Effect of Bakri balloon tamponade combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension undergoing cesarean delivery (2024)

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Medicine (Baltimore)
v.103(11); 2024 Mar 15
PMC10939606

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Medicine (Baltimore). 2024 Mar 15; 103(11): e37533.

Published online 2024 Mar 15. doi:10.1097/MD.0000000000037533

PMCID: PMC10939606

PMID: 38489705

Yeting Liu, MD,^a,^* Yanying Wu, MD,^a Fengjiao Li, MD,^a Xiaocui Song, MD,^a and Jingjing Zhao, MD^a

Author information Article notes Copyright and License information PMC Disclaimer

Abstract

Objective:

To investigate the effect of Bakri balloon tamponade (BBT) combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension (PIH) undergoing cesarean delivery (CD).

Methods:

This randomized, double-blind, controlled trial was conducted at The First Affiliated Hospital of Xingtai Medical College from October 2020 to June 2023. Patients with PIH who had persistent bleeding after CD and were unresponsive to uterine contractions, sutures, or uterine disconnection procedures were eligible participants. Eligible participants were randomly assigned to control and study groups, with 50 patients in each group. The control group used BBT combined with B-lynch uterine compression sutures, while the study group used BBT combined with modified Hayman suture. Intraoperative and postoperative bleeding and changes in vital signs were compared between the 2 groups. Moreover, changes in inflammation levels, coagulation function, and sex hormone levels were compared between the 2 groups before and after surgery.

Results:

Conclusions:

The hemostatic effect of BBT combined with B-lynch uterine compression sutures is comparable to that of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD, but the latter has less blood loss, attenuated inflammatory response, reduced impact on coagulation function and ovarian function, and a lower incidence of adverse events.

Keywords: Bakri balloon tamponade, B-lynch uterine compression sutures, cesarean delivery, modified Hayman suture, pregnancy-induced hypertension

1. Introduction

Postpartum hemorrhage is a common complication of pregnancy-induced hypertension (PIH). Although the development trend of China health industry has improved in recent years, postpartum hemorrhage remains an important cause of maternal safety and death.^[1] Studies have shown that postpartum hemorrhage accounts for approximately 30% of maternal deaths.^[2,3] Moreover, postpartum hemorrhage can cause maternal stress, affect the coagulation system, and activate inflammatory responses in the body, which is not conducive to maternal prognosis.^[1,2] Therefore, postpartum hemorrhage has become a key concern in obstetrics.^[1,3] Postpartum hemorrhage in cesarean delivery (CD) refers to blood loss ≥ 1000 mL within 24 hours. Common hemostatic methods include uterine cavity tamponade, uterine compression sutures (UCS), uterine artery ligation, and blood volume supplementation.^[3] Bakri balloon tamponade (BBT) is a simple and rapid method which achieves hemostasis by inflation and exerting pressure on the internal wound of the uterus to promote clotting.^[4] UCS is currently a widely used hemostatic treatment in obstetrics, which achieves hemostasis by compression of the uterus with sutures, but there is still room for improvement due to the complexity of this procedure, long operation time, and increased risk of infection after maternal exposure.^[5] Our hospital adopts a modified Hayman suture procedure to replace UCS, making the surgical procedure more convenient and effective while ensuring good safety. It can reduce intraoperative blood loss and maternal stress, improve postoperative inflammation levels, and improve maternal prognosis.

2. Materials and methods

2.1. General information

This randomized, double-blind, controlled trial was conducted at The First Affiliated Hospital of Xingtai Medical College from October 2020 to June 2023. Pregnant women with PIH who had persistent bleeding after CD and were unresponsive to uterine contractions, sutures, or uterine disconnection procedures were eligible participants. They were randomly assigned to control and study groups, with 50 patients in each group. The control group used BBT combined with B-lynch UCS, while the study group used BBT combined with modified Hayman suture.

