Real-world utilization pattern of dydrogesterone in 7287 Indian women with obstetric and gynecological conditions: data from multicentric, retrospective study

Abstract Objective: Despite the literature on dydrogesterone, studies on dydrogesterone utilization patterns are largely lacking in Indian patients. Methods: This was a multi-center, retrospective, observational, cross-sectional, and descriptive study across 817 centers in India. Data of patients who received dydrogesterone in past and provided consent for future use of their medical record for research purpose was were retrieved and analyzed. Results: Data of 7287 subjects (aged 29.55±4.84 years) was analyzed. Threatened abortion was the most common indication for which the subjects received dydrogesterone (46.9%) followed by recurrent pregnancy loss. Polycystic ovary syndrome (PCOS), thyroid disorders and anemia were the most common comorbid conditions and prior pregnancy loss, advanced maternal age and obesity were the most common risk factors seen in subjects who received dydrogesterone. Total 27.5% of subjects received a loading dose of dydrogesterone, and majority (64%) received 40 mg as loading dose. 10 mg dose was used as maintenance or regular dose in 81.4% of the subjects. Twice daily (BID) was the most common dosing frequency (66.6%). The most common concomitant medications being taken by the subjects on dydrogesterone included folic acid (45.1%), iron supplements (30.3%) and calcium and vitamin D3 supplements (25.5%). Another progesterone preparation (oral, injection, vaginal, tubal) other than dydrogesterone was used concurrently in 7.8% of subjects. Conclusion: The study helped to identify the patient population that is benefitted by dydrogesterone and the preferred indications, risk factors, comorbid conditions and concomitant medication used in this patient population at real-life scenario.

The effect of progesterone supplementation in women with threatened miscarriage on fetal fraction in non-invasive prenatal testing: A matched case-control study.

AIM: To evaluate the effect of progesterone use on fetal fraction (FF) in non-invasive prenatal testing (NIPT) due to the threat of first trimester miscarriage. METHODS: This case control study included the pregnant who were referred to our clinic for non-invasive prenatal testing. The patients were categorized into three groups: Pregnant women with vaginal bleeding and using progesterone, pregnant women with vaginal bleeding and not using progesterone, and pregnant women without bleeding. The groups were formed by matching gestational week. Women with multiple pregnancy, BMI (body mass index) ≥25, abnormal fetal karyotype, and chronic disease were excluded from the study. Maternal characteristics, FF of the NIPT were recruited from the computer based medical records. RESULTS: A total of 10,275 NIPT tests were performed during the study period. 3% of the patients (n = 308) were found at risk of miscarriage. 100 patients with a vaginal bleeding and 50 control patients were matched. The median value of the fetal fraction ratio was found to be 6.55 in pregnant women without vaginal bleeding, 7.05 in pregnant women who had vaginal bleeding and using progesterone, and 7.3 in pregnant women who had vaginal bleeding and did not use progesterone. Although the fetal fraction ratio was found to be higher in pregnant women with vaginal bleeding and lower in progesterone users, this situation could not reach the level of statistical significance (p = 0.351). CONCLUSIONS: The fetal fraction rate in maternal blood is not affected in pregnant women who use progesterone due to vaginal bleeding in early gestational weeks.

Shoutai Wan regulates glycolysis imbalance at the maternal-fetal interface in threatened abortion mice.

ETHNOPHARMACOLOGICAL RELEVANCE: Threatened abortion is a common disease among women of childbearing age. Its high incidence rate and unclear etiology, seriously threaten women's physical and mental health. Shoutai Wan (STW) is a traditional Chinese medicine decoction for treating abortion. It has a long history of treating threatened abortion by tonifying the kidney and calming the fetus. However, the mechanism of STW remains unclear. AIM OF STUDY: To study the mechanism and potential benefit of STW in pregnant mice with hydrocortisone and mifepristone-induced threatened abortion. MATERIALS AND METHODS: The STW compounds were identified using gas chromatography-mass spectrometry analysis. STW-H, STW-M, or STW-L was separately given 3 mg/ml, 1.5 mg/ml and 0.75 mg/ml STW in the morning, and 2 mg/ml hydrocortisone in the afternoon from gestation day (D) 1-9 and once with 0.4 mg/kg mifepristone on D10. Didroxyprogesterone (0.1 mg/ml) and equal dose pure water were used to replace STW in didroxyprogesterone (DYD) group and model group respectively. The control group used pure water to replace STW, hydrocortisone, and mifepristone. We performed morphological and histological analyses of the maternal-fetal interface on day 10. RESULTS: The embryo loss rate in the STW-H and DYD groups was lower than that in the model group. Hematoxylin and eosin (HE) staining suggested that the morphology of maternal-fetal interface was improved in the STW-H and DYD groups. Immunohistochemical (IHC), Quantitative Reverse Transcription Polymerase Chain Reactionstaining (qRT-PCR), and Western blot (WB) results indicated that HIF-1α expression in the maternal-fetal interface of the STW-H and DYD groups was higher than that in model group. The activities of HK, PKM, LDH and the concentration of lactic acid in the STW-H and DYD groups were higher than those in model group. Furthermore, the protein and mRNA levels of HK2, PKM2, LDHA, MCT4, and GPR81 were higher in the STW-H and DYD groups than those in the model group. CONCLUSIONS: STW can reduce the pregnancy loss rate by regulating the glycolysis balance at the maternal-fetal interface of kidney deficiency threatened abortion model mice.

