integrative review: uterine balloon · web viewobjective: the purpose of this integrative review...

Running head: INTEGRATIVE REVIEW: UTERINE BALLOON 1

Integrative Review: Uterine Balloon

Cristina Mardis, RN

Bon Secours Memorial College of Nursing

Nursing Research

NUR 4222

Professor Turner

November 6, 2017

“I pledge”

INTEGRATIVE REVIEW: UTERINE BALLOON 2

Integrative Review: Uterine Balloon

Abstract

Objective: The purpose of this integrative review is to analyze the literature concerning

the effectiveness of intrauterine balloons for post-partum hemorrhages (PPH). Based on the

literature, this integrative review will measure whether the use of uterine balloon, mainly the

Bakri, versus not using one will manage post-partum hemorrhages to prevent further

complications and to avoid more invasive procedures such as a hysterectomy.

Materials and Methods: The method is an integrative review. The search for literature

was conducted using computer-based search engines. There is sufficient information regarding

uterine balloons especially the Bakri balloon. Five articles, within the past five years, were

chosen to conduct this review.

Results: Overall the literature supports the use of uterine balloons, specifically the Bakri

balloon. Four out of the five studies favor the uterine balloons to be used as second line treatment

for controlling PPH. One study stated that the balloon use is beneficial for treating PPH, but not

as advantageous as previously published.

Conclusion: Managing PPHs are critical concerns post-delivery, whether it is for a

vaginal or cesarean delivery. Overall, the studies have suggested that uterine balloons, especially

the Bakri balloon, are beneficial in controlling PPH to prevent more invasive procedures such as

hysterectomy.


Introduction

The purpose of this integrative review is to explore the literature relating to the use of

intrauterine balloons in managing post-partum hemorrhages (PPH) post-delivery via vaginal or

cesarean. Post-partum hemorrhage is the leading cause of maternal complications and even

death. For a vaginal delivery, blood loss greater than 500 mL is considered a hemorrhage. As for

a cesarean delivery, blood loss greater than 1000 ml is considered a hemorrhage. There are

multiple causes are PPH including, but not limited to uterine atony, retained placental products,

trauma to the genital tract, abnormal placentation and clotting disorders (Olsen, Reisner,

Benedetti, & Dunsmoor-Su, 2013). Typically, pharmacologic interventions are the first-line of

defense in a PPH. If uterotonics fail to work alone, surgical interventions such as a hysterectomy

may be considered. Intrauterine tamponade with balloon-like devices has become more apparent

as an effective nonsurgical intervention (Olsen et al., 2013). The statistical information in these

studies illustrates the efficacy of uterine balloons, preferably the Bakri balloon, in controlling

PPH with uterotonic medicines.

Post-partum hemorrhages are considered an obstetrical emergency and are responsible

for a significant percentage of maternal deaths worldwide; therefore, these studies have been

conducted. The researcher expresses interest on this particular topic because they work in

obstetrics and has first-hand experience with PPH at the bedside. The PICO question the

researcher has proposed is as follows: (P) For post-partum hemorrhage patients, (I) does the

insertion and placement of an intrauterine balloon, (C) versus the standard care, (O) decrease the

chances of undergoing more invasive procedures such as a hysterectomy?


Design/Research Method

The research design is an integrative review. The research articles were located using

computer-based search engines such as PUBMED and OVID. The keywords included post-

partum hemorrhage (PPH), Bakri balloon, intrauterine balloon, uterine balloon, tamponade,

vaginal, cesarean, C-section, hysterectomy, and placenta previa. The search generated multiple

articles and five were selected for this review. All five articles are within five years. The years

range from 2012-2016. They are limited to either qualitative or quantitative and written in the

English language. The years range from 2012-2016. The articles were consistent with the PICO

question, “For post-partum hemorrhage patients, does the insertion of an intrauterine balloon,

versus the standard care, decrease the chances of undergoing more invasive procedures such as a

hysterectomy?” The articles were then selected based on the following measures: post-partum

hemorrhage resulting from either a vaginal or cesarean section, intrauterine balloon insertion,

and the effectiveness of the balloon on the hemorrhage. The articles were evaluated to determine

the relevance to the PICO question. After the evaluation, several articles were omitted from the

review. In conclusion, five quantitative articles were selected for this integrative review.