All procedures conducted in research involving human participants complied with the ethical standards of institutions and/or national research committees, as well as the Helsinki Declaration (revised in 2013). The First Affiliated Hospital of Xingtai Medical College Medical Ethics Committee approved this study and written informed consent was obtained from the patients or their legal guardians.

2.2. Eligibility criteria

2.2.1. Inclusion criteria.

Patients diagnosed with PIH according to the “Guidelines for the Diagnosis and Treatment of Pregnancy Induced Hypertension (2020)”;^[6] Patients met the indications for CD surgery and clinical diagnostic criteria for postpartum hemorrhage; Patients with clear consciousness and no cognitive impairment.

2.2.2. Exclusion criteria.

Patients complicated with other major organ lesions; Patients complicated with malignant tumors; Patients with coagulation dysfunction; Patients complicated with diseases of the blood system and immune system; and Patients with poor compliance. Patients with fever above 38°C or chorioamnionitis at CD site; Patients with uterine malformations discovered during surgery; Patients with preoperative uterine artery embolization; After placental delivery, uterine bleeding was controlled after uterine patch and/or local myometrial suture.

2.3. Sample size and randomization

For sample size analysis, it was calculated that each group should have 45 patients, with the efficacy ratio of 95% and the error margin of α of 0.05. This calculation used an effect size of 0.826, which was from studies with similar sample sizes, and the actual efficacy calculation was 0.913. Considering the dropout rate, each group included 50 patients.

A computer-generated randomization code was generated and numbered sequentially. The 2 groups were randomized using a 1:1 ratio with a group size of 4 and were not stratified. Before the study, a statistician from our hospital prepared the numbers and codes and sealed them in an envelope. None of the surgeons knew what these numbers meant. During the persistent postpartum hemorrhage period after CD, if a decision was made to use tamponade, the nurse would open an envelope to confirm allocation.

2.4. Methods

2.4.1. BBT.

After part of the CD incision was sutured, the end of the Bakri balloon was inserted into the lower segment of the uterus through the cervical canal and vagin*, and the other end was pulled out of the vagin*l orifice, and an external drainage bag was attached to count the amount of blood loss. After the balloon was fixed, saline was slowly injected into it, and the amount of water injected should be adjusted according to the bleeding condition of the lower uterine segment. Moreover, be sure to leave10 to 20 mL of space inside the balloon for fixation of the balloon. Until the suturing was completed, the saline in the balloon was replenished as appropriate, and the balloon was removed after 24 hours.^[7]

2.4.2. Control group.

BBT combined with B-lynch UCS: After the patient underwent combined spinal-epidural anesthesia, the patient lower abdominal wall was opened. Then the uterine incision after CD was opened, and the uterus was lifted out. The uterus was exposed by squeezing it and pushing down the bladder peritoneum in the opposite direction. The B-lynch suture method was performed along the lower incisions on both sides of the uterus and 2 to 3 cm medial to the uterus, with a distance of about 3 cm between the left and right needles, and avoiding areas with abundant blood flow in the uterus. The needle was inserted from the anterior wall to the posterior wall, and then the assistant assisted in squeezing the uterus and tying the 2 sutures at the fundus of the uterus. After suturing, the patient uterus was placed back. In the meantime, while squeezing the patient uterus, the amount of vagin*l bleeding was observed for about 15 minutes. Until there was no obvious vagin*l bleeding and the uterine blood flow was normal, the abdomen was closed and sutured.^[8,9]