Shoutai pills for threatened abortion: A protocol for systematic review and meta-analysis.

BACKGROUND: Threatened abortions are a serious health risk for women. Deferiprone tablets are commonly used in the treatment of clinical delivery. Traditional Chinese medicine, a characteristic medical system inherited for thousands of years, often applies Shoutai pills in the treatment of Threatened abortion and has achieved good results. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Shoutai pills combined with dedrogesterone tablets for the treatment of early preterm abortion. METHODS: Electronic searches of clinical randomized controlled trials in PubMed, Web of Science, MEDLINE, EMBASE, China National Knowledge Infrastructure, Wanfang database, and China Scientific Journal Database (VIP) were conducted. References to the included literature, gray literature in Open Grey, and other relevant literature such as clinical studies registered in ClinicalTrials.gov, were also manually searched. Relevant data were extracted, and a meta-analysis was performed using Reviewer Manager 5.4. RESULTS: The results of this study will be submitted to peer-reviewed journals. CONCLUSION: This study provides high-quality evidence on the efficacy and safety of Shoutai pills in combination with dedrogesterone tablets for the treatment of preterm abortion.

Intervenções psicológicas necessárias: a prática como residente no serviço de medicina fetal / Necessary psychological interventions: the practice as a resident in the fetal medicine service / Intervenciones psicológicas necesarias: la práctica como residente en el servicio de medicina fetal

Com os avanços tecnológicos e o aprimoramento da prática médica via ultrassonografia, já é possível detectar possíveis problemas no feto desde a gestação. O objetivo deste estudo foi analisar a prática do psicólogo no contexto de gestações que envolvem riscos fetais. Trata-se de um estudo qualitativo sob formato de relato de experiência como psicólogo residente no Serviço de Medicina Fetal da Maternidade Escola da Universidade Federal do Rio de Janeiro (UFRJ). Os registros, feitos por observação participante e diário de campo, foram analisados em dois eixos temáticos: 1) intervenções psicológicas no trabalho em equipe em consulta de pré-natal, exame de ultrassonografia e procedimento de amniocentese; e 2) intervenções psicológicas em casos de bebês incompatíveis com a vida. Os resultados indicaram que o psicólogo nesse serviço é essencial para atuar de forma multiprofissional na assistência pré-natal para gravidezes de alto risco fetal. Ademais, a preceptoria do residente é relevante para sua formação e treinamento para atuação profissional no campo da psicologia perinatal.(AU)

Face to the technological advances and the improvement of medical practice via ultrasound, it is already possible to detect possible problems in the fetus since pregnancy. The objective of this study was to analyze the psychologist's practice in the context of pregnancies which involve fetal risks. It is a qualitative study based on an experience report as a psychologist trainee at the Fetal Medicine Service of the Maternity School of UFRJ. The records, based on the participant observation and field diary, were analyzed in two thematic axes: 1) psychological interventions in the teamwork in the prenatal attendance, ultrasound examination and amniocentesis procedure; and 2) psychological interventions in cases of babies incompatible to the life. The results indicated that the psychologist in this service is essential to work in a multidisciplinary way at the prenatal care for high fetal risk pregnancies. Furthermore, the resident's preceptorship is relevant to their education and training for professional performance in the field of Perinatal Psychology.(AU)

Con los avances tecnológicos y la mejora de la práctica médica a través de la ecografía, ya se puede detectar posibles problemas en el feto desde el embarazo. El objetivo de este estudio fue analizar la práctica del psicólogo en el contexto de embarazos de riesgos fetal. Es un estudio cualitativo basado en un relato de experiencia como residente de psicología en el Servicio de Medicina Fetal de la Escuela de Maternidad de la Universidade Federal do Rio de Janeiro (UFRJ). Los registros, realizados en la observación participante y el diario de campo, se analizaron en dos ejes temáticos: 1) intervenciones psicológicas en el trabajo en equipo, en la consulta prenatal, ecografía y los procedimientos de amniocentesis; y 2) intervenciones psicológicas en casos de bebés incompatibles con la vida. Los resultados señalaron como fundamental la presencia del psicólogo en este servicio trabajando de forma multidisciplinar en la atención prenatal en el contexto de embarazos de alto riesgo fetal. Además, la tutela del residente es relevante para su educación y formación para el desempeño profesional en el campo de la Psicología Perinatal.(AU)

Percepção sobre o cuidado à perda gestacional: estudo qualitativo com casais brasileiros / Perceptions on pregnancy loss care: a qualitative study with brazilian couples / Percepción sobre la atención a la pérdida del embarazo: estudio cualitativo con parejas brasileñas