Findings/Results

Overall the literature supports the use of uterine balloons, especially the Bakri balloon.

One study showed that the post-partum hysterectomy rate decreased 55% after Bakri balloons

were introduced. This same study was conducted over an 11 year time-frame at a tertiary hospital

that estimates about 4200 deliveries per year. To be exact, there were 48,767 deliveries within

that period and 30,817 were noted after the introduction of the Bakri balloon. A total of forty

three balloon were placed during the study. They also specified the gestational age to 20 weeks


and/or above. The data collection method was completed using the chi-square testing (Lo, St.

Marie, Yadav, Belisle, & Markenson, 2016).

Another study specifically analyzed the effectiveness of the Bakri balloon for patients

who underwent a cesarean section due to placenta previa. A total of 137 patients were diagnosed

with the previa and their medical records were assessed. The researchers began the study by

evaluating patients who had a PPH and were either treated with a Bakri balloon (balloon group)

or no balloon (non-balloon group). Then, the study became more specific to determine whether

or not the balloon was successful or failure (balloon group). Further analysis was done to

determine factors associated with balloon failure. The balloon success rate was 75% and the

failure group was 25% (Cho, Park, Kim, Jung, & Kwon, 2015). It seems Cho (2015) anticipated

a high likelihood of PPH considering this review was specific to women who were diagnosed

with placenta previa before delivery. Failure of the Bakri balloon was suggestively associated

with the location of the placenta and history of C-sections. The article mentions the average

blood loss in both groups within one hour after the balloon was placed. Five hundred was noted

for the balloon failure group and 60 for the success balloon group. The difference is found to be

significant. There was not much variation between the two groups in terms of maternal age,

gestational age at the time of delivery, the number of pregnancies carried to a viable state, history

of either a vaginal or cesarean delivery, history of a dilatation & evacuation (D&E), or abnormal

findings of the uterus.

A third study stated that the general success rate in avoiding a hysterectomy when the

Bakri balloon was the only intervention was 79%. In most instances, the Bakri tamponade was

the first method of treatment implemented when standard management failed (Kong & To,

2013). Kong (2013) indicated that the most common cause for PPH was uterine atony followed


by placenta previa. A fourth study showed that the Bakri balloon was effective in 87.5%. This

study was conducted in Spain over a 14 month duration and the hospital used for the study serves

as a reference facility for obstetric pathologies (Aibar, Aguilar, Puertas, & Valverde, 2012). The

last study displayed the lowest balloon success rate out of all five reviews, which was 68%. The

68% was compared to previous studies (80-90%) (Olsen et al., 2013). This study was conducted

at a university and a private hospital. The article states that based on maternal demographics,

there was no difference between the success and failure rate.

Two other reviews also showed that balloon failure was associated with patients who had

a cesarean section (Olsen et al., 2013 & Aibar et al., 2012). Multiple commonalities were

identified among the five reviews. There were no complications associated with the use of the

intrauterine balloon. Failure of uterine tamponade were found to be more common in patient’s

device. Uterotonic medications were found to also be a form of treatment for PPH, whether it

was before, during, or after the balloon was placed. The average maternal age differed among the

five studies which suggests that age may be unrelated to the cause of PPH. Three out of the five

studies mention the length of hospital stay in tables. There is no significant difference among the

three reviews. There was no difference in one study, before and after the Bakri balloon, whose

mean length of stay was two days (Lo et al., 2016). There was a one day difference between the

balloon group and non-balloon group, the balloon group ahead by one day (Cho et al., 2015).

The last group shows that the failure balloon group averages one more hospital day (Olsen et al.,

2013).

