Clinical effects of uterine artery embolization combined with Mifepristone and Ethacridine Lactate in induction of labor for placenta previa

doi:10.21203/rs.3.rs-2958965/v1

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Clinical effects of uterine artery embolization combined with Mifepristone and Ethacridine Lactate in induction of labor for placenta previa

https://doi.org/10.21203/rs.3.rs-2958965/v1

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Objective

To investigate the clinical efficacy of uterine artery embolization combined with mifepristone and levonorgestrel in the induction of labor for placenta previa.

Methods

A total of 108 high-risk pregnant women with placenta previa who underwent induction of labor were enrolled in this study from January 2018 to June 2022. They were randomly divided into two groups: the intervention group (n = 51) received uterine artery embolization combined with mifepristone and levonorgestrel amniocentesis injection for induction of labor, while the control group (n = 57) received oral mifepristone and levonorgestrel amniocentesis injection for induction of labor as a comparison. The induction time, blood loss during and after induction, and complications were compared between the two groups. Throughout the study, all procedures adhered strictly to the ethical principles outlined in the Helsinki Declaration. No intervention-related complications occurred during the follow-up period.

Results

Among the 57 cases in the control group, 55 cases (96.49%) delivered vaginally, 25 cases (43.85%) had postpartum hemorrhage, and 2 cases (3.50%) underwent emergency cesarean section due to bleeding volume reaching 1000 ml. All 51 cases (100%) in the intervention group delivered vaginally, and 6 cases had postpartum hemorrhage. The induction time in the control group was (25.296 ± 1.6303), while the induction time in the intervention group was (21.753 ± 0.5334), and the difference was statistically significant (P < 0.01). The total hospital stay after induction of labor in the control group was (5.767 ± 1.2977), while the total hospital stay after induction of labor in the intervention group was (4.169 ± 0.5771), and the difference was statistically significant (P < 0.01).

Conclusion

In placenta previa induction of labor, uterine artery embolization combined with mifepristone and levonorgestrel can effectively reduce blood loss during induction, shorten induction duration, improve induction success rate, and reduce the risk of cesarean section during induction. It can also protect the uterus and prevent placental adhesion, ensuring the safety of pregnant women. It is a safe, minimally invasive, and effective method that deserves clinical promotion.

Health sciences/Diseases

Health sciences/Medical research

placenta previa

induction of labor

uterine artery embolization

mifepristone

ethacridine lactate

Since the implementation of the two-child policy in China, the cesarean section rate has also increased year by year. Placenta previa and placenta previa status have a high incidence rate in China, which is related to the high cesarean section rate. Of course, apart from cesarean section, repeated intrauterine operations and multiple deliveries can also cause damage to the uterus, and endometrial lesions can increase the incidence rate of placenta previa.

Placenta previa status refers to a condition where the edge of the placenta is close to, reaches or covers the cervical os before 28 weeks of gestation[1–3]. In placenta previa status pregnancy, the placenta is attached to the lower segment of the uterus, and the attachment site is often lower than the presenting part. The blood vessels and blood sinuses at the attachment site are very rich, and during induction of labor, compression of the placenta by the presenting part can easily cause premature placental abruption and massive bleeding. Therefore, massive bleeding is prone to occur during induction of labor for placenta previa status, resulting in poor maternal outcome[4, 5]. At present, there is still no clear consensus on the best method of induction for mid-trimester placenta previa status, which is a hot spot and difficulty in obstetric research.

Clinically, when we deal with placenta previa status induction of labor, especially for those with a history of cesarean section who have mid-trimester placenta previa status induction of labor, we usually use cesarean section or drug induction of labor to terminate the pregnancy. Although cesarean section can reduce the risk of massive bleeding in pregnant women, it requires cesarean section to deliver the fetus, which will also increase the risk of scar pregnancy, placenta previa, etc. Drug induction of labor, which is the common use of mifepristone and levonorgestrel for induction of labor, but there are few reports on the use of drug induction of labor for placenta previa status. Drug-induced labor has a high risk of bleeding, poor prognosis, and more complications after bleeding. At present, there is no clear consensus on the optimal method of induction for mid-trimester placenta previa status in clinical practice. Therefore, exploring how to reduce the risk of induction injury for placenta previa status is a key issue.