2.4.3. Study group.

BBT combined with modified Hayman uterine suture: The lower abdominal wall of the patient after combined spinal-epidural anesthesia was opened. Then the uterus was lifted from the original abdominal incision and the lower segment of uterus was exposed by squeezing it and pushing down the bladder peritoneum in reverse. Along the lower end of the left and right sides of the uterus at a distance of 2 to 3 cm, 3 cm medial to the uterus, and 3 cm along the fundus of the uterus near the uterine angle, avoiding areas with abundant blood flow in the uterus, the needle was inserted from the anterior wall to the posterior wall, and a stitch was sutured longitudinally from the seromuscular layer—3 to 4 cm near the uterine angle on both sides of the fundus. During the procedure, the assistant always compressed the uterus with both hands to reduce the risk of blood loss. It is necessary to prevent the pulling sutures from excessively compressing the uterus and causing cutting scars on the surface of the uterus. The knotting technique should be moderate and slow to avoid overly tight or loose stitches. At the same time, while the assistant compresses the uterus, the surgeon wrapped 2 sutures around the anterior wall of the uterus to tie a knot. After suturing, the patient uterus should be returned to its original position in a timely manner. During this period, the patient uterus should be compressed while observing the amount of vagin*l bleeding for approximately 15 minutes until the vagin*l bleeding was no longer obvious, and the uterine blood flow was normal, and then the abdomen was closed and sutured.^[10,11]

2.5. Outcome measures

Blood loss status. The solvent and weighing methods were used for statistical comparison, including intraoperative blood loss, postoperative blood loss at 2 hours, and postoperative blood loss at 24 hours. Blood routine. Venous blood was collected from patients before and 1 day after surgery, and a fully automated blood analyzer was used to detect the decrease in red blood cells and hemoglobin levels in both groups. Coagulation indicators. A fully automated coagulation analyzer (model: CX-9000, manufacturer: Mindray Biomedical Electronics Co., Ltd., Shenzhen, China) and enzyme-linked immunosorbent assay (ELISA) (Wuhan Jilide Biotechnology Co., Ltd., Wuhan, China) were used for analysis, including prothrombin time (PT), ATPP, fibrinogen (Fbg), and d-dimer (D-D). Inflammation level. An ELISA was used to detect the levels of serum C-reactive protein (CRP), interleukin-8 (IL-8), and TNF-α between the 2 groups (kit manufacturer: Shanghai Enzyme Biotechnology Co., Ltd., Shanghai, China). Sex hormone levels. An ELISA was used to detect the levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) in patients before and 1 month after surgery. Postoperative adverse events. Adverse events include dizziness, vomiting, elevated body temperature, chest tightness, and infection.

2.6. Statistic analysis

All data analyses were conducted using SPSS26.0 software (IBM Corp, Armonk, NY, USA). The normality of the data was evaluated using the Shapiro–Wilk test. The data of normal distribution were presented as mean ± standard deviation. Independent sample t test was used for inter-group comparison, and paired t test was used for intra-group comparison before and after treatment. Counting data were presented as the number of cases, and compared using the chi-square test. When P < .05, the differences were considered statistically significant.

3. Results

A total of 122 patients with persistent bleeding after CD were recruited, of whom 22 were excluded (16 cases of uterine contractions and/or local uterine myometrial sutures for hemostasis, 4 cases of preoperative uterine artery embolization, and 2 cases of uterine malformations) (Fig. (Fig.1).1). Finally, 100 patients were included in this study, with 50 in the control group and 50 in the study group. There were no significant differences in age, gestational week, gestational frequency, and BMI between the 2 groups (P > .05) (Table (Table1).1). The hemostasis rate of the study group (96%) was slightly higher than that of the control group (90%), but there was no statistically significant difference between the 2 groups (P > .05) (Table (Table2).2). The intraoperative blood loss, postoperative blood loss at 2 hours, postoperative blood loss at 24 hours, and decrease in red blood cell and hemoglobin in the study group were significantly lower than those in the control group (P < .05) (Table (Table3).3). Before surgery, there was no significant difference in the levels of PT, ATPP, Fbg, and D-D between the 2 groups (P > .05). After surgery, the levels of PT, ATPP, and D-D in both groups were significantly reduced, and the study group was significantly lower than the control group; whereas, Fbg increased, and higher in the study group than in the control group (P < .05) (Table (Table4).4). Before surgery, there were no significant differences in the levels of CRP, IL-8, and TNF-α between the 2 groups (P > .05). After surgery, the levels of CRP, IL-8, and TNF-α in both groups were significantly reduced, and the study group was significantly lower than the control group (P < .05) (Table (Table5).5). Before surgery, there were no significant differences in the levels of FSH, LH, and E2 between the 2 groups (P > .05). After surgery, the levels of FSH, LH, and E2 in both groups were significantly increased, and the study group was significantly higher than the control group (P < .05) (Table (Table6).6). The incidence of postoperative adverse events was significantly lower in the study group than in the control group (P < .05) (Table (Table77).

