|Year : 2015 | Volume
| Issue : 4 | Page : 879-883
Intrauterine balloon catheter in the management of postpartum hemorrhage
Mohamed S Kandeel, Zakaria F Sanad, Mohamed A Emara, Mohamed A Rezk, Ibrahim A Saif-elnasr MSc
Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
|Date of Submission||30-Aug-2014|
|Date of Acceptance||10-Nov-2014|
|Date of Web Publication||12-Jan-2016|
Ibrahim A Saif-elnasr
Shebin El-kom, Menoufia, 32512
Source of Support: None, Conflict of Interest: None
The aim of this study was to evaluate the outcome of uterine balloon tamponade using a condom-catheter in the management of primary postpartum hemorrhage (PPH).
Guidelines for the management of postpartum hemorrhage involve a stepwise approach including the exclusion of retained products and genital tract trauma. Uterine atony, which is the most common cause, is dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced to arrest the bleeding is the uterine tamponade using various balloons and catheters. The condom catheter uses a sterile rubber catheter fitted with a condom that can be used for uterine tamponade.
Materials and methods
This prospective observational study included 50 women with PPH unresponsive to uterotonics and bimanual compression, and was conducted at the Department of Obstetrics and Gynecology, Menoufia University Hospital, Egypt. About 28 patients suffered from atonic postpartum hemorrhage, whereas 22 patients suffered from PPH due to placenta previa. Clinical assessment, laboratory investigations, and intrauterine condom catheter were applied to all patients. The primary outcome was the success of the balloon to stop bleeding; however, maternal complications were assessed as the secondary outcome.
The condom catheter was successful in controlling PPH in all cases of atonic PPH (28/28; 100%): 18 after vaginal delivery and 10 after cesarean section. It successfully controlled PPH due to placental site bleeding in 20 cases (90%) and failed to control PPH in two cases (10%), which were managed by cesarean hysterectomy. There was (P<0.001) a significant statistical difference between vaginal and abdominal balloon insertion regarding postinsertion complications.
The condom catheter controls PPH effectively. It is a simple, inexpensive, and safe method of conserving the reproductive capacity along with saving the life of women with primary PPH.
Keywords: condom catheter, postpartum hemorrhage, uterine tamponade
|How to cite this article:|
Kandeel MS, Sanad ZF, Emara MA, Rezk MA, Saif-elnasr IA. Intrauterine balloon catheter in the management of postpartum hemorrhage. Menoufia Med J 2015;28:879-83
|How to cite this URL:|
Kandeel MS, Sanad ZF, Emara MA, Rezk MA, Saif-elnasr IA. Intrauterine balloon catheter in the management of postpartum hemorrhage. Menoufia Med J [serial online] 2015 [cited 2020 Apr 3];28:879-83. Available from: http://www.mmj.eg.net/text.asp?2015/28/4/879/173607
| Introduction|| |
Primary postpartum hemorrhage (PPH) is defined as an estimated blood loss of more than 500 ml after delivery and occurs with a frequency of around 5%  . An additional definition for PPH after caesarean delivery arbitrarily refers to a blood loss of over 1000 ml  .
First-line treatment options for PPH include conservative management with uterotonic drugs (oxytocin or prostaglandins). Second-line therapy includes uterine packing, external compression with uterine sutures, and selective devascularization by ligation or embolization of the uterine artery ,,,, .
Failure of conservative management is often deemed to warrant hysterectomy, which may be associated with further blood loss and additional morbidity  .
The intrauterine balloon tamponade has been used widely as a second-line procedure in the management of massive PPH before the employment of the more invasive treatments mentioned above  . Various types of balloon catheters have been reported in the literature including the Bakri balloon, the Roush balloon, the Sengstaken-Blakemore tube, and Foleys catheters adapted for intrauterine tamponade  .
The aim of our study was to evaluate the outcome of uterine balloon tamponade using a condom catheter in the management of PPH.
| Materials and methods|| |
This was a prospective observational study conducted on 50 women with PPH unresponsive to uterotonics and bimanual compression. The study participants were recruited from the delivery room in the Department of Obstetrics and Gynecology at Menoufia University Hospital, Menoufia Governorate, Egypt, in the period between May 2011 and September 2012. The local ethical committee at Menoufia University Hospital approved the study protocol, and an informed consent was obtained from all participants before commencing the study.