Discussion

The outcomes of the integrative review address the use of uterine balloons versus

standard treatment in post-partum hemorrhages. Therefore, the findings in this review relate to


and support the researcher’s PICO question. All five quantitative studies showed statistical

significance in clinical outcome measures when the uterine balloon was used. They also mention

a decrease in the rates of hysterectomy. The Bakri balloon is the preferable uterine balloon

according to the five studies. However, one review stated that there were no substantial variances

in success rate when different types of balloon catheters were used for their study (Kong & To,

2013). One study mentions particular reasons why the Bakri device is preferred over other

balloons. For example, the Bakri has more advantages compared to the Sengstaken-Blakemore

balloon such as latex free and once it is inflated, it conforms better to the inferior part of the

uterus (Aibar et al., 2012). Compared to another balloon called the Rusch, blood loss is better

measured. Having a precise amount of blood loss for a post-partum hemorrhage is crucial.

The studies were conducted in various parts of the world which suggests the importance

of intrauterine balloons to be considered as an intervention to manage post-partum hemorrhages.

The sample size for some studies were over twice the amount of patients compared to previous

literature, which is a strength for the review. There were some limitations identified throughout

the literature. Some of the study designs were from single centered facilities. One article stated

that patients who delivered vaginally were not included in the study. Another limitation for the

studies were the retrospective nature of collecting the data. One study specifically mentions that

Bakri balloon use was identified by billing information (Olsen et al., 2013).

Implications/Recommendations

Consistent with the literature, the intrauterine balloon is highly recommended in the

conservative management of a post-partum hemorrhage. The findings from these five reviews

supports the writer’s PICO question. The writer specifically questions the decrease of patients

having to undergo more invasive procedures. Inserting a Bakri balloon is less invasive, quicker,


and uncomplicated to perform. If balloon failure has been determined, other treatment options

need to be rapidly considered to avoid additional maternal injury, complications, and even death.

Proper training of balloon insertion is necessary for practitioners. For facilities that utilize

residents, an attending physician needs to be readily available in the event complications arise

during balloon placement or if there are concerns after the balloon has been placed (Olsen et al.,

2013). Facilities that utilize uterine balloons and anticipate a PPH, need to ensure quick access to

the balloon along with other supplies needed for proper placement.

Limitations

Numerous limitations were recognized by the researcher during this integrative review. It

was challenging and time consuming to search for five articles that were either qualitative or

quantitative that related to one another in order for the researcher to formulate the PICO question

as well as conduct the integrative review. With lack of knowledge and experience with nursing

research, it was challenging for the researcher to understand particular parts of the articles,

especially certain terminology. One challenger was determining if the article’s sample size was

remarkable enough to make it statistically significant. The researcher is going to school part time

and has other commitments, so there is limited time available.

Conclusion

Five current articles that pertained to the researcher’s PICO question were used for this

integrative review. The findings of this review demonstrate the importance of implementing

intrauterine balloons as a conservative management in PPH. The Bakri device was the main

balloon that was used throughout these studies. The literature demonstrates beneficial findings

that include successfully controlling PPH and the decrease in other invasive treatments such as

hysterectomies. Further studies need to be carried out regarding the comparison of the different


types of balloon catheters. There also needs to be further studies that focus on long-term

complications of balloon tamponade. The literature reports that the balloon tamponade is less

invasive, faster, and easier to use. No complications were identified with balloon placement.

Proper training is necessary and needs to be provided to practitioners. Other treatment options

should be readily available if PPH are unresponsive to balloon tamponade.


References

Aibar, L., Aguilar, M. T., Puertas, A., & Valverde, M. (2012, June 12). Bakri balloon for the

management of postpartum hemorrhage. Acta Obstretricia et Gynecologica

Scandinavica, 92, 465-467. https://doi.org/10.1111/j.1600-0412.2012.01497.x

Cho, H. Y., Park, Y. W., Kim, Y. H., Jung, I., & Kwon, J. (2015, August 11). Efficacy of

intrauterine bakri balloon tamponade in cesarean section for placenta previa patients.