In human anatomy, we can know that the blood supply of the uterus mainly comes from the bilateral internal iliac artery and ovarian artery. Therefore, during induction of labor, blocking most of the blood supply to the uterus can reduce the risk of bleeding. After interventional treatment entered the field of obstetrics and gynecology treatment, this problem was well solved. In the 1990s, uterine artery embolization (UAE) began to be applied to obstetric hemorrhage intervention. Uterine artery embolization blocked the blood supply source of the uterus and reduced obstetric postpartum hemorrhage and other hemorrhagic diseases, reducing the probability of hysterectomy due to massive hemorrhage[6, 7].

In this study, we collected 108 high-risk pregnant women with placenta previa status who underwent induction of labor in our hospital from January 2018 to June 2022 as research subjects. They were randomly divided into two groups: the intervention group (n = 51) received uterine artery embolization combined with mifepristone and levonorgestrel amniocentesis injection for induction of labor. The other 57 cases were compared with oral mifepristone and levonorgestrel amniocentesis injection for induction of labor. The induction time, blood loss during and after induction, and complications were compared between the two groups. No intervention-related complications occurred during the follow-up period. The results showed that uterine artery embolization combined with mifepristone and levonorgestrel amniocentesis injection for induction of labor had less bleeding during induction, shorter induction time, fewer complications, and effectively controlled perinatal blood loss. It also improved prognosis, increased induction success rate, reduced cesarean section rate and placental adhesion, ensured maternal safety, and had safe operation, minimal trauma, and achieved expected goals. It is worth clinical promotion.

Subject

A total of 108 high-risk pregnant women who underwent induction of labor for anterior placenta previa between January 2018 and June 2022 at our hospital were included in this study. They were randomly divided into two groups: the study group (n = 51) received uterine artery embolization combined with intramembranous injection of mifepristone and levonorgestrel for labor induction, while the comparison group (n = 57) underwent oral administration of mifepristone and intramembranous injection of levonorgestrel for labor induction. All participants had normal findings on pre-induction examinations, and they were informed about the potential risks associated with different induction methods and provided written informed consent. This study has been reviewed and approved by the Medical Research and Clinical Trial Ethics Committee of the School of Medical Sciences, Baise People's Hospital (Approval No: KY2021072501), ensuring compliance with the ethical principles outlined in the Helsinki Declaration.

Inclusion and exclusion criteria

Inclusion criteria:

(1) Diagnosed as placenta previa or placenta previa status by ultrasound, magnetic resonance imaging and other imaging examinations; (2) Gestational age 18–36 weeks, requiring termination of pregnancy.

Exclusion criteria:

(1) Other contraindications to vaginal delivery; (2) High risk of uterine rupture; (3) Stillbirth or multiple pregnancy; (4) Highly suspected or confirmed placenta accreta or placenta increta by imaging examination; (5) Allergic to drugs used in this study.

Methods

Informed consent

was obtained from all human participants, and the study adhered strictly to the ethical principles outlined in the Helsinki Declaration. Prior to the procedures, blood was prepared for all participants, and emergency plans were established. The specific methods for each group were as follows:

Uterine artery embolization with medication induction group: One day before the intramembranous injection, participants orally received 200mg of mifepristone (manufactured by Shanghai Pharmaceuticals Co., Ltd.). Then, levonorgestrel (manufactured by Jiangsu Desano Pharmaceutical Co., Ltd.) was injected intramembranously. Within 24 hours, prophylactic uterine artery embolization was performed under local anesthesia. Using the Seldinger technique, a catheter was inserted into the femoral artery, and with the guidance of digital subtraction angiography, 1500–1800µm gelatin sponge particles were slowly infused into both uterine arteries until the main uterine artery blood flow stagnated and complete disappearance of placental vascular staining was achieved.

Medication induction group: One day before the intramembranous injection, participants orally received mifepristone. Following the intramembranous injection, participants were administered misoprostol (manufactured by CR Zizhu Pharmaceutical Co., Ltd.) based on uterine contraction response until regular contractions occurred. In cases where the amount of bleeding during induction exceeded 500ml, emergency uterine artery embolization was performed..

Observation indicators

(1) Compare the general data of the two groups such as: previous pregnancies, previous deliveries, previous abortions, gestational weeks, previous history of placenta previa, etc. (2) Induction time, control group and intervention group, induction time from oral mifepristone to fetal and placental expulsion. (3) Blood loss during induction, control group and intervention group blood loss from oral mifepristone to fetal and placental expulsion, using area method, volume method, weighing method to calculate blood loss. (4) Record the time from induction to discharge for both groups, whether there are any complications, whether cesarean section is required during induction.