Este artigo analisou a percepção e os sentimentos de casais sobre o atendimento recebido nos serviços de saúde acessados em função de perda gestacional (óbito fetal ante e intraparto). O convite para a pesquisa foi divulgado em mídias sociais (Instagram e Facebook). Dos 66 casais que contataram a equipe, 12 participaram do estudo, cuja coleta de dados ocorreu em 2018. Os casais responderam conjuntamente a uma ficha de dados sociodemográficos e uma entrevista semiestruturada, realizada presencialmente (n=4) ou por videochamada (n=8). Os dados foram gravados em áudio e posteriormente transcritos. A Análise Temática indutiva das entrevistas identificou cinco temas: sentimento de impotência, iatrogenia vivida nos serviços, falta de cuidado em saúde mental, não reconhecimento da perda como evento com consequências emocionais negativas, e características do bom atendimento. Os achados demonstraram situações de violência, comunicação deficitária, desvalorização das perdas precoces, falta de suporte para contato com o bebê falecido e rotinas pouco humanizadas, especialmente durante a internação após a perda. Para aprimorar a assistência às famílias enlutadas, sugere-se qualificação profissional, ampliação da visibilidade do tema entre diferentes atores e reorganização dos serviços, considerando uma diretriz clínica para atenção ao luto perinatal, com destaque para o fortalecimento da inserção de equipes de saúde mental no contexto hospitalar.(AU)

This study analyzed couples' perceptions and feelings about pregnancy loss care (ante and intrapartum fetal death). A research invitation was published on social media (Instagram and Facebook) and data collection took place in 2018. Of the 66 couples who contacted the research team, 12 participated in the study by filling a sociodemographic questionnaire and answering a semi-structured interview in person (n=04) or by video call (n=08). All interviews were audio recorded, transcribed, and examined by Inductive Thematic Analysis, which identified five themes: feelings of impotence, iatrogenic experiences in health services, lack of mental health care, not recognizing pregnancy loss as an emotionally overwhelming event, and aspects of good healthcare. Analysis showed experiences of violence, poor communication, devaluation of early losses, lack of support for contact with the deceased baby, and dehumanizing routines, especially during hospitalization after loss. Professional qualification, extended pregnancy loss visibility among different stakeholders, and reorganization of health services are needed to improve the care offered to grieving families, considering a clinical guideline for perinatal grief care with emphasis on strengthening the insertion of mental health teams in the hospital context.(AU)

Este estudio analizó las percepciones y sentimientos de parejas sobre la atención recibida en los servicios de salud a los que accedieron debido a la pérdida del embarazo (muerte fetal ante e intraparto). La invitación al estudio se publicó en las redes sociales (Instagram y Facebook). De las 66 parejas que se contactaron con el equipo, 12 participaron en el estudio, cuya recolección de datos se realizó en 2018. Las parejas respondieron un formulario de datos sociodemográficos y realizaron una entrevista semiestructurada presencialmente (n=4) o por videollamada (n=08). Los datos se grabaron en audio para su posterior transcripción. El análisis temático inductivo identificó cinco temas: Sentimiento de impotencia, experiencias iatrogénicas en los servicios, falta de atención a la salud mental, falta de reconocimiento de la pérdida como un evento con consecuencias emocionales negativas y características de buena atención. Los hallazgos evidenciaron situaciones de violencia, comunicación deficiente, desvalorización de las pérdidas tempranas, falta de apoyo para el contacto con el bebé fallecido y rutinas poco humanizadas, especialmente durante la hospitalización tras la pérdida. Para mejorar la atención a las familias en duelo, se sugiere capacitación profesional, ampliación de la visibilidad del tema entre los diferentes actores y reorganización de los servicios, teniendo en cuenta una guía clínica para la atención del duelo perinatal, enfocada en fortalecer la inserción de los equipos de salud mental en el contexto hospitalario.(AU)

Stress, anxiety, intolerance of uncertainty, and psychological well-being characteristics of pregnant women with and without threatened miscarriage: a case-control study.

The aim of this study was to examine the stress, anxiety, intolerance of uncertainty, and psychological well-being of pregnant women with and without threatened miscarriage. This is a case-control study. The research was carried out between January 2022 and March 2022 in the early pregnancy service and obstetrics clinic of the only training and research hospital in a province in the Central Anatolian Region of Turkey. Two hundred and one pregnant women with threatened miscarriage constituted the study group and 201 pregnant women without threatened miscarriage constituted the control group. A total of 402 pregnant women were included in the study. Stress, anxiety, and intolerance of uncertainty were found to be important risk factors affecting the psychological well-being of pregnant women with threatened miscarriage at a rate of 52% (F = 63,196, p < 0.001). In addition, the pregnant women with threatened miscarriage had higher levels of stress, anxiety, and intolerance of uncertainty, and their psychological well-being was considerably lower compared to pregnant women without threatened miscarriage (p < 0.05). There was a moderate and negative relationship between psychological well-being and intolerance of uncertainty (p < 0.05). It was determined that stress, anxiety, and uncertainty of pregnant women with threatened miscarriage were considerably higher compared to controls, and their psychological well-being was adversely affected. Health professionals should evaluate the levels of anxiety, stress, intolerance of uncertainty, and psychological well-being of pregnant women, especially in the routine follow-up of pregnant women with threatened miscarriage, and they should provide holistic care, not only physiologically but also bio-psychosocially.IMPACT STATEMENTWhat is already known on this subject? Although there are many studies on the emotional and psychological effects of miscarriage, there are limited studies on the effect of threatened miscarriage on the mental health of pregnant women.What do the results of this study add? Stress, anxiety, and intolerance to uncertainty were found to be important associated risk factors that negatively affect the psychological well-being of pregnant women with threatened miscarriage. It was determined that the pregnant women with threatened miscarriage had higher levels of stress, anxiety, intolerance to uncertainty, and their psychological well-being was much lower than the pregnant women without threatened miscarriage. It was determined that there was a moderate and negative relationship between the mean psychological well-being of pregnant women and the mean scores of intolerance to uncertainty.What are the implications of these findings for clinical practice and/or further research? This is the first case-control study to examine the determination of stress, anxiety, intolerance to uncertainty and psychological well-being of pregnant women with and without threatened miscarriage. Health professionals should evaluate the anxiety, stress, intolerance of uncertainty levels and psychological well-being of pregnant women, especially in the routine follow-up of risky pregnant women, and should provide holistic care not only physiologically but also bio-psychosocially to these pregnant women with a holistic approach.