PLOS ONE, 1-11. https://doi.org/10.1371/journal.pone.0134282

Kong, M. C., & To, W. W. (2013, December). Balloon tamponade for postpartum haemorrhage:

case series and literature review. Hong Kong Medical Journal, 19, 484-490.

https://doi.org/10.12809/hkmj133873

Lo, A., St. Marie, P., Yadav, P., Belisle, E., & Markenson, G. (2016, July 22). The impact of

bakri balloon tamponade on the rate of postpartum hysterectomy for uterine atony. The

Journal of Maternal-Fetal & Neonatal Medicine, 10, 1163-1166.

https://doi.org/10.1080/14767058.2016.1208742

Olsen, R., Reisner, D. P., Benedetti, T. J., & Dunsmoor-Su, R. F. (2013, May 17). Bakri balloon

effectiveness for postpartum hemorrhage: a “real world experience”. The Journal of

Maternal-Fetal & Neonatal Medicine, 1720-1723.

https://doi.org/10.3109/14767058.2013.796354


First Author (Year)/Qualifications

Laura Aibar, Obstetrics and Gynecology Department at Virgin de las Nieves University Hospital, 2012

Background/Problem Statement

The effectiveness of the Bakri balloon in treating PPH versus medical treatment.

Conceptual/theoretical Framework

Retrospective Study, Quantitative Study

Design/

Method/Philosophical

Underpinnings

It occurred January 2010-April 2011. The study group included women for whom the balloon was inserted vaginally and after cesarean.

Sample/ Setting/Ethical Considerations

24 women with PPH in a tertiary facility. The study was approved by the hospital’s ethics committee.

Major Variables Studied (and their definition), if appropriate

Prior C-section, anterior placenta, thrombocytopenia, presence of DIC (disseminated intravascular coagulation) at the time of insertion, catheter drainage volume greater than 500 ml within one hour of catheter placement.

Measurement Tool/Data Collection Method

Investigated the effectiveness of the Bakri balloon as a conservative treatment option for PPH in 24 women and the demographic and epidemiological data were recorded.

Data Analysis Out of the 24 deliveries, 5 were vaginal. The other


19, labor ended with a cesarean delivery.

Findings/Discussion Intrauterine balloon tamponade is recommended for the first step in conservative management of PPH

Appraisal/Worth to practice

Useful tool in the management of PPH


Hee Young Cho, et al, 2015-Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Institute of Women’s Life Medical Science, Yonsei University College of Medicine, Yonsei University Health System.


Intrauterine balloons are considered non-invasive procedures for PPH. This study is intended to measure the outcomes of Bakri balloon usage for placenta previa during caesarean deliveries and to determine causes as to why it was not successful. Prior studies have reported the benefit of balloon tamponade for substantial PPH regardless of the cause and proposes that balloon tamponade should be part of all protocols in PPH management.


The retrospective study of patients with placenta previa, Quanitative Study

Design/


Underpinnings

Placenta previa was diagnosed in the third trimester via ultrasound. Placenta accreta was diagnosed using a gray scale ultrasound along with several suggestive signs such as the presence of placental vascular lacunae and the loss of a sonolucent area.



137 patients were included in the study who were diagnosed with placenta previa. The study was approved by the institutional review board in Yonsei University Health System. Informed consent was not required due to the nature of the study.


Participants were divided into two groups-one with the balloon tamponade insertion and one without the balloon tamponade. The first group was further divided into the group that only received the balloon tamponade and a group that received pelvic arterial embolization, cesarean hysterectomy, or both of these interventions in addition to the balloon tamponade.


The balloon group was compared to the non-balloon group excluding immediate hysterectomy cases. Medical records were reviewed.

Data Analysis The Mann-Whitney U test was used for categorical variables and two-sample t-test was used for continuous variables.

Findings/Discussion This review on the Bakri balloon catheter is the largest published report to assess a single type of uterine tamponade device for treating PPH caused by placenta previa. This is the first study to statistically explore why the Bakri balloon tamponade. The Bakri balloon placement is considered a failure if within one hour after placement, drainage exceeds over 500 ml.


Bakri balloon tamponade is effective, easy to use, permits rapid placement, and can provide fast results with minimal problems with PPH.


Intrauterine balloon tamponade should be considered as the second-line treatment in massive hemorrhages that do not respond to utertonics.


Meliza CW Kong, MB, ChB, MRCOG, 2013.


