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Keywords:

  • Intrauterine balloon tamponade;
  • Bakri balloon;
  • postpartum hemorrhage;
  • pregnancy complications

Abstract 

  1. Top of page
  2. Abstract 
  3. Introduction
  4. Material and methods
  5. Results
  6. Discussion
  7. Funding
  8. References

The aim of this study was to evaluate the effectiveness of the Bakri balloon in treating postpartum hemorrhage refractory to medical treatment. This retrospective study included 24 women with postpartum hemorrhage treated with a Bakri balloon as a conservative therapeutic option. The Bakri balloon was successful in controlling hemorrhage in 87.5% of the women. It was effective in all women with vaginal delivery (five of five) and in all women with uterine atony who did not respond to medical uterotonic treatment (eight of eight). Its ease of use and high effectiveness make the Bakri balloon a useful approach for the conservative management of acute postpartum hemorrhage. This device reduces bleeding, shortens the hospital stay and avoids the need for more aggressive procedures.


Abbreviation: 
PPH

postpartum hemorrhage.

Introduction

  1. Top of page
  2. Abstract 
  3. Introduction
  4. Material and methods
  5. Results
  6. Discussion
  7. Funding
  8. References

Postpartum hemorrhage (PPH), an obstetric emergency that can complicate vaginal or cesarean deliveries, accounts for 25% of all maternal deaths worldwide (1). In women who do not respond to uterotonic medical treatment, a variety of procedures, such as arterial embolization, surgical ligation of the uterine arteries or obstetric hysterectomy, may be used.

The Bakri balloon is an intrauterine device indicated to reduce or control PPH temporarily when conservative treatment is warranted. It appears to be an effective alternative for the management of acute PPH refractory to medical treatment, and requires minimal training to use. The device consists of a silicone balloon connected to a catheter of the same material. The collapsed balloon is inserted into the uterine cavity, and when it is inflated with liquid it conforms to the shape of the cavity and stops the bleeding. The blood drains through the central lumen of the catheter, and blood loss can then be evaluated (2). The main advantages described for the Bakri balloon are its easy transvaginal or transabdominal insertion, which can bring about rapid tamponade of the uterine cavity, simplify control of the bleeding and avoid the need for other more invasive procedures, such as hysterectomy.

The aim of this study was to evaluate the effectiveness of the Bakri balloon for the treatment of PPH.

Material and methods

  1. Top of page
  2. Abstract 
  3. Introduction
  4. Material and methods
  5. Results
  6. Discussion
  7. Funding
  8. References

This retrospective study investigated the effectiveness of the Bakri balloon as a conservative treatment option for PPH in women seen at Virgen de las Nieves University Hospital (Granada, Spain) from January 2010 to April 2011. The hospital is a tertiary facility that serves as a reference center for obstetric pathologies. Our study was approved by the center's ethics committee.

Demographic and epidemiological data were recorded, as were factors associated with PPH and variables related to the appropriate use of the Bakri balloon. The study group included women for whom the balloon was inserted vaginally and after cesarean delivery.

Women were considered candidates for treatment with a Bakri balloon if they had PPH that did not respond to standard management consisting of uterine massage, volume replacement and uterotonic medical treatment. The protocol we followed called for uterotonic treatment initially, i.e. intravenous oxytocin or carbetocin, followed by intramuscular methylergometrine if the bleeding was not controlled. If bleeding persisted, intramyometrial prostaglandins (carbopost) were used, and if this did not control the bleeding, misoprostol was given rectally.

Results

  1. Top of page
  2. Abstract 
  3. Introduction
  4. Material and methods
  5. Results
  6. Discussion
  7. Funding
  8. References

A total of 24 cases were identified in which a Bakri balloon was used. Mean maternal age was 36.5 ± 6 years (range 24–48 years). Of the women for whom the balloon was used, 14 (58.3%) were nullipara. Mean gestational age at the time of delivery was 38 weeks (range 34–41 weeks). The main risk factors associated with PPH (3) were cesarean delivery (79.1%), induced labor (29.2%), previous cesarean delivery (29.2%), multiple gestation (29.2%), use of assisted reproduction techniques (25%) and hypertension (20.8%).

Onset of labor was spontaneous in one woman and induced in seven (with oxytocin in all cases), and elective cesarean delivery was used for 16 women. The motive for inducing labor was premature rupture of the membranes in five women, meconium-stained amniotic fluid in one and pre-eclampsia in one. Mean duration of induction before the second stage began was 9 ± 5 h (range 3–15 h).

Of the 24 deliveries, five were vaginal. One was spontaneous and the remaining four required vacuum extraction. In the other 19 women, labor ended in cesarean delivery. The main indications for ending labor with cesarean delivery were contraindication for vaginal delivery (57.9%), maternal pathology (21%), breech presentation (15.8%) and failure of induction (15.8%). Delivery of the placenta was spontaneous in one case, manual in eight and required the Credé maneuver in 15 cases.

