Abstract
This retrospective study aimed to investigate the preventive effects of Shenghua decoction (SHD) for postpartum hemorrhage (PPH) attributed to uterine atony (UA). Records of 84 patients were retrospectively analyzed, with 42 assigned to the treatment group and 42 to the control group. Both groups received carbetocin, and patients in the treatment group additionally underwent SHD. Primary endpoints included blood loss and changes in hemoglobin levels. Secondary endpoints encompassed the number of patients requiring uterine massage, additional oxytocic drugs, pulse rate, respiratory rate, systolic blood pressure, and treatment-related adverse events. Patients in the treatment group exhibited superior outcomes in terms of blood loss (P < .01), hemoglobin levels (P = .03), and pulse rate (P < .01) compared to those in the control group. However, no significant differences were observed in the number of patients requiring uterine massage (P = .13), the number of patients needing additional oxytocic drugs (P = .19), respiratory rate (P = .05), and systolic blood pressure (P = .80) between the 2 groups. There were no significant disparities in treatment-related adverse events between the 2 groups. The findings of this study suggest that the preventive effects of SHD combined with carbetocin were superior to those of carbetocin alone for preventing postpartum hemorrhage. However, high-quality prospective studies are needed to validate and confirm these results.
Keywords: carbetocin, postpartum hemorrhage, Shenghua decoction, uterine atony
1. Introduction
Postpartum hemorrhage (PPH) is characterized by excessive bleeding following childbirth, medically defined as the loss of more than 500 mL of blood within 24 hours of delivery.[1–4] It represents a significant concern in maternal health as the leading cause of maternal mortality worldwide.[4–8] The World Health Organization attributes approximately 25% of the 500,000 maternal deaths annually to PPH.[9] Despite advancements in preventive measures and management strategies, PPH affects 3% to 10% of all deliveries,[9–11] emphasizing the ongoing need for research and improved protocols. Understanding contributing factors and implementing effective interventions is critical for reducing the incidence and impact of this condition.
Various risk factors are implicated in the development of PPH. These factors include uterine atony (UA), characterized by inadequate contraction of the uterus postdelivery; trauma, which encompasses injuries sustained during childbirth; retained placenta, where parts of the placenta remain in the uterus following delivery; and coagulopathy, a disorder affecting blood clotting mechanisms.[12–16] Identifying and addressing these risk factors are crucial in the prevention and management of PPH in obstetric practice. Among the various risk factors contributing to PPH, UA accounts for over 80% of cases.[17] Typically, after placental delivery, the uterine muscles contract to constrict blood vessels and prevent excessive bleeding.[18] In UA, however, this contraction does not occur, leading to PPH.[18] Following placental delivery, the uterine muscles undergo a coordinated contraction process aimed at constricting blood vessels within the uterine wall. This physiological response is pivotal in averting excessive postpartum bleeding by effectively sealing off vascular channels.[18] UA disrupts the normal course of postpartum uterine contraction. This failure of the uterine muscles to adequately contract leads to an inability to constrict blood vessels effectively, resulting in continued bleeding beyond normal limits.[18] Given the substantial role of uterine muscle contraction in preventing PPH, the administration of prophylactic drugs becomes imperative in clinical practice. These drugs are designed to promote uterine muscle contraction and vascular constriction, thereby reducing the risk of excessive postpartum bleeding.[18]
Carbetocin, a pharmaceutical agent targeting oxytocin receptors in peripheral organs, has shown promise in the management of PPH according to a range of studies.[18–22] While multiple research endeavors have highlighted the potential of carbetocin in PPH control, its effectiveness has not consistently met the desired benchmarks.[18–22] Emerging evidence suggests that Shenghua decoction (SHD), a traditional Chinese herbal formula, may have additional benefits in controlling PPH.[23–25]
SHD is a traditional Chinese herbal formula used for postpartum care.[23–27] It consists of a blend of herbs including Angelica sinensis (24 g), Ligusticum wallichii (10 g), Prunus persica kernels (9 g), dried ginger (10 g), roasted black licorice (6 g), Patisserie (20 g), Rubia cordifolia (20 g), Leonurus japonicus (15 g), Codonopsis pilosula (10 g), Carthamus tinctorius (10 g), and Faeces togopteri (10 g).[26,27] Historically, SHD has been utilized to promote blood circulation, dispel Blood stasis, warm the Meridians, and alleviate pain, making it particularly effective in managing postpartum conditions such as PPH caused by UA and retained placenta.[23–27] The pharmacological properties of its main ingredients include A. sinensis, which provides antiinflammatory, anticoagulant, and antioxidant effects; L. wallichii, which relieves pain and promotes blood circulation; P. persica kernels, which offer anticoagulant, antiinflammatory, and analgesic properties; dried ginger, known for its antiinflammatory and hemostatic effects; and L. japonicus, which promotes uterine contraction and reduces blood loss.[23–27] This retrospective study aimed to investigate the preventive effects of SHD combined with carbetocin on PPH attributed to UA.