Network pharmacological analysis and molecular docking of Huangqin-Baizhu herb pair in the treatment of threatened abortion.

BACKGROUND: The incidence of threatened abortion (TA) is increasing due to poor diet and living habits, which brings great pressure to pregnant women and their families. Huangqin-Baizhu herb pair recorded in ancient books of traditional Chinese medicine has been widely used in the treatment of TA with remarkable effect. In this study, we will use the network pharmacology method to predict the target and mechanism of Huangqin-Baizhu herb pair. METHODS: Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform database was used to screen the active components of Huangqin-Baizhu herb pair. Pubchem and Swiss Target Prediction databases were used to predict the action targets. Genecards, OMIM, and Drugbank databases were used to predict the related targets of TA. The intersection of drug target and disease target was selected and the intersection genes were uploaded to STRING database to construct protein-protein interaction network and conduct module analysis. Metascape database was used for Gene Ontology and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis, which was imported into Cytoscape software to construct component-pathway-gene network and finally verified by molecular docking. Ethical approval and informed consent of patients are not required because the data used in this study is publicly available and does not involve individual patient data or privacy. RESULTS: The main active components of the herb pair are baicalein, flavanone, and norwogonin, etc. The main targets are AKT1, VEGFA, STAT3, MAPK1, SRC, etc. Cluster module analysis shows that the targets are related to cell metabolism, immune regulation and hormone level regulation. There were 2073, 3169, and 161 KEGG pathways involved in the biological processes, cell components, and molecular functions of Gene Ontology analysis, respectively. The main KEGG pathways involved in the intervention were HIF1 signaling pathway, PI3K-Akt signaling pathway, and Rap1 signaling pathway. Molecular docking showed that the main active components of the herb pair were well combined with the key targets. CONCLUSIONS: In this study, 42 active components, 152 potential targets and 11 key targets of Huangqin-Baizhu herb pair for the treatment of TA were revealed, participating in multiple signaling pathways such as PI3K-Akt, providing a theoretical basis for further experimental research.

Effects of Dydrogesterone Tablets Combined with Zishen Yutai Pills on Threatened Abortion in Early Pregnancy and Pregnancy Outcomes.

Objective: To explore the effect of dydrogesterone tablets combined with Zishen Yutai pills on threatened abortion in early pregnancy and pregnancy outcomes. Methods: This study retrospectively analyzed the clinical data of 100 patients with threatened abortion in early pregnancy who came to the Linhai Second People's Hospital/Taizhou Municipal Hospital from January 13, 2021, to January 13, 2022. According to different treatment methods, 48 patients treated with progesterone injection were assigned to the control group (CG), while 52 cases with the combined therapy of dydrogesterone tablets and Zishen Yutai pills were assigned to the observation group (OG). The two groups were compared in terms of the following parameters: treatment efficacy, whole blood high shear viscosity, hematocrit (HCT), plasma fibrinogen (FIB) level, spiral artery pulsatility index (PI), uterine spiral artery blood flow resistance index (RI), lumbar and abdominal pain relief time, hemostasis time, estrogen levels, pregnancy outcomes, neonatal adverse outcomes, and incidence of adverse reactions. Results: Compared with CG, the therapeutic effect in OG was observed to be evidently better, and its pain relief time and hemostasis time in the waist and abdomen were markedly shorter. After treatment, the whole blood high shear viscosity, FIB, RI, PI, and estrogen levels of both groups improved statistically compared with those before treatment, with more significant improvements in OG compared with CG. OG was also superior to CG with markedly lower incidence of preterm birth, miscarriage, neonatal adverse outcomes, and adverse reactions and a drastically higher full-term pregnancy rate. Conclusion: Zishen Yutai pill combined with dydrogesterone tablets is of remarkable therapeutic effect in treatment of early threatened abortion, which can significantly improve clinical symptoms and pregnancy outcomes of patients, with a high safety profile, which is worthy of clinical application.

Chemical profile and miscarriage prevention evaluation of Jiao-Ai Decoction, a classical traditional Chinese formula.