Table 1

Comparison of general data between the 2 groups.

Group	n	Age (yr)	Gestational age (wk)	Pregnancy time		BMI (kg/m²)
Group	n	Age (yr)	Gestational age (wk)	Primipara	Multipara	BMI (kg/m²)
Control group	50	28.46 ± 2.90	38.64 ± 2.62	36 (72.0)	14 (28.0)	27.15 ± 1.28
Study group	50	28.80 ± 3.10	38.94 ± 2.92	42 (84.0)	8 (16.0)	26.85 ± 1.43
t		−0.567	−0.541	2.089		1.097
P		.572	.590	.148		.275

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Table 2

Comparison of clinical hemostasis rates between the 2 groups.

Group	n	Number of hemostatic cases (n)	Hemostasis rate (%)
Control group	50	45	90.0
Study group	50	48	96.0
χ²			0.154
P			.695

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Table 3

Comparison of blood loss between the 2 groups.

Group	Amount of intraoperative blood loss (mL)	Postoperative blood loss at 2 h (mL)	Postoperative blood loss at 24 h (mL)	Decrease in red blood cell level (×10⁹/L)	Decrease in hemoglobin level (g/L)
Control group (n = 50)	435.34 ± 50.11	219.62 ± 24.49	857.32 ± 100.23	1.18 ± 0.23	34.26 ± 3.30
Study group (n = 50)	328.18 ± 45.46	132.96 ± 18.53	722.06 ± 89.50	0.65 ± 0.16	23.70 ± 4.29
t	11.199	19.951	7.117	13.382	13.801
P	<.001	<.001	<.001	<.001	<.001

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Table 4

Comparison of coagulation function before and after treatment between the 2 groups.

Group	PT (s)		APTT (s)		D-D (mg/L)		Fbg (g/L)
Group	Before	After	Before	After	Before	After	Before	After
Control group (n = 50)	16.35 ± 3.10	13.58 ± 1.63^*	39.33 ± 10.28	26.98 ± 3.41^*	5.94 ± 1.27	2.94 ± 0.59^*	2.50 ± 1.17	6.07 ± 1.11^*
Study group (n = 50)	16.61 ± 3.26	11.20 ± 1.06^*	39.81 ± 11.08	23.25 ± 3.52^*	5.81 ± 1.33	2.64 ± 0.35^*	2.42 ± 1.27	6.60 ± 0.91^*
t	−0.417	8.604	−0.224	5.362	0.488	3.107	0.354	−2.586
P	.678	.000	.823	.000	.627	.002	.724	.011

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Compared with this group before treatment.

^*P < .05.

ATPP = activated partial thromboplastin time, D-D = d-dimer, Fbg = fibrinogen, PT = prothrombin time.

Table 5

Comparison of inflammation levels before and after treatment between the 2 groups.

Group	CRP (μg/L)		IL-8 (μg/L)		TNF-α (μg/L)
Group	Before	After	Before	After	Before	After
Control group (n = 50)	43.09 ± 5.96	34.97 ± 6.15^*	85.67 ± 12.35	66.00 ± 10.20^*	360.21 ± 24.30	165.31 ± 19.55^*
Study group (n = 50)	42.98 ± 5.99	26.85 ± 6.09^*	84.86 ± 11.92	42.23 ± 11.22^*	363.87 ± 25.17	78.23 ± 20.10^*
t	0.095	6.639	0.336	11.082	−0.738	21.963
P	.924	.000	.738	.000	.462	.000

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Compared with this group before treatment.