2. Methods
2.1. Ethic consideration
This study received approval from the local ethics committee of Affiliated Hospital of Baicheng Medical College. The necessity for informed written consent was waived given the retrospective nature of the study.
3. Study design and patients
This retrospective study was conducted at Affiliated Hospital of Baicheng Medical College. The study adhered to the principles outlined in the Declaration of Helsinki and Good Clinical Practice, ensuring the ethical treatment of human subjects in medical research. Spanning from January 2019 to December 2021, the study encompassed the identification and analysis of all cases during this period. A total of 84 eligible cases were included, subsequently divided into 2 groups – 42 patients in the treatment group and 42 in the control group. All cases were thoroughly reviewed for patient characteristics, demographics, the treatment and control modalities used, as well as the outcome endpoints.
To be eligible for inclusion in this study, women had to be between 20 and 40 years old, have singleton pregnancies, and deliver their babies vaginally between 36 and 40 gestational weeks. Exclusion criteria comprised experiencing prepartum hemorrhage, having a history of thrombosis (blood clotting disorders), in utero fetal death, prior uterine rupture, or missing important information in case records. The study design meticulously considered these factors to ensure the validity and reliability of the results. Strict adherence to inclusion and exclusion criteria aimed to minimize the impact of confounding factors, yielding more accurate and comparable data. The study also adhered to ethical considerations outlined in the Declaration of Helsinki, prioritizing the well-being and rights of research participants. In conclusion, this retrospective study at Affiliated Hospital of Baicheng Medical College involved 84 eligible cases, focusing on factors such as patient characteristics, treatment and control modalities, and outcome endpoints. Ethical guidelines and good clinical practice were observed throughout to uphold the validity and reliability of the results.
4. Treatment
All 84 patients in both groups were administered 100 μg/mL carbetocin diluted in 10 mL of saline intravenously after childbirth to prevent UA by promoting uterine contractions and reducing the risk of PPH. Additionally, patients in the treatment group received SHD to further enhance therapeutic effects and prevent PPH. They were administered 100 mL of SHD twice daily for a consecutive 7-day period. The SHD was prepared by soaking its herbal ingredients in water, followed by decoction to obtain a concentrated herbal solution. This combined approach ensured that the patients in the treatment group benefited from both the conventional pharmacological effects of carbetocin and the complementary therapeutic properties of SHD.
5. Outcome assessment
The primary endpoints comprised blood loss (mL) and alterations in hemoglobin levels (g/dL). The secondary endpoints encompassed the count of patients requiring uterine massage, the number of patients necessitating additional oxytocic drugs, pulse rate (beat/min), respiratory rate (breath/min), systolic blood pressure (mm Hg), and treatment-related adverse events.
6. Statistical analysis
This study employed SPSS (version 17.0; IBM Corp., Armonk, NY, USA) for data analysis. Descriptive summaries were generated for demographic and characteristic variables. Continuous endpoints underwent analysis using either the Student t test or the Mann–Whitney U test, while dichotomous endpoints were analyzed using the χ2 test or Fisher exact test. Statistical significance was defined as a 2-sided P-value of < .05.
7. Results
7.1. Patients characteristics
We conducted an analysis involving 84 women based on the eligibility criteria. Table 1 provides a summary of the characteristics and demographics of all included patients in both groups, revealing no significant differences in these attributes between the 2 groups (Table 1). The mean age was 27.5 (4.2) years in the treatment group and 27.1 (3.9) years in the control group. Body mass index (kg/m2), gestational age (weeks), and birth weight (g) in the treatment group were 29.2 (1.9), 38.3 (1.6), and 612.5 (346.9), respectively, while those in the control group were 29.5 (2.1), 38.1 (1.8), and 620.8 (371.0), respectively. All patients were of Chinese Asian descent, with 38 (90.5%) being Han, 3 (7.1%) Man, and 1 (2.4%) Hui in the treatment group; and 35 (83.3%) Han, 5 (11.9%) Man, and 2 (4.8%) Hui in the control group. Regarding the type of labor, the treatment group included vaginal deliveries (13 [31.0%] spontaneous, 10 [23.8%] assisted, and 19 [45.2%] cesarean deliveries), while the control group comprised vaginal deliveries (15 [35.7%] spontaneous, 5 [11.9%] assisted, and 22 [52.4%] cesarean deliveries).