Jiao-Ai Decoction (JAD), a classical traditional Chinese formula composed of seven Chinese herbs, has been widely used in clinical practice for the treatment of abortion for a long time. However, the material basis and pharmacological mechanism remain unclear. An integrative method combining ultra-performance liquid chromatography coupled with mass spectrometry (UPLC-MS/MS) analysis and therapeutic effect evaluation based on the hypothalamus-pituitary-ovarian axis (HPOA) was employed to elaborate these problems. Firstly, the chemical profile of JAD was identified by UPLC-Q-TOF-MS. Secondly, the main target ingredients from JAD were determined by UPLC-T-Q-MS. Finally, the miscarriage prevention of JAD on threatened abortion pregnant rats induced by mifepristone was investigated. Threatened abortion model in rats were replicated, uterine bleeding quantity (UBQ) and histopathological sections were measured, the contents of luteinizing hormone (LH), follicular stimulating hormone (FSH), estradiol (E2) and progesterone (P) were determined by ELISA, related genes and protein expression levels were detected by RT-PCR and western blotting. As a result, a total of 101 compounds were identified and 27 ingredients were determined to evaluate the quality of JAD. In the model rats, JAD could effectively regulate the HPOA to achieve miscarriage prevention, and the mechanism might be related to the regulation of gene and protein expression on the HPOA. This work could provide a novel and valuable approach for the quality evaluation of JAD and were expected to provide ideas and methods for the basic research on the scientific application of similar traditional Chinese medicine prescriptions.

Efficacy and safety of Yunkang oral liquid combined with conventional therapy for threatened miscarriage of first-trimester pregnancy a protocol for systematic review and meta-analysis.

INTRODUCTION: Threatened miscarriages is a common complication of first-trimester pregnancy. Due to the beneficial effects, there are increasing clinical studies on Yunkang oral liquid(YKOL). However, the efficacy and safety of YKOL are still unknown. The aim of this systematic review was to assess the efficacy and safety of YKOL in the treatment of threatened miscarriage during the first-trimester pregnancy (TMFP). METHODS: This protocol will be prepared according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. The systematic review will include all randomized controlled trials (RCTs) studies published until April 2021. Electronic sources including CNKI, WF, VIP, CBM, MEDLINE(PubMed), Embase, Cochrane Library, and Web of Science will be searched for potentially eligible studies. The international clinical trial registration platform and the Chinese clinical trial registration platform of controlled trials will be searched from their inception until April 1st, 2021. According to the inclusion and exclusion criteria, screening literature, extraction data will be conducted by two researchers independently. Statistical analysis will use RevMan 5.3.5 software. The strength of evidence from the studies will be evaluated with the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) methods. RESULTS: This study will provide evidence for YKOL combined with conventional therapy for TMFP. CONCLUSION: The efficacy and safety of YKOL combined with conventional therapy for TMFP will be assessed. SYSTEMATIC REVIEW REGISTRATION: INPLASY202140105 (https://www.doi.org/10.37766/inplasy2021.4.0105).

Research on the medication rules of Chinese herbal formulas on treatment of threatened abortion.

BACKGROUNDS: Threatened abortion (TA) is the most common complication during early pregnancy affecting 20%-25% pregnancies. A variety of Chinese herbal medicines have shown good protective effects against TA. OBJECTIVE: To analyze the different prescriptions for TA and summarize the medication rules for such treatment. METHODS: Data mining methods including frequency analysis, cluster analysis, factor analysis and association rule learning were used in this study. RESULTS: In total, 171 herbs and 398 formulas were collected. The most frequently used herbs are Dipsaci Radix (Xuduan, accounts for 7.58%). The top three categories were deficiency-tonifying herbs (29.24%), wind-damp dispelling herbs (12.87%) and heat-clearing herbs (9.94%). Eleven factors and 8 clusters with clinical significance for prescription were formed by factor and cluster analyses. CONCLUSIONS: Tonification methods including spleen and kidney nourishment are the main principles for TA treatment and Shoutai Pill can be used as the basic formula for clinical addition or subtraction.

Efficacy and safety of traditional Chinese herbal medicine in the treatment of threatened abortion: A protocol for systematic review and meta-analysis.

BACKGROUND: Threatened abortion (TA) is the commonest complication that occurs in early pregnancy, especially in 8-12 gestational weeks when the secretion of estrogen and progesterone shifts from corpus luteum to placental. Conventional therapies are little evidence of their value. In China, traditional Chinese herbal medicine has been widely used for the treatment of TA for a long time. The lack of strong scientific evidences make this a priority area for research. We aim to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment of TA, provide medical staffs with more useful information, and provide patients with better advises. METHODS: We will search 8 databases and additional sources, including the Web of Science, PubMed, Cochrane Library, Embase, CBM, Wanfang, VIP, CNKI, and WHO ICTRP, ChiCTR, Clinical Trials, Grey Literature Database, for potentially eligible studies. Literature search, screening and retrieval are performed independently by two researchers. In the event of a dispute, a third party will be consulted to support the judgment. We will use RevmanV.5.3 to perform a fixed-effect meta-analysis for clinical homogeneity study data, and the level of evidence will be assessed using the GRADE method. RESULTS: This systematic review and meta-analysis will put a high-quality synthesis of the efficacy and safety of traditional Chinese herbal medicine in the treatment of TA. CONCLUSION: The conclusion of this systematic review will provide evidence to assess traditional Chinese herbal medicine therapy whether is an efficacy and safe intervention to treat TA. ETHICS AND DISSEMINATION: Since this article does not contain patient personal information, ethical approval is not required. The contract is distributed by a peer-reviewed journal or conference report. REGISTRATION NUMBER: 10.17605/OSF.IO/DG3T8.