Statistical method

SPSS 26.0 statistical software package was used for data processing. Measurement data were expressed as (x ± s), and variance analysis was used for comparison among three groups, and t-test was used for comparison between groups; count data were expressed as (%), and X² test was used. P < 0.05 indicated that the difference was statistically significant.

General clinical data

There was no significant difference (P > 0.05) in age, previous pregnancies, deliveries, abortions, gestational weeks, history of placenta previa, etc. between the two groups .(see Table 1 for details)

Table 1

Comparison of obstetric history between two groups of pregnant women
Group	Age	Pregnancies	Deliveries	Gestational weeks	History of placenta previa (T/F)
Study group (n = 51)	26.804 ± 6.3593	3.25 ± 1.440	1.65 ± 0.483	25.510 ± 3.5630	9/51
Control group (n = 57)	28.667 ± 6.8042	3.19 ± 1.407	1.47 ± 0.504	27.070 ± 4.2589	11/57
t/x²	21.457	2.033	3.277	17.169	0.049
p	0.431	0.845	0.07	0.192	0.825
* Indicates x²

Delivery outcomes

Among the 57 cases in the control group, 55 cases (96.49%) delivered vaginally, 25 cases (43.85%) had postpartum hemorrhage, and 2 cases (3.50%) underwent emergency cesarean section due to bleeding volume reaching 500ml after uterine artery embolization. The vaginal bleeding did not improve significantly after the operation, and the bleeding volume exceeded 1000ml. All 51 cases (100%) in the intervention group delivered vaginally, and 6 cases had postpartum hemorrhage.

Induction of labor

The time of fetal expulsion in the control group was (25.296 ± 1.6303), and the time of fetal expulsion in the intervention group was (21.753 ± 0.5334), and the difference was statistically significant (P < 0.01). (see Table 2 for details)

Post-induction hospitalization time

The total post-induction hospitalization time in the control group was (5.767 ± 1.2977), and the total post-induction hospitalization time in the intervention group was (4.169 ± 0.5771), and the difference was statistically significant (P < 0.01). (see Table 2 for details)

Table 2

Comparison of obstetric history between two groups of pregnant women
Group	Number of postpartum hemorrhages	Hospital stay time	stillbirth expulsion time	Cesarean section	average postpartum bleeding loss(ml)
Study group (n = 51)	6	4.169 ± 0.5771	21.753 ± 0.5334	0	38.65 ± 39.860
Control group (n = 57)	25	5.767 ± 1.2977	25.296 ± 1.6303	2	310.79 ± 471.395
t/x²	13.548	65.593	101.58	1.823	4.108
p	< 0.001	0.007	< 0.001	0.177	< 0.001
* Indicates x²

Placenta previa mainly reflects the relationship between the placenta and the cervical os. At 16–18 weeks of gestation, the placenta is basically developed, and its area accounts for nearly half of the total area of the uterine cavity, which is a period of increased incidence of placenta previa status. Placenta previa refers to the attachment of the placenta to the lower segment of the uterus after 28 weeks of gestation, or even reaching or covering the cervical os, and its position is lower than that of the presenting part[8, 9]. Placenta previa status or placenta previa can easily induce massive hemorrhage, amniotic fluid embolism and other fatal complications during induction of labor or cesarean section[10–12]. Especially when placenta previa is complicated by placental implantation, it often endangers the life of pregnant women due to uncontrollable hemorrhage, and hysterectomy is required when hemorrhage cannot be controlled[13]. At present, for mid- and late-term placenta previa status or placenta previa induction methods, oral mifepristone combined with amniocentesis levonorgestrel injection followed by vaginal delivery or direct cesarean section are commonly used in clinical practice[13].

