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Efficacy | SARS-CoV-2-specific T-cell memory | ASYMPTOMATIC COVID-19, EVENTS, SARS-COV-2 INFECTION | Evaluation of the ELISPOT assay test shows that 38.8% of subjects were reactive to SARS-CoV-2 S protein (significant increase of spot count) at day 14. This number increases where 62.2% of subjects were reactive to SARS-CoV-2 S protein at day 14 or day 28 (SARS-CoV-2-specific T-cell memory response.
In a 1-year observation of the subjects of the phase I clinical trial, eight people were confirmed positive for SARS-CoV-2 infection, all of whom were mild clinical symptoms and did not require hospital treatment (The number of mild symptomatic COVID-19 events from 3rd to 12thmonths in phase I subjects. No severe symptomatic COVID-19 events were observed.The number of mild and severe symptomatic COVID-19 events from 3rd to 12th months in phase II subjects. No significant difference between dose group (p>0.05). | PMC10315914 |
Discussion | PMC10315914 | |||
Safety | fatty liver, hypertension | FATTY LIVER, CNS INFECTIONS, RETINAL DETACHMENT, HYPERTENSION, TYPE 2 DIABETES MELLITUS, CORONARY ARTERY DISEASE | AEs that occur up to 28 days post-vaccination, based on reported data, are all mild. Non-COVID AE for up to 28 days was reported by 64.5% of phase I subjects and 53.6% of phase II subjects, and there were no significant differences between treatment groups (The short-term AE incidence rate of DC vaccines is lower compared to conventional COVID-19 vaccines (AE Non-COVID up to 1 year COVID-19 vaccine clinical trial.NA, Data not available.* Reported data are AE phase III clinical trials in the treatment group.The meaning of bold values are the result from our study. There was an incidence of type 2 diabetes mellitus, hypertension, coronary artery disease, fatty liver, retinal detachment, and other infections in phase II subjects ( | PMC10315914 |
Efficacy and antigen dosage | infection, SARS-CoV-2-specific memory T | ASYMPTOMATIC COVID-19, INFECTION, COVID-19 INFECTION | ELISPOT results show that this vaccine can induce SARS-CoV-2-specific memory T cells (Although phase II aims to determine the optimal dose of antigens, in this study, we also evaluated the efficacy of this vaccine in preventing the onset of moderately and severely symptomatic COVID-19 that requires hospital treatment. From a follow-up for 1 year, six subjects experienced moderate–severe symptomatic COVID-19 infection that required hospital treatment in phase II subjects. Thus, it was found that this vaccine protected 95.56% (intention-to-treat analysis, N = 138) of subjects from hospitalization due to COVID-19 for up to 1 year. When compared between dose groups, the proportion of subjects infected with COVID-19, both mild degrees undergoing self-isolation and severe degrees requiring hospital treatment, did not differ significantly. Therefore, there was no difference in efficacy between dose groups in preventing COVID-19 infection and preventing hospitalization. Based on its safety profile and immunogenicity for up to 28 days, the 0.1 mcg antigen dose group was designated as the optimal dose. In the evaluation for up to 1 year, there was no significant difference between the antigen dose groups in preventing the onset of moderately and severely symptomatic COVID-19, thus further supporting the selection of a dose of 0.1 mcg as the most optimal antigen dose formulation.Clinical trials of conventional COVID-19 vaccines mostly use humoral responses to assess vaccine immunogenicity, although correlates of protection from COVID-19 vaccines have not yet been established (Compared to the results of clinical trials of conventional vaccines, the proportion of COVID-19 AE incidence up to 1 year in this vaccine tends to be higher. However, this is likely because this study is a phase II clinical trial with a small number of subjects (AE COVID-19 up to 1 year COVID-19 vaccine clinical trial.The meaning of bold values are the result from our study. | PMC10315914 |
Feasibility | autoimmune and cancer | This research shows that personalized DC–based vaccines can be manufactured in pandemic situations. This clinical trial was conducted in two hospital centers with a production time of 1 week. Trained staff can produce vaccines in health facilities/hospitals with specific standard preparations. This vaccine is unsuitable for the mass vaccination program, which requires fast production time. However, due to its safety and ‘personal’ source, this vaccine is a promising option for subjects who cannot meet conventional vaccine criteria for medical reasons (e.g., in autoimmune and cancer patients) or non-medical (rejection religion/belief), and this needs to be continued with the phase III clinical trial with a larger number of subjects. Furthermore, this study used S-proteins that proved effective. This can cut the exploration time of antigen selection. However, it is necessary to consider using other antigens, for example, by adding variant antigens or designing proteins conserved in variants. This vaccine can be one of the COVID-19 vaccine options, thus expanding the range of COVID-19 vaccination. | PMC10315914 | |