Table 1.
Comparison of baseline data between 2 groups.
| Characteristics | Treatment group (n = 42) | Control group (n = 42) | P |
|---|---|---|---|
| Age (yr) | 27.5 (4.2) | 27.1 (3.9) | .65 |
| Race (Chinese Asian) | |||
| Han | 38 (90.5) | 35 (83.3) | .34 |
| Man | 3 (7.1) | 5 (11.9) | .46 |
| Hui | 1 (2.4) | 2 (4.8) | .56 |
| BMI (kg/m2) | 29.2 (1.9) | 29.5 (2.1) | .49 |
| Labor type | |||
| Vaginal delivery | |||
| Spontaneous | 13 (31.0) | 15 (35.7) | .64 |
| Assisted | 10 (23.8) | 5 (11.9) | .16 |
| Cesarean delivery | 19 (45.2) | 22 (52.4) | .51 |
| Gestational age (wk) | 38.3 (1.6) | 38.1 (1.8) | .59 |
| Birth weight (g) | 612.5 (346.9) | 620.8 (371.0) | .92 |
Note: Data are present as mean ± standard deviation or number (%); BMI = body mass index.
8. Treatment and efficacy
Regarding the primary endpoints, notable differences were observed in blood loss (mL) (treatment group, 275.7 [46.3] vs. control group, 275.7 [46.3]; P < .01, Table 2) and hemoglobin (g/dL) (treatment group, 0.7 [0.6] vs. control group, 1.1 [1.0]; P = .03, Table 2) between the 2 groups.
Table 2.
Primary endpoints.
| Endpoints | Treatment group (n = 42) | Control group (n = 42) | P |
|---|---|---|---|
| Blood loss (mL) | 294.4 (31.5) | 331.7 (25.9) | <.01 |
| Hemoglobin drop change (g/dL) | 0.7 (0.6) | 1.1 (1.0) | .03 |
Note: Data are present as mean ± standard deviation.
In terms of secondary endpoints, the pulse rate (beats/min) was 90.4 (6.2) in the treatment group, significantly higher than that of 86.8 (5.7) in the control group (P < .01, Table 3). However, there were no significant differences in the number of patients requiring uterine massage (P = .13, Table 3), the number of patients needing additional oxytocic drugs (P = .19, Table 3), respiratory rate (breaths/min) (P = .05, Table 3), and systolic blood pressure (mm Hg) (P = .80, Table 3) between the 2 groups.
Table 3.
Secondary endpoints.
| Endpoints | Treatment group (n = 42) | Control group (n = 42) | P |
|---|---|---|---|
| Need for uterine massage | 1 (2.4) | 5 (11.9) | .13 |
| Need for additional oxytocic drugs |
0 (0) | 3 (7.1) | .19 |
| Pulse rate (beat/min) | 90.4 (6.2) | 86.8 (5.7) | <.01 |
| Respiratory rate (breath/min) | 17.9 (1.7) | 17.2 (1.5) | .05 |
| Systolic blood pressure (mm Hg) | 108.4 (9.1) | 107.9 (8.9) | .80 |
Note: Data are present as mean ± standard deviation or number (%).
9. Safety
Adverse events related to the treatment are presented in Table 4. No statistically significant differences were observed in facial flushing (P = .33, Table 4), headache (P = .29, Table 4), dizziness (P = .33, Table 4), diarrhea (P = .56, Table 4), shivering (P = .29, Table 4), fever (P = .50, Table 4), nausea/vomiting (P = .56, Table 4), or fainting (P = .50, Table 4) between the 2 groups.
Table 4.
Treatment-related adverse events.
| Adverse events | Treatment group (n = 42) | Control group (n = 42) | P |
|---|---|---|---|
| Facial flushing | 1 (2.4) | 3 (7.1) | .33 |
| Headache | 0 (0) | 2 (4.8) | .29 |
| Dizziness | 1 (2.4) | 3 (7.1) | .33 |
| Diarrhea | 1 (2.4) | 2 (4.8) | .56 |
| Shivering | 0 (0) | 2 (4.8) | .29 |
| Fever | 1 (2.4) | 0 (0) | .50 |
| Nausea/vomiting | 1 (2.4) | 2 (4.8) | .56 |
| Fainting | 0 (0) | 1 (2.4) | .50 |
Note: Data are present as number (%).