A total of 50 women with PPH (we defined postpartum hemorrhage as more than 500 ml estimated blood loss after vaginal delivery or more than 1000 ml after cesarean delivery), unresponsive to uterotonics and bimanual compression, were enrolled. About 28 patients suffered from atonic postpartum hemorrhage, whereas 22 patients suffered from PPH due to placenta previa. Patients with traumatic PPH, retained placenta, bleeding tendency, and severe systemic diseases were excluded from the study. During the studied period, out of 2416 deliveries, 168 cases (6.9%) were complicated by PPH. Only cases in which a balloon tamponade was used were abstracted for relevant maternal outcomes.
The standard therapy for PPH includes oxytocin intravenously, followed by intramuscular ergometrine, intramuscular prostaglandin F2-a, and rectal misoprostol as needed. When these measures fail, balloon catheters were used, and if failed, laparotomy with additional operative procedures were performed on the basis of the clinical situation and the attending consultant preference.
The balloon insertion technique
Balloon catheters were inserted in the delivery room or in the operating room under intravenous sedation. We used the condom catheter balloon, which is composed of a latex condom (SURE natural latex condom; Shanghai, China) and a 16-Fr two-way Foley silicon-coated catheter (Egypt). We inflated the catheter balloon, and then punctured it with scissors. After rupture of its balloon, the catheter was inserted inside the condom from its opened distal end till reaching the closed proximal end, and a silk suture was tied around the proximal end of the catheter just below the drainage channel of the catheter and just above the opening of ruptured inflation channel; the silk suture was tied around the distal end of the condom, and the proximal end of the catheter was cut above the proximal tie to create the drainage channel.
The anterior lip of the cervix was secured with ring forceps. The balloon catheter was held with forceps and inserted into the uterine cavity or performed digitally. A tight vaginal pack was inserted to prevent displacement of the catheter.
Insertion at cesarean section
The catheter was inserted through the uterine incision (pushing the tip to the fundus and the drainage port through the cervix into the vagina) or transvaginally and inflated after the uterine incision was closed.
The balloon was inflated with sterile normal saline until the uterine fundus was firmly palpable or no bleeding occurred through the cervix or through the drainage channel or till the base of the catheter was visually inspected through the external os. Usually, we started with an inflation of about 100 ml using a 50-ml syringe with a small tip, followed by reassessment; if the bleeding persisted, inflation was continued with 50 ml till adequate inflation was achieved.
Bleeding was evaluated at the outflow port and at the cervix. The uterine fundus was palpated abdominally and marked with a pen as the reference line from which any uterine enlargement or distention was noted. A tight vaginal pack was then inserted to ensure the maintenance of the correct placement of the balloon and to maximize the tamponade effect.
Oxytocin was infused continuously to keep the uterus contracted (40 IU in 1 l of normal saline).
Triple antibiotics (ampicillin 1 g intravenously every 6 h, gentamycin 80 mg intravenously every 8 h, and metronidazole 500 mg vial intravenously every 6 h) were used to prevent infection for at least 48 h after balloon insertion. Analgesics were used to control the pain. The pulse, the arterial blood pressure, the uterine fundal height, blood in the collection bag of the drainage channel, and the presence of any vaginal bleeding were assessed every 30 min. The temperature was measured every 2 h and the urinary output every hour through an indwelling Foleys catheter. After 24 h, the balloon was removed. After removal of the vaginal pack, the balloon was deflated slowly in about 5-10 min, but remained inside the uterus and was not removed for 30 min. The oxytocin infusion was continued even with no bleeding. When there was still no bleeding after 30 min, the oxytocin infusion was discontinued and the catheter was removed.
We considered failed catheter placement as the inability to insert the catheter inside the uterine cavity or the inability to inflate the balloon after intrauterine insertion of the catheter or displacement of the catheter outside the uterine cavity after intrauterine insertion of the catheter. These cases were excluded from the study ([Figure 1]).
|Figure 1 A flow chart illustrating the total number of deliveries in the study period, the enrolled women, and the excluded cases.|
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We considered failure of the balloon tamponade as the persistence of uterine bleeding 15 min after the balloon catheter was properly inflated, with the need for additional procedures to stop the bleeding.
We considered the procedure successful if the bleeding was stopped by balloon inflation.
The primary outcome measure was the success of the condom-catheter balloon to stop bleeding.
Maternal complications (minor, such as fever and pain, or major, such as blood transfusion, admission to the ICU, hysterectomy, and maternal mortality) were assessed as the secondary outcome.
Data were collected, tabulated, and statistically analyzed by a computer using SPSS version 16 (SPSS Inc., Chicago, Illinois, USA).
