It was however recommended by the study that in order to avoid pressure necrosis of the resected bed, it was wise to sustain the tamponade pressure for maximum upto 6 hours following which the intrauterine Foley’s was deflated to 5–7ml for drainage purpose only.
Modifications of the Intrauterine Balloon Tamponade to Prevent Uterine Hemorrhage Several modifications of the balloon tamponade are in use today to control intrauterine hemorrhage. It is to be noted that Rusch balloon and condom catheter used in Shivkar’s pack, and both do not have extra channel to monitor the uterine drainage and subsequent blood loss. Blood loss in these latter two balloon tamponades is monitored by vaginal packs and pads that are soaked, and hence do not provide the exact estimate of total blood loss, while the former three modifications of the balloon tamponade provide and extra channel where the approximate blood loss could be monitored and further actions could be initiated.
Indications, Contraindiactions and Timing of Use of Balloon Tamponade in Obstetrics and Gynecology The Sheffield guidelines suggest the use of Rusch’s balloon as a prophylactic measure in women who are at a high risk of postpartum hemorrhage and/or when impending postpartum hemorrhage could jeopardize the pre-existing co-morbidities in a pregnant woman [25].
Conflict of interest The authors declare that they have no conflict of interest.
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