Bakri Balloon Placement 

Updated: Jul 05, 2016
Author: Gabor C Mezei, MD, PhD; Chief Editor: Carl V Smith, MD 

Overview

Background

Postpartum hemorrhage (PPH) is a life-threatening complication of delivery. It can occur after vaginal or cesarean delivery and is a major cause of maternal morbidity and mortality in both developing and developed countries as well.[1, 2, 3] The most common cause of PPH is uterine atony; up to 80% of the cases result from suboptimal contraction of the myometrium following placental separation.

After excluding other etiologies of PPH such as retained placenta, uterine rupture, genital tract trauma, uterine inversion, and coagulopathy, the management of uterine atony should be timely and initiated to prevent hemorrhagic, hypovolemic shock, dilutional coagulopathy, tissue hypoxia, and acidosis. The pituitary gland, the kidneys, and the lungs are particularly susceptible organs to damage when perfusion pressure decreases resulting in feared sequelae of postpartum hypovolemic shock such as Sheehan syndrome (ie, postpartum hypopituitarism), renal failure, and acute respiratory distress syndrome.

The repertoires of the management measures can be generally divided into operative and nonoperative interventions. In acute postpartum hemorrhage refractory to medical and other conservative interventions, invasive therapies may include arterial embolization, uterine compression sutures, uterine artery ligation, and, ultimately, hysterectomy. However, these measures are highly invasive, require extensive resources, expertise, and are associated with significant morbidities.

Intrauterine balloon tamponade has been suggested as an effective, easily administered minimally invasive treatment option to control uterine bleeding while preserving the mother’s ability to bear additional children.[4, 5, 6] Multiple types of balloons are available, including Bakri balloon, BT-cath balloon tamponade catheter, Foley catheters, Rusch balloon, condom catheters and the Sengstaken-Blakemore tube. The Bakri postpartum balloon[7] and the BT-cath balloon tamponade catheter[8] are specifically designed for postpartum intrauterine tamponade, and they are the only such devices approved by the US Food and Drug Administration for this application.[9] However, in settings where these are unavailable, other balloons can be used to achieve a similar effect.

In term of mechanism of action, the intrauterine balloon is believed to act by exerting inward to outward pressure against the uterine wall, resulting in a reduction in persistent capillary and venous bleeding from the endometrium and the myometrium.[10]

In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.[1] Global awareness and use of the Bakri postpartum device has grown steadily since 2006 as physicians, hospitals, and other medical institutions have sought effective, minimally invasive means to control uterine bleeding.

Indications

The Bakri balloon is used for temporary control or reduction of postpartum hemorrhage when conservative management of uterine bleeding is warranted, after bleeding from genital tract lacerations and retained product of conception has been excluded. The 2006 ACOG practice bulletin on postpartum hemorrhage by the American College of Obstetricians and Gynecologists states the following:

“When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after vaginal delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. Such approaches can be particularly useful as a temporizing measure, but if a prompt response is not seen, preparations should be made for exploratory laparotomy.”[1]

Although the use of intrauterine balloon catheter is often successful and serves as a definite therapy, it can also be used as a temporary measure to decrease hemorrhage while waiting and preparing for other definite treatment, such as open abdominal surgery (ie, uterine artery ligation, uterine compression suture, hysterectomy) or uterine artery embolization, or while the patient is being transferred to another unit with more experience and resources.

Studies have used intrauterine balloons for bleeding following delivered pregnancies with low-lying placenta and/or placenta previa or invasive or adherent placenta and as an adjunctive treatment of cervical ectopic pregnancy with variable success.[11]

Contraindications

Few contraindications have been highlighted in the use of the Bakri. They include the following:

  • Pregnancy

  • Heavy arterial bleeding requiring surgical exploration or angiographic embolization

  • Cervical cancer

  • Congenital uterine anomaly

  • Uterine distorting pathology (leiomyoma)

  • Suspected uterine rupture

  • Purulent infection of the vagina, cervix, or uterus

  • Allergy to balloon material (silicone)

  • Disseminated intravascular coagulation (DIC)

DIC is listed as a contraindication for balloon tamponade given the complete lack of clinical data. However, theoretically, it can be used to decrease the volume of bleeding and gain time to replenish blood products in preparation for more invasive surgical techniques.