Mifepristone can endogenously compete with progesterone receptors during drug induction, causing degeneration and necrosis of decidual cells and villous tissue, inducing apoptosis of trophoblast cells, inhibiting their proliferation, increasing the sensitivity of uterine muscle layer to prostaglandins, thereby leading to uterine contraction and reduced uterine and placental blood flow, while also causing cervical collagen fiber degradation, cervical softening and dilation, which is conducive to fetal and placental expulsion[14–18]. In addition, levonorgestrel injection into the amniotic cavity can cause degeneration and necrosis of decidual tissue and placenta in pregnant women, promote prostaglandin secretion increase, facilitate uterine contraction, cervical dilation, fetal and placental delivery[19, 20]. The combination of mifepristone and levonorgestrel for mid-term induction of labor in pregnant women can further reduce placental blood supply under the synergistic effect of two drugs, which is conducive to fetal and accessory expulsion as soon as possible, reduce maternal intrapartum and postpartum hemorrhage rate[21, 22]. Jiang Qianying et al[23] studied 95 cases of mid-term pregnant women with placenta previa status, who were induced by mifepristone combined with levonorgestrel (study group) or terminated pregnancy by cesarean section (control group), respectively. There were no cases of drug-induced conversion to cesarean section in the study group. Chen et al[21] induced 128 cases of mid-term pregnant women with placenta previa status (with or without scarred uterus) with mifepristone combined with levonorgestrel, all of which were successful. In this study, both groups were able to induce vaginal delivery after using mifepristone combined with amniocentesis levonorgestrel injection, with only 2 cases converted to cesarean section delivery, which preliminarily indicates that mifepristone combined with amniocentesis levonorgestrel injection induction is feasible.

Since Brown et al used uterine artery embolization to successfully treat postpartum hemorrhage in 1979, interventional embolization therapy has made a great contribution to saving the uterus of obstetric postpartum hemorrhage patients, preserving life, and improving patient satisfactio[24]. Uterine artery embolization is to insert a catheter selectively into the uterine artery and inject methotrexate and gelatin sponge. Fresh gelatin sponge particles are absorbable medium-effect embolic agents, which can be absorbed by blood vessels within 2–3 weeks after embolization, and blood vessels recanalize; and they can only embolize to the distal arteries, not embolize the pre-capillary arteries and capillary bed, ensuring the patency of the collateral circulation of the capillary small arteries, so that the pelvic organs such as uterus, bladder, rectum can obtain a small amount of blood supply, without causing pelvic organ necrosis. Uterine artery embolization significantly reduces the amount of bleeding during induction of labor in patients with mid-term pregnancy placenta previa status, preserves the uterus and reduces long-term complications. UAE has been used to treat uterine bleeding with good results[25–27]. It stops bleeding by blocking the main blood supply of the uterus.

For complete placenta previa induction of labor preventive use of uterine artery embolization, we believe that there are also the following advantages: (1) improve the success rate of embolization: preventive uterine artery embolization ensures that the operation time will not be delayed due to rescue, nor will it cause prolonged operation time or failure due to poor psychological quality of doctors, increasing patient bleeding. It has been reported that the success rate of preventive uterine artery embolization is 100%, while that of emergency operation is 88%. (2) increase the success rate of induction: uterine artery embolization causes hypoxic uterine contraction and fetal death, which promotes induction. (3) reduce placental adhesion: uterine artery embolization can reduce placental adhesion, and even separate some implanted placenta from the uterine wall. In this experiment, among 57 cases in the control group, 55 cases (96.49%) delivered vaginally directly, 25 cases (43.85%) had postpartum hemorrhage, and 2 cases (3.50%) underwent emergency cesarean section due to bleeding volume reaching 500ml after uterine artery embolization. The vaginal bleeding did not improve significantly after the operation, and the bleeding volume exceeded 1000ml. All 51 cases (100%) in the intervention group delivered vaginally, and 6 cases had postpartum hemorrhage. The results of this study show that the experimental group used embolic agents to block the blood supply of the uterus, thereby reducing the arterial pressure of the intramural vessels and achieving hemostasis and prevention of uterine massive hemorrhage.

The patients in the observation group had less postpartum hemorrhage induced by induction than those in the control group. The possible reasons may be related to the following factors: (1) Uterine artery embolization can cause uterine contraction and block placental blood flow, inducing and promoting abortion; (2) Uterine artery embolization directly blocks uterine arteries, which can slow down or stop uterine arterial blood flow, which is conducive to reducing patient blood loss. Previously, Wang Kai et al[28] confirmed that uterine artery embolization can effectively reduce blood loss in patients undergoing induction of labor, and can promote induction progress. On one hand, the results of this study suggest that uterine artery embolization combined with drug induction does not increase postoperative complications in patients, and has good safety.