Quantitative data are expressed to measure the central tendency of the data and diversion around the mean, mean (X) and SD and P-value.
Qualitative data are expressed in number and percentage.
| Results|| |
During the study period, out of 2416 deliveries, 168 cases (6.9%) were complicated by PPH. There were no maternal deaths. The balloon tamponade was attempted in 57 patients unresponsive to standard first-line measures (uterotonics and bimanual uterine compression), and proper placement was achieved in 50 cases. Bleeding was controlled successfully in 48 (96%) of these 50 cases.
[Table 1] displays the maternal characteristics.
[Table 2] reveals the mode of delivery and the causes of PPH: 28 cases (56%) were due to atonic PPH and 22 cases (44%) secondary to placental site bleeding.
|Table 2 The mode of delivery and causes of primary postpartum hemorrhage among the studied women (n = 50)|
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[Table 3] reveals the outcome of the balloon tamponade. The condom catheter was successful in controlling PPH in all cases of atonic PPH (28/28: 100%): 18 after vaginal delivery and 10 after cesarean section. It successfully controlled PPH due to placental site bleeding in 20 cases (90%) and failed to control PPH in two cases (10%), which were managed by cesarean hysterectomy.
[Table 4] displays maternal complications. Maternal fever affected five cases (1%), abdominal pain requiring additional analgesia in nine cases (18%), blood transfusion in 21 cases (42%), admission to the ICU in eight cases (16%), and hysterectomy in two cases (4%).
[Table 5] reveals (P<0.001) a significant statistical difference between vaginal and abdominal balloon insertion regarding postinsertion complications.
|Table 5 Comparison between both the routes of balloon insertion regarding postinsertion complications among the studied women|
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Placement of the catheter was unsuccessful in two patients in whom the obstetrician was unable to pass the catheter into the uterine cavity due to obstruction by uterine fibroid, failure of balloon inflation occurred in two cases, and catheter displacement after insertion occurred in three cases. All these seven cases were considered as a failure of placement, and not as a failure of the tamponade, and they were excluded from further analysis. They were managed by laparotomy. Stepwise devascularization and B-Lynch sutures were successful in two cases and failed in five cases, which were managed by hysterectomy.
| Discussion|| |
Even with appropriate management, approximately 3% of vaginal deliveries will result in severe PPH. It is the most common maternal morbidity in developing countries and a major cause of death worldwide. The incidence is higher in operative deliveries, especially when conducted under general anesthesia. The incidence is said to be 3.9% in vaginal deliveries and 6.4% in cesarean deliveries  .
We found that the balloon tamponade was highly effective in the management of postpartum hemorrhage unresponsive to standard therapy. Further, the balloon tamponade was highly successful in controlling hemorrhage due to uterine atony (28/28 cases) and in patients with placental site bleeding (20/22 cases), when the catheter was placed properly.
The use of a condom was first described almost simultaneously by authors from India and Bangladesh, who demonstrated the potential life-saving utility of their technique  .
Condous et al.  studied 16 cases of postpartum hemorrhage and used balloon tamponade not only for uterine atony, but also for other conditions. Seror et al.  reported 17 patients with atony or retained products treated with balloon tamponade for postpartum bleeding who failed medical therapy. Bleeding was controlled in 71% of their patients.
A few studies report difficulties or failures in using balloons. Some of these failures may be interpreted as complications of placement. These include obstruction by uterine fibroid, inadvertent damage to the balloon during preparation of the Sengstaken-Blakemore tube while cutting off the tip, inability to place the balloon due to the presence of a B-Lynch suture  , and insufficient insufflations requiring two balloons  .
The small size of our study group and the inability to include a comparison group of patients with similar blood loss who did not have balloon tamponade were the main limitations of our case series.
Future studies should address the optimal duration of balloon and the amount of fluid or balloon pressure required to stop hemorrhage. Because of the ease of use, low cost, availability, low morbidity, and success of these catheters, we recommend the use of condom catheters, which can effectively help in reducing both maternal morbidity and mortality associated with PPH.
| Conclusion|| |
Condom catheters control PPH effectively. It is a simple, inexpensive, and safe method of conserving the reproductive capacity along with saving the life of women with primary PPH.
| Acknowledgements|| |
The authors would like to acknowledge the contribution of the residents and the nursing staff of the labor and delivery ward of Menoufia University Hospital.
Conflicts of interest
There are no conflicts of interests.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]