Technical Considerations

Best Practices

The authors recommend that all procedures for management of postpartum hemorrhage be performed on the labor and delivery unit, with an operating room available if an emergency laparotomy becomes necessary.

Procedure Planning

Prior to the procedure, a bedside ultrasound should be used to help assess the uterine cavity to rule out retained product of conception and to assess the angulation and shape of the uterine cavity to help balloon catheter placement.

Complication Prevention

Complications related to intrauterine balloon placements are very rare but potentially include perforation of uterus during placement or inflation and cervical trauma due to inflation at an incorrect location. However, these complications have not been reported in the postpartum uterus. Infection has been reported, but determining whether it is related to the balloon placement is difficult.

To avoid potential risk of air embolism, the balloon should not be insufflated with air or carbon dioxide.

Outcomes

The Bakri balloon is a successful method for postpartum hemorrhage management, and this has been borne out by studies in recent years.[12, 13, 14, 15] Previously, most studies compared the effects of balloon tamponade and other methods to treat PPH, such as uterine compression sutures and arterial embolization, and concluded that no high quality evidence suggests that any one method of management of severe PPH was superior.[16] In a small case series, success rates of uterine balloon catheters for controlling hemorrhage ranged from 57% after cesarean delivery to 100% after vaginal delivery.[4, 16, 17]

The Bakri balloon has clear advantages compared to other intrauterine tamponade devices. These advantages are as follows[9] :

  • Bakri balloon catheter is made of silicone, which is advantageous in patients with latex allergy.

  • The shape more naturally conforms to the uterine cavity compared to other catheters.

  • The risk of uterine perforation may be lower.

  • It comes presterilized and ready to use, whereas the tip of the Sengstaken-Blakemore tube needs to be cut, has extra ports, and is more complicated to use.

To date, no evidence suggests that a Bakri balloon or any other intrauterine tamponade devices would decrease the future reproductive potential and/or would increase adverse pregnancy outcomes in subsequent pregnancies. The literature, however, is limited and further studies are needed.[4, 18]

A study by Kaya et al evaluated the B-Lynch uterine compression suture and Bakri balloon tamponade in severe postpartum hemorrhage and found that the Bakri balloon and the B-Lynch suture had similar success rates in uterine atony during cesarean section. The study added that the Bakri balloon is less invasive and easier to learn, but more time consuming and expensive compared to the B-Lynch suture.[19]

 

Periprocedural Care

Patient Education & Consent

Elements of informed consent

Given that PPH is a true medical emergency, informed consent is not a required part of management. However, if the patient is alert and able to communicate, an attempt of a quick verbal consent should be made.

Pre-Procedure Planning

Prior to the procedure, a bedside ultrasound of the uterine cavity should be conducted to rule out retained product of conception and to assess the angulation and shape of the uterine cavity to guide balloon catheter placement.

Equipment

The Bakri balloon or Bakri Postpartum Device[7] is a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies. Its time-saving catheter is easy to place and monitor and rapidly achieves tamponade within the uterine cavity.

Compared to other similar devices, the Bakri balloon has a relatively large-bore drainage channel that allows for drainage in case of fibrin formation as well. It Includes a 60-mL syringe, intended for one-time use. The manufacturer-recommended volume is 500 mL; the length of catheter shaft is 43.5 cm, and the length of drainage tip is 3.6 cm. It does not contain insufflation valves. The catheter diameter is 24-F (8 mm).[7]

The Bakri balloon remains a successful method for postpartum hemorrhage management. Recent reports have confirmed previous study findings.[12, 13, 14, 15]

Patient Preparation

Anesthesia

Intrauterine balloon tamponade may cause significant pain for the patient and, consequently, adequate analgesia is an important consideration. Although a strong epidural may address the initial hours of pain control in patients who undergo cesarean section or vaginal delivery, providing additional pain relief while the catheter is in place may be necessary later. The pain can be alleviated by reducing the insufflated balloon slightly. However, a balance must be achieved with respect to the tamponade effect and analgesia requirements.

Monitoring & Follow-up

As stated in the device instructional booklet, patient monitoring is an integral part of managing PPH. Signs of a deteriorating or nonimproving condition should lead to a more aggressive treatment and management of patient uterine bleeding.