^*P < .05.

CRP = C-reactive protein, IL-8 = interleukin-8, TNF-α = tumor necrosis factor-α.

Table 6

Comparison of sex hormone levels before and after treatment between the 2 groups.

Group	FSH (U/L)		LH (U/L)		E₂ (pmol/L)
Group	Before	After	Before	After	Before	After
Control group (n = 50)	15.09 ± 3.25	22.23 ± 3.86^*	15.04 ± 3.15	31.28 ± 4.75^*	120.27 ± 14.25	130.14 ± 12.00^*
Study group (n = 50)	15.22 ± 3.21	32.12 ± 4.31^*	15.54 ± 3.31	42.42 ± 5.17^*	121.72 ± 15.01	139.17 ± 13.17^*
t	−0.207	−12.087	−0.771	−11.219	−0.496	−3.742
P	.837	.000	.443	.000	.621	.000

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Compared with this group before treatment.

^*P < .05.

E2 = estradiol, FSH = follicle stimulating hormone, LH = luteinizing hormone.

Table 7

Comparison of postoperative adverse events between the 2 groups.

Group	Dizziness	Vomiting	Increased body temperature	Chest tightness	Infection	Total
Control group (n = 50)	2	4	3	3	6	18 (36%)
Study group (n = 50)	1	3	1	2	2	9 (18%)
χ²						4.110
P						0.043

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Figure 1.

Guidelines flow diagram.

4. Discussion

The study showed that the hemostatic rates of BBT combined with B-lynch UCS are comparable to those of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD. However, BBT combined with modified Hayman suture can effectively reduce postpartum bleeding, attenuate inflammatory response and reduce the impact on coagulation function, and is safe. Excessive postpartum hemorrhage may cause abnormalities in maternal vital signs, which are rapid in onset and progression, and can easily affect multiple organs and systems throughout the body.^[12] If not intervened in, it may lead to hemorrhagic shock and ultimately maternal death.^[1,4]