Systems Pharmacology-Based Research on the Mechanism of Tusizi-Sangjisheng Herb Pair in the Treatment of Threatened Abortion.

Threatened abortion (TA) is a common complication with high incidence in the first trimester of pregnancy, which will end in miscarriage if not treated properly. The Chinese herbs Cuscutae Semen (Tusizi in Chinese) and Herba Taxilli (Sangjisheng in Chinese) first recorded in the ancient classic medical book Shennong Bencao Jing are effective and widely used as an herb pair for the treatment of TA, while the active ingredients and the functional mechanism of Tusizi-Sangjisheng herb pair treating TA are still unknown. In order to exploit the relationship between those two herbs and TA, systems pharmacology analysis was carried out in this study. A total of 75 ingredients of Tusizi-Sangjisheng were collected from Traditional Chinese Medicine System Pharmacology Database and Analysis Platform (TCMSP). 12 bioactive compounds were screened, and 153 directly related targets were predicted by systematic models. Besides, Gene Ontology (GO) enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were used to systematically explore the potential mechanisms of Tusizi-Sangjisheng treating TA. Meanwhile, Compound-Target (C-T), Target-Disease (T-D), and Target-Pathway (T-P) networks were constructed to further quest the underlying functional mechanisms of Tusizi-Sangjisheng. As a result, 31 targets and 3 key pathways were found to be directly related to TA that includes mitogen-activated protein kinases (MAPKs), phosphatidylinositol-3-kinase/protein kinase B (PI3K-Akt), and transforming growth factor-ß (TGF-ß) signaling pathways. The results in this study may provide some valuable clues about the molecular mechanisms of the efficient Chinese herb pair Tusizi-Sangjisheng in the treatment of TA.

[Effect on immune factors and serum CA125 in patients of threatened abortion in early pregnancy complicated with subchorionic hematoma treated with auricular acupuncture combined with dydrogesterone].

OBJECTIVE: To evaluate the therapeutic effect of auricular acupuncture combined with dydrogesterone for threatened abortion in early pregnancy complicated with subchorionic hematoma. METHODS: A total of 80 patients were randomized into an observation group and a control group, 40 cases in each one. In the control group, dydrogesterone was taken orally twice a day, 10 mg a time until 12-week into pregnancy. In the observation group，auricular acupuncture was applied at penqiang (TF5), pizhixia (AT4), shen (CO10), xin(CO15), gan (CO12), jiaogan (AH6a) and neifenmi (CO18) on the basis of the control group, the auricular points on both sides were used alternatively. The auricular points were replaced every 3 days with 1 day break, totally 3 weeks (20 days) were required. Before treatment and after 10, 20 days of treatment, the percentage of helper T lymphocyte (Th) and inhibitory T lymphocyte (Ts), ratio of Th and Ts and serum level of CA125 were compared in the two groups. The areas of subchorionic hematoma and gestational sac were evaluated by B ultrasound. The therapeutic effect in the two groups were compared. RESULTS: The effective rate in the observation group was 80.0% (32/40), which was superior to 65.0% (26/40) in the control group (P<0.05). After 10, 20 days of treatment, the percentage of Th and ratio of Th and Ts were lower than before treatment, the percentage of Ts were increased in the two groups (P<0.01). After 20 days of treatment, the percentage of Th and ratio of Th and Ts in the observation group were lower than the control group (P<0.01), the percentage of Ts was higher than the control group (P<0.01). After 10, 20 days of treatment, the serum levels of CA125 were reduced compared before treatment in the two groups (P<0.01), and the serum levels of CA125 in the observation group were lower than the control group (P<0.01). After 10, 20 days of treatment, the ratio of subchorionic hematoma area and gestational sac area in the observation group was lower than the control group (P<0.01). CONCLUSION: Auricular acupuncture combined with dextroprogesterone can improve the effective rate of patients with threatened abortion in early pregnancy complicated with subchorionic hematoma, regulate immune factors, promote the hematoma absorption, and has a better synergistic effect with dextroprogesterone.

[Adjuvant therapy of acupoint catgut embedding for threatened abortion after in vitro fertilization-embryo transfer: a randomized controlled trial].