10. Discussion
PPH is a common and severe complication that occurs during childbirth and can have devastating consequences if not effectively managed. If left untreated, PPH can result in a high mortality rate among women in the postpartum period. There are several risk factors that can contribute to the development of PPH, with UA being the leading cause, accounting for over 80% of all PPH cases. In an effort to prevent and reduce the incidence of PPH, prophylactic drugs such as carbetocin have been used. However, the effectiveness of carbetocin in preventing PPH remains less than satisfactory. Recently, there has been interest in exploring alternative preventive measures for PPH, including the use of traditional Chinese herbal medicine. One particular herbal remedy, known as SHD, has shown potential in benefiting women after delivery by preventing PPH. However, it is important to note that no clinical studies have been conducted to investigate the effectiveness of SHD in preventing PPH. To fill this research gap, a retrospective study was conducted to specifically examine the preventive effects of both SHD and carbetocin in the context of PPH. The study aimed to evaluate the efficacy of these interventions in reducing the occurrence of PPH and improving maternal outcomes after delivery.
Clinical evidence from prior studies substantiates the efficacy of SHD in PPH management. For instance, Hu et al conducted a study on SHD efficacy in addressing PPH associated with uterine contraction, finding significant reductions in blood loss and improvements in hemoglobin levels with SHD administration.[23] Similarly, Wan investigated the combined use of Jiawei SHD, misoprostol, and carboprost tromethamine for managing PPH attributed to UA, observing a notable decrease in blood loss, thereby underscoring SHD potential in PPH prevention.[24] Additionally, Zhao evaluated the synergistic effect of carbetocin and Biochemical Decoction in treating PPH due to UA, concluding that the combination effectively controlled PPH, indicating the advantages of integrating traditional and contemporary treatment modalities.[25]
Our retrospective analysis, comprising 84 women, demonstrated significant improvements in blood loss and hemoglobin levels in the SHD treatment group compared to the control group. These findings corroborate previous research, further emphasizing SHD potential in mitigating PPH attributed to UA. However, the absence of significant disparities in secondary outcomes, such as uterine massage and additional oxytocic drug usage, suggests that SHD may predominantly influence blood loss directly. Furthermore, the safety profile of SHD remained consistent with prior studies, showing no significant increase in adverse effects.
Regarding treatment-related adverse events, both groups exhibited similar safety profiles, suggesting that concurrent administration of SHD and carbetocin may provide a secure option for preventing PPH. Nevertheless, the retrospective nature of this study entails inherent limitations, including a small sample size and heterogeneous modality regimens. Moreover, the absence of randomization and blinding procedures raises concerns about potential bias in patient selection.
Future studies addressing these limitations through prospective randomized controlled trials with larger sample sizes are warranted to validate these findings and inform evidence-based clinical practice guidelines for PPH prevention. Additionally, comprehensive analyses of SHD mechanisms of action and potential synergistic effects with conventional interventions would contribute to a deeper understanding of its role in PPH management.
11. Conclusion
The findings from this retrospective study suggest that the combination of SHD and carbetocin may yield promising preventive effects on PPH. Nevertheless, it is crucial to note that further studies are required to validate and substantiate the current findings. Ongoing research will help ensure the reliability and generalizability of the observed preventive effects and contribute to a more comprehensive understanding of the potential benefits of this combined intervention.
Author contributions
Conceptualization: Xi-Wen Yu, Cheng-Si Wang, Gui-Mei Zhang.
Data curation: Xi-Wen Yu, Cheng-Si Wang, Gui-Mei Zhang.
Formal analysis: Cheng-Si Wang.
Investigation: Gui-Mei Zhang.
Methodology: Xi-Wen Yu, Cheng-Si Wang.
Project administration: Gui-Mei Zhang.
Resources: Xi-Wen Yu, Cheng-Si Wang.
Software: Cheng-Si Wang.
Supervision: Gui-Mei Zhang.
Validation: Xi-Wen Yu, Cheng-Si Wang, Gui-Mei Zhang.
Visualization: Xi-Wen Yu, Cheng-Si Wang, Gui-Mei Zhang.
Writing—original draft: Xi-Wen Yu, Cheng-Si Wang, Gui-Mei Zhang.
Writing—review & editing: Xi-Wen Yu, Cheng-Si Wang, Gui-Mei Zhang.
Abbreviations:
- PPH
- postpartum hemorrhage
- SHD
- Shenghua decoction
- UA
- uterine atony
The authors have no funding and conflicts of interest to disclose.
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: Yu X-W, Wang C-S, Zhang G-M. Shenghua decoction for postpartum hemorrhage attributed to uterine atony: An observational study. Medicine 2024;103:34(e39351).
XWY and CSW contributed equally to this study.
Contributor Information
Xi-Wen Yu, Email: 1170861406@qq.com.
Cheng-Si Wang, Email: 2463523647@qq.com.
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