The pathogenesis of postpartum hemorrhage has not been sufficiently clarified, but studies have shown that there is a close association between postpartum hemorrhage and abnormal coagulation.^[11–13] BBT can mechanically compress the uterine wound and promote coagulation by inflating the sphere with water injection, and it does not interfere with uterine contraction due to the malleability of the Bakri balloon, which is made of soft silicone material.^[4] The design of Bakri balloon fully simulates the morphology of the uterus after CD, and the distal drainage hole can be used to observe the patient vagin*l bleeding during the operation, which is easy to operate and low-cost, and is widely used in clinical practice.^[14,15] UCS is a conventional surgical procedure for treating postpartum hemorrhage, and its earliest application dates back to 1993. The combination of BBT and UCS, also known as “uterine sandwich,” was first introduced in 2007, and subsequently became popularized in clinical practice because of its excellent hemostatic effect.^[8,9,16] However, studies have shown that this method is complex and time-consuming, and may induce uterine myometrial necrosis and increase the risk of infection. Additionally, there is a risk of needle puncture and balloon detachment during the suturing process.^[16,17] The modified Hayman uterine suture is simplified and improved based on B-lynch UCS, which effectively shortens the surgical time. At the same time, this operation adjusts the suture entry above the CD incision to avoid puncturing the Bakri balloon and to reduce cutting damage to the uterine surface.^[10,11] In addition, the study showed that the intraoperative blood loss, postoperative blood loss at 2 hours, and postoperative blood loss at 24 hours, and decrease in red blood cell count and hemoglobin in the study group were lower than those in the control group, indicating that the control of blood loss in the study group was better than that in the control group. We suspect it may be because this surgery can effectively compress the arcuate blood vessels of the uterine wall, promote uterine contraction, and achieve rapid hemostasis. Simultaneously, the simpler operation shortens the surgical time and further reduces the amount of blood loss. For postpartum hemorrhage, accelerating the recovery of coagulation function can enable the body blood to coagulate rapidly and the hemostatic function to work quickly.^[18] Elevated PT and activated partial thromboplastin time (APTT) indicate abnormal coagulation, while decreased PT and APTT indicate that the body is in a hypercoagulable state, which can reduce the risk of bleeding. Fbg reflects plasma viscosity, and an increased level indicates that the blood in the body is in a hypercoagulable and fibrinolytic state.^[19] This study showed that the PT, APTT, and D-D levels in the study group decreased, while the Fbg levels increased significantly compared to the control group. Patients in the study group had high levels of coagulation-promoting factors in their blood, with a decrease in Fbg and anticoagulant levels, resulting in a consistently high blood coagulation state, which can accelerate wound healing. This study also found that 1 month after surgery, the levels of FSH, LH, and E2 in the study group were significantly higher than those in the control group. It may be that the 2 different surgical methods can affect the blood supply to the ovaries, leading to differences in fluctuations in sex hormone levels, which suggests that the modified Hayman uterine suture may be able to minimize the damage to the ovaries and fluctuations in sex hormone levels. Research has shown that postpartum hemorrhage may lead to stress in patients, thereby activating their inflammatory state.^[20] CRP, IL-8, and TNF-α are commonly used inflammatory markers in clinical practice, which can reflect inflammation and tissue damage.^[21] The current study showed that the CRP, IL-8, and TNF-α levels in the study group were lower than those in the control group, indicating that the treatment methods of the study group can reduce patient stress, alleviate the inflammatory state in patients, and reduce suture damage to the body. Moreover, the increase in CRP, IL-8, and TNF-α may also indicate the risk of infection, and the study group have a lower risk of infection. Safety analysis showed that the incidence of adverse events in the study group was lower than that in the control group, indicating that the modified Hayman uterine suture procedure has a safer profile.^[22]

Limitations of this study: First, only 100 samples were included and no further relevant indicators were observed, making the conclusions somewhat subjective and one-sided. Second, the study was a single-center trial, so the results may not be extrapolated to other regions. Third, the inclusion criteria for “persistent bleeding” were based on personal judgment and were therefore not standardized. Last, the follow-up period was relatively short in this study, and long-term complications were not investigated.

5. Conclusion

The hemostatic effect of BBT combined with B-lynch UCS is comparable to that of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD. However, the latter has less blood loss, attenuated inflammatory response, reduced impact on coagulation function and ovarian function, and a lower incidence of adverse events. Thus, it is worthy of further clinical promotion and application.

Author contributions

Conceptualization: Yeting Liu.

Data curation: Yanying Wu and Fengjiao Li.

Formal analysis: Xiaocui Song.

Investigation: Jingjing Zhao.

Writing – review & editing: Yeting Liu.

Abbreviations:

APTT: activated partial thromboplastin time
BBT: Bakri balloon tamponade
CD: cesarean delivery
CRP: C-reactive protein
D-D: d-dimer
E2: estradiol
ELISA: enzyme-linked immunosorbent assay
Fbg: fibrinogen
FSH: follicle stimulating hormone
IL-8: interleukin-8
LH: luteinizing hormone
PIH: pregnancy-induced hypertension
PT: prothrombin time
TNF-α: tumor necrosis factor-α
UCS: uterine compression sutures

The authors have no funding and conflicts of interest to disclose.

Our study was approved by the Ethics Review Board of The First Affiliated Hospital of Xingtai Medical College.

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

How to cite this article: Liu Y, Wu Y, Li F, Song X, Zhao J. Effect of Bakri balloon tamponade combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension undergoing cesarean delivery. Medicine 2024;103:11(e37533).

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