OBJECTIVE: To observe the effects of acupoint catgut embedding on miscarriage prevention and pregnancy outcome in patients with threatened abortion after in vitro fertilization-embryo transfer (IVF-ET). METHODS: Sixty cases of patients with threatened abortion after IVF-ET were randomly divided into an observation group and a control group, 30 cases in each group. The patients in the control group were treated with intramuscular injection of progesterone (40 mg) once every day, while the patients in the observation group, on the basis of the treatment of control group, were treated with catgut embedding at Geshu (BL 17), Ganshu (BL 18), Shenshu (BL 23), Pishu (BL 20), Weishu (BL 21), Xuehai (SP 10), Diji (SP 8) and Fuliu (KI 7), once every two weeks, six times as a course of treatment. The treatment was given until 12 weeks into pregnancy. The level of serum human chorionic gonadotropin (HCG), estradiol (E2) and progesterone (P) before and after treatment was recorded; the TCM syndrome score before and after treatment was compared; the successful pregnancy rate and spontaneous abortion rate after treatment were observed in the two groups. RESULTS: Compared before treatment, the scores of TCM syndrome in both groups were reduced after treatment (both P<0.01), and score in the observation group was superior to that in the control group (P<0.05). After treatment, the clinical efficacy in the observation group was superior to that in the control group (P<0.05). After treatment, the hormone levels (ß-HCG, E2, P) in both groups were increased steadily; the hormone levels in 6-week pregnancy, 8-week pregnancy and 10-week pregnancy were significantly higher than those in 4-week pregnancy (all P<0.05); except the levels of P and ß-HCG in 10-week pregnancy, the hormone levels in the observation group were superior to those in the control group (all P<0.05). After treatment, the early abortion rate was 16.7% (5/30) in the observation group, which was lower than 33.3% (10/30) in the control group (P<0.01); the pregnancy rate was 96.0% (24/25) in the observation group, which was higher than 80.0% (16/20) in the control group (P<0.01). CONCLUSION: Acupoint catgut embedding is effective for preventing threatened abortion, which could significantly reduce the spontaneous abortion rate, improve the pregnancy success rate, regulate hormone levels in patients after IVF-ET.

[The prevent miscarriage effects of Yun Kang oral liquid on threatened abortion rat induced by kidney deficiency and luteum inhibition].

OBJECTIVE: Yun Kang oral liquid is a listed proprietary Chinese Medicine. To further evaluate its efficacy, this experiment established a kidney deficiency and luteum inhibition threatened abortion rat model to observe the effects of Yun Kang oral liquid. METHODS: Sixty pregnant rats were randomly divided into normal control group (NC), model group (MG), dydrogesterone group (DT, 3.02 mg/kg), and Yun Kang oral liquid low-dose group (YK-L, 4 ml/kg), medium dose group (YK-M, 6 ml/kg), high dose group (YK-H, 9 ml/kg), 10 in each group. On the first day of pregnancy, each administration group was treated with the test drug at the prescribed dose every morning, and the NC group and the MG group were given an equal volume of purified water for 10 days; the rats were intragastrically administrated every afternoon, except for the NC group. In addition, the other groups were intragastrically administered with hydroxyurea at a dose of 450 mg/kg for 9 days, and mifepristone was administered at a dose of 4.0 mg/kg on the 10th day. On the 9th day of pregnancy, behavioral signs such as back temperature, grasping force, pain threshold, and autonomic activity were measured in each group. On the 11th day of pregnancy, blood was collected from the abdominal aorta in each group to determine serum levels of estradiol (E2) , progesterone (P) and thromboxane B2 (TXB2) . Ovary and fetal uterus were removed, the number and diameter of embryos were observed, and the ovary and uterus indexes were calculated. RESULTS: Compared with the NC group, the back temperature, grip, pain threshold, number of spontaneous activities, number of embryos, embryo diameter, uterus index and serum E2, P, TXB2 levels in the MG group were decreased significantly (P＜0.05, 0.01). Compared with the MG group, the back temperature, grasping force, number of embryos, embryo diameter and serum E2 and P levels were increased significantly in each dose group (P＜0.05, 0.01); the pain threshold, autonomic activity, and uterus index of YK-M and YK-H group were increased significantly (P＜0.05); serum level of TXB2 in YK-H group were increased significantly (P＜0.05). CONCLUSION: Yun Kang oral liquid has a clear kidney-filling effect on rats with threatened abortion caused by kidney deficiency-luteal suppression. The mechanism may be related to raising serum E2, P, TXB2 levels, improving kidney deficiency and improving embryo quality.

Adjuvant therapy of acupoint catgut embedding for threatened abortion after in vitro fertilization-embryo transfer: a randomized controlled trial / 中国针灸

OBJECTIVE@#To observe the effects of acupoint catgut embedding on miscarriage prevention and pregnancy outcome in patients with threatened abortion after in vitro fertilization-embryo transfer (IVF-ET).@*METHODS@#Sixty cases of patients with threatened abortion after IVF-ET were randomly divided into an observation group and a control group, 30 cases in each group. The patients in the control group were treated with intramuscular injection of progesterone (40 mg) once every day, while the patients in the observation group, on the basis of the treatment of control group, were treated with catgut embedding at Geshu (BL 17), Ganshu (BL 18), Shenshu (BL 23), Pishu (BL 20), Weishu (BL 21), Xuehai (SP 10), Diji (SP 8) and Fuliu (KI 7), once every two weeks, six times as a course of treatment. The treatment was given until 12 weeks into pregnancy. The level of serum human chorionic gonadotropin (HCG), estradiol (E) and progesterone (P) before and after treatment was recorded; the TCM syndrome score before and after treatment was compared; the successful pregnancy rate and spontaneous abortion rate after treatment were observed in the two groups.@*RESULTS@#Compared before treatment, the scores of TCM syndrome in both groups were reduced after treatment (both <0.01), and score in the observation group was superior to that in the control group (<0.05). After treatment, the clinical efficacy in the observation group was superior to that in the control group (<0.05). After treatment, the hormone levels (β-HCG, E, P) in both groups were increased steadily; the hormone levels in 6-week pregnancy, 8-week pregnancy and 10-week pregnancy were significantly higher than those in 4-week pregnancy (all <0.05); except the levels of P and β-HCG in 10-week pregnancy, the hormone levels in the observation group were superior to those in the control group (all <0.05). After treatment, the early abortion rate was 16.7% (5/30) in the observation group, which was lower than 33.3% (10/30) in the control group (<0.01); the pregnancy rate was 96.0% (24/25) in the observation group, which was higher than 80.0% (16/20) in the control group (<0.01).@*CONCLUSION@#Acupoint catgut embedding is effective for preventing threatened abortion, which could significantly reduce the spontaneous abortion rate, improve the pregnancy success rate, regulate hormone levels in patients after IVF-ET.