In the last few years in Hong Kong, intrauterine balloon tamponade for the management of massive PPH was introduced. A retrospective review was put in place to review a single centre’s experience in treating PPH by balloon tamponade.


Retrospective study of patients who received an intrauterine balloon for massive PPH, Quantitative

Design/


Underpinnings

Case notes of each of the patients were manually reviewed to confirm whether intrauterine balloon tamponade methods had been exploited in their management. The identified cases where the balloon was used or attempted were further reviewed in detail for the type of delivery and intrapartum complications.


The study took place in an Obstetric Unit of a regional hospital in Hong Kong. From January 2011 to June 2012, a retrospective review was conducted of all cases with severe PPH following delivery on the unit. Over the review period, there were 8006 deliveries. 35 patients had a PPH and 19 of them had a Bakri balloon catheter placed. No ethical considerations were mentioned.


35 patients with massive PPH



The comprehensive obstetric database and the Labor Ward registry were reviewed. Case notes of each of the patients were reviewed.

Data Analysis Comprehensive review and comparison of literature with obstetric data base

Findings/Discussion Uterine atony was the most common etiology for PPH, followed by major placenta previa. The overall success rate in stopping a hysterectomy with the Bakri balloon catheter as the only intervention was 79%. The data in this study show that intrauterine balloon tamponade can be used efficiently for the management of massive PPH.


Intrauterine balloon tamponade is recommended for the management of massive PPH.


Anderson Lo, Department of Obstetrics and Gynecology at Baystate Medical Center in Springfield, MA., 2016


Uterine Atony, a major cause of a PPH, has increased over the years. When uterotonics fail to control a hemorrhage because of poor uterine tone, surgical interventions may be required. This may include a hysterectomy. Major complications from a hysterectomy can happen. Therefore, several approaches of intrauterine tamponade have been used to manage a hemorrhage.

Conceptual/theoretical

Retrospective cohort study, quantitative


Framework

Design/


Underpinnings

All women who delivered at 20 weeks gestation or later were identified through the obstetrical electronic medical record.


The study was conducted from January 2002 to March 2013 at Baystate Medical Center, a tertiary hospital. At this facility, there is about 4200 deliveries each year. There are no ethical considerations mentioned.


Patients that had placenta accreta noted after a hysterectomy and patients who had placenta accreta before the Bakri balloon was placed were excluded from the study.

The provider’s clinical judgment and level of comfort determined the Bakri balloon use.


Chi-square testing

Data Analysis Analyzed using R (R Core Team 2015)

Findings/Discussion The postpartum hysterectomy rate has decreased after the use of the Bakri Balloon. 100% success rate in avoiding a hysterectomy after the Bakri balloon insertion. There is significant evidence that balloon tamponade is effective in managing PPH due to poor uterine tone.



The rate of post-partum hysterectomies have reduced due to the usage of the Bakri balloon.


Richelle Olsen, Department of Obstetrics and Gynecology at the University of Washington in Seattle, Wa., 2013


Post-partum hemorrhage is a common and serious complication in obstetrics resulting in morbidities. The use of intrauterine tamponade using balloon like devices has increased and shown to be effective.


Retrospective cohort study, Quantitative

Design/


Underpinnings

At one location, patients were identified by a coding review. At the other location, patients were identified by a chart billing review


The study included 35 women at two different locations-university training program and a large private, nonprofit community hospital. At one site, Formal Institutional Review Board approval was obtained.


Attending physicians, fellows, and residents utilized the balloon at both sites. C-section for mode of delivery, less cervical dilation, Pitocin for induction or augmentation of labor.



Microsoft Excel to STAT/IC 11.1

Data Analysis The collection tool was compared with Student’s t-test and chi-square analysis, Fisher’s exact test, and Wilcoxon’s rank-sum test

Findings/Discussion Success rate at both institutions was 67.57%. Women who delivered by C-section were most likely to have balloon failure. Less post-partum problems when balloon was successful. A strength of this study was the ability to assess over two times the amount of patients compared to previous studies. One limitation was the identification of patients by billing info.


Bakri balloon is beneficial in the treatment of PPH

integrative review: uterine balloon · web viewobjective: the purpose of this integrative review...

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