After bilateral UAE, the pregnancy tissue is in a state of ischemia and hypoxia, the activity of trophoblastic cells is reduced, the villous tissue is destroyed, and embryonic development is prevented. Relevant clinical evidence shows that uterine artery embolization effectively reduces the difficulty of curettage and can promote the necrosis and absorption of residual villous tissue after surgery. In addition, methotrexate injected by uterine artery embolization maintains a high perfusion locally, while the systemic tissue is in a low concentration state, avoiding methotrexate from killing the embryo while damaging other organs of the mother. In this study, the time of fetal expulsion in the control group was (25.296 ± 1.6303), and the time of fetal expulsion in the intervention group was (21.753 ± 0.5334), and the difference was statistically significant (P < 0.01). The results show that uterine artery embolization causes uterine ischemia, fetal death, and can induce labor onset.

Some studies have shown that the short-term complications of uterine artery embolization are mainly pain and fever. The long-term complications of uterine artery embolization are mainly related to the impact on ovarian function and fertility [29]. The short-term complications of embolization are related to ischemia, edema, necrosis, exudation of inflammatory substances and toxin absorption of embolized tissues, and are mostly related to the type and particle size of embolic agents. The smaller the particles, the larger the embolization range, and the more severe the postoperative short-term complications. In this study, the total post-induction hospitalization time in the control group was (5.767 ± 1.2977), and the total post-induction hospitalization time in the intervention group was (4.169 ± 0.5771), and the difference was statistically significant (P < 0.01). No obvious short-term complications were found in this study, and the total post-induction hospitalization time in the intervention group was less than that in the control group. However, this study has some limitations, such as small sample size, and maternal fever is still related to blood loss volume to some extent, which cannot explain whether it is a short-term complication caused by uterine artery embolization alone. Moreover, the occurrence of complications related to embolization is largely related to the operator's operation skills and clinical experience. Therefore, uterine artery embolization treatment requires close cooperation between interventional physicians and obstetricians and gynecologists. Not only does it require interventional physicians to constantly improve their operation skills and theoretical understanding, but also to be more accurate, effective, and minimize the error rate as much as possible. At the same time, it also requires obstetricians and gynecologists to strictly grasp the indications for uterine artery embolization, especially for women who have fertility needs. They must thoroughly analyze the condition, individualize treatment, weigh the pros and cons, prescribe according to symptoms, and prevent overtreatment.

Current studies have shown that using drug induction while using uterine artery embolization has become a new way of mid-term pregnancy induction of labor. It can block uterine blood supply while inducing labor, reduce uterine bleeding, effectively prevent massive hemorrhage, and play an important role in improving induction success rate, reducing cesarean section and hysterectomy risk. The results of this study show that both drug group and uterine artery embolization combined with drug observation group have higher total induction effectiveness than control group using drug induction alone. The induction process time, induction bleeding volume during induction and after induction, postoperative hospitalization days were all lower than those in control group ,and induction conversion cesarean section incidence rate were all lower than those in control group. This result is consistent with many domestic literature reports. It shows that adding uterine artery embolization can effectively reduce bleeding during placenta previa induction process, improve induction success rate, reduce cesarean section risk, confirm uterine artery embolization for mid-term pregnancy induction effectiveness and feasibility.

Acknowledgements

The author thanks the partners who participated in the work of this study.

Authors' contributions

All authors contributed to the study conception and design. Designed the study were performed by Pan Chun-hong and Wei Xiu-ling. Data analysis were performed by Cen Bing-kui, Wu Yu-hua , Wei Yu-lan and Wei Xiu-ling. The first draft of the manuscript was written by Pan Chun-hong and Wei Xiu-ling. All authors read and approved the final manuscript.

Competing interests

The authors declare that they have no conflict of interests.

Availability of data and materials

All data generated or analyzed during this study are included in this published article.

Ethics declarations

Not Applicable.

Funding

This study was supported by Guangxi Zhuang Autonomous Region Baise City School Science and Technology Cooperation Project (NO.20170812)

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No competing interests reported.

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Clinical effects of uterine artery embolization combined with Mifepristone and Ethacridine Lactate in induction of labor for placenta previa

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Abstract

Objective

Methods

Results

Conclusion

Introduction

Materials and methods

Subject

Inclusion and exclusion criteria

Inclusion criteria:

Exclusion criteria:

Methods

Observation indicators

Statistical method

Results

General clinical data

Delivery outcomes

Induction of labor

Post-induction hospitalization time

Discussion

Declarations

Acknowledgements

Authors' contributions

Competing interests

Availability of data and materials

Ethics declarations

Funding

References

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