Rate of Deflation

Manufacturers' package inserts state that the maximum in-dwelling time is 24 hours or less due to concerns about infection and tissue necrosis, but this time interval was not based on any data. The balloon is then deflated, either all at once or gradually over several hours, while monitoring the patient for recurrent bleeding. Emergency surgical services and experienced staff should be readily available when the balloon is deflated in case of recurrent hemorrhage.

If bleeding recurs during deflation or after removal, reinflation or reinsertion of the balloon should not be considered. Persistent or recurrent bleeding is an indication to proceed with other treatment options.

 

Technique

Approach Considerations

After vaginal delivery

For transvaginal placement following vaginal delivery, the following steps should be considered:

  • Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter.

  • Inspection of the uterine cavity should be made to ascertain that the uterine cavity is clear of placental fragments.

  • The cervix and vagina should be cleansed with an antiseptic solution, such as povidone iodine.

  • Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance, making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. This can be also achieved by manual insertion of the catheter similar to insertion of an intrauterine pressure catheter.

  • Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe. The recommended maximum capacity of the balloon is 500 mL.

  • In order to maximize the effect of tamponade most notable to the lower uterine segment, apply gentle traction to the shaft of the balloon. This can be achieved and maintained by securing the balloon shaft to the patient leg or attaching to a weight, not to exceed 500 grams.

  • Connect the drainage port to a fluid collecting bag to monitor hemostasis.

  • Monitor patient continuously for signs of increased bleeding and uterine cramping.

After cesarean section

At laparotomy following a cesarean section, the following specific steps should be considered:

  • Insert the end of the catheter through the open uterine incision to the cervix and then into the vagina.

  • Close the uterine incision while taking special care not to damage the balloon by the suturing needle.

  • Insufflate the balloon under direct visualization.

This may potentially result in balloon failure secondary to incidental puncture of the balloon by the needle. An alternative approach is to close the uterus first and then insert the balloon from the vagina and inflate it while the surgeon watches from above.

The Tamponade Test

The effectiveness of the intrauterine balloon catheter can be assessed by the “tamponade test” first described by Condous and colleagues.[20] This test is considered positive when control is achieved following inflation of the balloon.[21] Patients with a negative test (ie, persistent bleeding despite the balloon placement) should proceed to more invasive therapeutic approaches such as laparotomy or embolization depending on personnel and facilities.

Use of Vaginal Pack

The early publications involving the Bakri balloon suggested the use of a vaginal pack to maintain the balloon in the vagina and to provide additional compression of the lower uterine segment. However, no clear evidence suggests the beneficial effect of this additional approach. If a vaginal pack is to be used, then a positive tamponade test needs to be demonstrated prior to placement of the vaginal pack. Otherwise, a danger exists that the pack will obscure any continuing bleeding leading to a delayed diagnosis of ineffective tamponade.

Use of Antibiotics and Uterotonic Agents

Most experts suggest the use of antibiotics to reduce the risk of iatrogenic infection caused by contamination of the uterine environment by the balloon. However, the effectiveness of antibiotics in this setting has not been studied. Prophylactic (single-dose) administration or for the duration of balloon usage (up to 24 hours) is recommended.

The use of oxytocin or other uterotonics (eg, methylergonovine, prostaglandins) are generally recommended to prevent atony. But again, no clear evidence for this approach exists either

Combination with Other Techniques

External compression plus internal tamponade (uterine sandwich)

Intrauterine balloon catheters can be used in combination with other surgical interventions to potentially increase effectiveness.

One study evaluating the effectiveness of placing an intrauterine Bakri balloon in conjunction with the B-Lynch uterine compression suture in successfully treating uterine atony.[22] Five cases of cesarean deliveries with persistent bleeding from uterine atony refractory to medical treatment and B-Lynch suture underwent Bakri balloon placement with median volume of 100 mL of fluid inflation. The numbers of cases are very small, but the result is promising.

Uterine vessel ligation plus internal tamponade

Hypogastric artery ligation, O’Leary uterine artery ligation, or bilateral looped uterine vessel sutures (B-LUVS) can be also used in conjunction with intrauterine Bakri balloon placement. No scientific data are available at this moment regarding these techniques, but an evaluation of this combinational technique regarding efficacy and safety is ongoing.[9]