Effect on immune factors and serum CA125 in patients of threatened abortion in early pregnancy complicated with subchorionic hematoma treated with auricular acupuncture combined with dydrogesterone / 中国针灸

OBJECTIVE@#To evaluate the therapeutic effect of auricular acupuncture combined with dydrogesterone for threatened abortion in early pregnancy complicated with subchorionic hematoma.@*METHODS@#A total of 80 patients were randomized into an observation group and a control group, 40 cases in each one. In the control group, dydrogesterone was taken orally twice a day, 10 mg a time until 12-week into pregnancy. In the observation group，auricular acupuncture was applied at penqiang (TF), pizhixia (AT), shen (CO), xin(CO), gan (CO), jiaogan (AH) and neifenmi (CO) on the basis of the control group, the auricular points on both sides were used alternatively. The auricular points were replaced every 3 days with 1 day break, totally 3 weeks (20 days) were required. Before treatment and after 10, 20 days of treatment, the percentage of helper T lymphocyte (Th) and inhibitory T lymphocyte (Ts), ratio of Th and Ts and serum level of CA125 were compared in the two groups. The areas of subchorionic hematoma and gestational sac were evaluated by B ultrasound. The therapeutic effect in the two groups were compared.@*RESULTS@#The effective rate in the observation group was 80.0% (32/40), which was superior to 65.0% (26/40) in the control group (<0.05). After 10, 20 days of treatment, the percentage of Th and ratio of Th and Ts were lower than before treatment, the percentage of Ts were increased in the two groups (<0.01). After 20 days of treatment, the percentage of Th and ratio of Th and Ts in the observation group were lower than the control group (<0.01), the percentage of Ts was higher than the control group (<0.01). After 10, 20 days of treatment, the serum levels of CA125 were reduced compared before treatment in the two groups (<0.01), and the serum levels of CA125 in the observation group were lower than the control group (<0.01). After 10, 20 days of treatment, the ratio of subchorionic hematoma area and gestational sac area in the observation group was lower than the control group (<0.01).@*CONCLUSION@#Auricular acupuncture combined with dextroprogesterone can improve the effective rate of patients with threatened abortion in early pregnancy complicated with subchorionic hematoma, regulate immune factors, promote the hematoma absorption, and has a better synergistic effect with dextroprogesterone.

The prevent miscarriage effects of Yun Kang oral liquid on threatened abortion rat induced by kidney deficiency and luteum inhibition / 中国应用生理学杂志

OBJECTIVE@#Yun Kang oral liquid is a listed proprietary Chinese Medicine. To further evaluate its efficacy, this experiment established a kidney deficiency and luteum inhibition threatened abortion rat model to observe the effects of Yun Kang oral liquid.@*METHODS@#Sixty pregnant rats were randomly divided into normal control group (NC), model group (MG), dydrogesterone group (DT, 3.02 mg/kg), and Yun Kang oral liquid low-dose group (YK-L, 4 ml/kg), medium dose group (YK-M, 6 ml/kg), high dose group (YK-H, 9 ml/kg), 10 in each group. On the first day of pregnancy, each administration group was treated with the test drug at the prescribed dose every morning, and the NC group and the MG group were given an equal volume of purified water for 10 days; the rats were intragastrically administrated every afternoon, except for the NC group. In addition, the other groups were intragastrically administered with hydroxyurea at a dose of 450 mg/kg for 9 days, and mifepristone was administered at a dose of 4.0 mg/kg on the 10th day. On the 9th day of pregnancy, behavioral signs such as back temperature, grasping force, pain threshold, and autonomic activity were measured in each group. On the 11th day of pregnancy, blood was collected from the abdominal aorta in each group to determine serum levels of estradiol (E) , progesterone (P) and thromboxane B (TXB) . Ovary and fetal uterus were removed, the number and diameter of embryos were observed, and the ovary and uterus indexes were calculated.@*RESULTS@#Compared with the NC group, the back temperature, grip, pain threshold, number of spontaneous activities, number of embryos, embryo diameter, uterus index and serum E, P, TXB levels in the MG group were decreased significantly (P＜0.05, 0.01). Compared with the MG group, the back temperature, grasping force, number of embryos, embryo diameter and serum E and P levels were increased significantly in each dose group (P＜0.05, 0.01); the pain threshold, autonomic activity, and uterus index of YK-M and YK-H group were increased significantly (P＜0.05); serum level of TXB in YK-H group were increased significantly (P＜0.05).@*CONCLUSION@#Yun Kang oral liquid has a clear kidney-filling effect on rats with threatened abortion caused by kidney deficiency-luteal suppression. The mechanism may be related to raising serum E, P, TXB levels, improving kidney deficiency and improving embryo quality.