The most frequent indication for using the Bakri balloon was bleeding at the placental implantation site, followed by bleeding from the lower uterine segment (Table 1). The mean volume of saline solution used to fill the balloon initially was 257 ± 52 mL (range 150–300 mL), and the time during which the balloon remained inflated was 21 ± 14 h (range 10 min to 48 h). A mean volume of 182 ± 144 mL blood (range 30–575 mL) was drained while the balloon and catheter were in place. While the balloon was in place, uterotonic treatment with oxytocin was given by continuous perfusion.

Table 1. Indications for using the Bakri balloon.
Indication n Percentage
Bleeding from the placental implantation site729.2
Bleeding from the lower uterine segment729.2
Uterine atony833.3
Placenta accreta28.3
Total24100

According to our definition of effectiveness as control of PPH not requiring any further non-pharmacological intervention, the Bakri balloon was effective in 87.5% of the cases (21 of 24 women). Of the three women for whom the balloon failed to control PPH, one was treated with surgical ligation of the uterine arteries and two required peripartum hysterectomy.

There were no complications related with use of the balloon except for pain in one woman, which was treated with an intravenous analgesic. Mean hemoglobin concentration for the whole group after delivery was 8.1 ± 1 g/dL, and 10 women required blood transfusion. Mean length of hospital stay for the whole group was 6 ± 3 days (range 3–17 days).

Discussion

  1. Top of page
  2. Abstract 
  3. Introduction
  4. Material and methods
  5. Results
  6. Discussion
  7. Funding
  8. References

To our knowledge, no randomized studies have appeared on the use of intrauterine balloons; the data available to date are from case series. The importance of the present report lies in the number of women included in our analysis (n= 24) and in the fact that all women in this series were treated with the same device, i.e. an intrauterine Bakri balloon. Other series involving larger numbers of women included cases that were treated with different types of devices.

A study by Vitthala and colleagues (4) included 15 women, and the Bakri balloon was effective in 80% of the cases. For vaginal deliveries, the success rate was 100%, whereas for labors that ended with cesarean delivery, the success rate was only 57%. Georgiou studied 106 cases of PPH (5) that were treated with different types of intrauterine balloons, with an overall success rate of 91.5%.

The design of the balloon is an important consideration. The Bakri balloon is preferable to the Rusch balloon, because blood loss via the drainage catheter can be quantified with the former design. The Bakri device is also preferable to the Foley catheter, because the balloon is more effective in providing intrauterine tamponade. Earlier reports found the Sengstaken–Blakemore balloon to be similar to the Bakri balloon in effectively controlling PPH; success rates with the former device were 81% according to Doumouchtsis and colleagues (6) and 71% according to Seror and colleagues (7). However, the main advantages in comparison to the Sengstaken–Blakemore balloon are that the Bakri device contains no latex, and once inflated, it conforms closely to the interior of the uterine cavity. In one of the largest series involving 23 women (8), the balloon was effective in 90% of the cases. For hemorrhage resulting from uterine atony, the success rate was 100%. This finding is consistent with the results of the present study, in which the balloon controlled PPH in all eight women for whom it was used because of uterine atony.

The effectiveness of intrauterine balloon tamponade is similar to that of other methods used for the conservative management of PPH (9), such as arterial embolization, surgical ligation of the uterine arteries or uterine compression suture. Balloon tamponade can also be used together with the so-called sandwich technique (10). However, intrauterine balloon tamponade is less invasive, faster, and more straightforward to perform; all of these features make this method a useful option as a first step in the conservative management of PPH.

The results of the present study are similar to those published for earlier series of women (4–6). Posptartum hemorrhage was controlled in all five women who delivered vaginally and in all eight with uterine atony who did not respond to medical uterotonic treatment. The effectiveness of the Bakri balloon was not compromised by the presence in some patients of risk factors for PPH, a result that supports the use of this treatment in this type of patient.

The straightforward technique for inserting the Bakri balloon and monitoring blood loss, along with its high effectiveness, make this a useful device for the conservative management of acute PPH that avoids the need for hysterectomy. As a result, the woman's fertility is conserved, blood loss is reduced, and the hospital stay is shortened. Nevertheless, randomized trials are needed to compare the effectiveness of balloon tamponade with other conservative modes of treatment, such as arterial embolization, surgical ligation of the uterine arteries or uterine compression suture. However, prospective randomized studies will be challenging to design and carry out because of the urgent or emergency nature of the context in which treatment decisions need to be made, and the lack of appropriate resources at many centers.

References

  1. Top of page
  2. Abstract 
  3. Introduction
  4. Material and methods
  5. Results
  6. Discussion
  7. Funding
  8. References