Conclusion | SARS-CoV-2 infection | SARS-COV-2 INFECTION | Based on phase I and II clinical trials of DC–based COVID-19 prevention vaccines, the absence of SAE associated with vaccine administration for up to 1 year for SARS-CoV-2 infection shows good tolerability and safety. Of the three vaccine dose candidates tested, the smallest dose of 0.1 mcg provides good immunogenicity and is supported by minimal AE. A 1-year evaluation shows that this vaccine appears to have long-term immunogenic potential. The phase III trial with a larger number of subjects is needed to ensure the efficacy of this vaccine and see other possible side effects. | PMC10315914 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10315914 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Gatot Soebroto Army Hospital. The patients/participants provided their written informed consent to participate in this study. | PMC10315914 | ||
Author contributions | RS, JJ | TP, YN, EL, RT, M, RS, and NS contributed to the design, implementation, and analysis of the phase I trial. JJ, TP, MY, ES, RI, and BR contributed to the design, implementation, and analysis of the phase II trial. JJ, ES, RI, ES, and YN wrote the manuscript. All authors contributed to the article and approved the submitted version. | PMC10315914 | |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10315914 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10315914 | ||
References | PMC10315914 | |||
Background | NSCLC, tumor, death | TUMOR, METASTATIC NON-SMALL CELL LUNG CANCER, NSCLC | In CheckMate 227 Part 1 (NCT02477826), first-line nivolumab plus ipilimumab demonstrated long-term durable overall survival (OS) benefit versus chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. We report results in Japanese patients with ≥ 5-year follow-up. | PMC10542710 |
Methods | NSCLC | NSCLC | Adults with stage IV/recurrent NSCLC without | PMC10542710 |
Results | At 62.1 months’ minimum follow-up, 143 Japanese patients with PD-L1 ≥ 1% or < 1% were randomized to nivolumab plus ipilimumab ( | PMC10542710 | ||
Conclusions | NSCLC, tumor | TUMOR, NSCLC | At 5-year follow-up, nivolumab plus ipilimumab continued to show long-term durable clinical benefit versus chemotherapy, regardless of tumor PD-L1 expression. Consistent with findings for the global population, these data support the use of nivolumab plus ipilimumab as first-line treatment in Japanese patients with metastatic NSCLC. | PMC10542710 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s10147-023-02390-2. | PMC10542710 | ||
Keywords | PMC10542710 | |||
Introduction | NSCLC, death, tumor | TUMOR, METASTATIC NON-SMALL CELL LUNG CANCER, NSCLC | Programmed death 1 (PD-1) and programmed death ligand 1 (PD-L1) inhibitor-based immunotherapy in the first-line setting has significantly improved survival outcomes versus chemotherapy alone for patients with metastatic non-small cell lung cancer (NSCLC) [Immune checkpoint inhibitors, nivolumab, a fully human PD-1 antibody, and ipilimumab, a fully human cytotoxic T-lymphocyte antigen 4 antibody, have distinct but complementary mechanisms of action [Differences in treatment outcomes between Asian and non-Asian patients with NSCLC have been reported [It is therefore important to assess clinical outcomes in Japanese patients to better inform physicians of treatment options. Survival benefit with nivolumab plus ipilimumab across several tumor types has been reported in Asian populations, including Japanese patients [ | PMC10542710 |
Patients and methods | PMC10542710 | |||
Patients and treatment | toxicity, tumor | DISEASE PROGRESSION, TUMOR | Eligibility criteria for CheckMate 227 (NCT02477826) were described previously [Patients with tumor PD-L1 expression ≥ 1% were randomized 1:1:1 to receive nivolumab (3 mg/kg every 2 weeks [Q2W]) plus ipilimumab (1 mg/kg every 6 weeks), nivolumab monotherapy (240 mg Q2W), or platinum-doublet chemotherapy (every 3 weeks [Q3W] for ≤ 4 cycles). Patients with tumor PD-L1 expression < 1% were randomized 1:1:1 to receive nivolumab plus ipilimumab, nivolumab (360 mg Q3W) plus platinum-doublet chemotherapy (Q3W for ≤ 4 cycles), or platinum-doublet chemotherapy (Q3W for ≤ 4 cycles). Treatment continued until disease progression, unacceptable toxicity, or for ≤ 2 years for immunotherapy. | PMC10542710 |
Endpoints and assessments | tumor, immune-mediated adverse, death, Cancer | ADVERSE EVENT, TUMOR, ADVERSE EVENTS, SECONDARY, CANCER | The independent co-primary endpoint of OS in patients with tumor PD-L1 expression ≥ 1% and secondary endpoints were previously reported [Safety and tolerability, including treatment-related adverse events (TRAEs) and immune-mediated adverse events (IMAEs) were assessed in all treated Japanese patients. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Additional details on AEs are included in the supplementary methods (online only).Post hoc analyses in Japanese patients included efficacy outcomes (PFS, ORR, and DOR) evaluated in the combined PD-L1 ≥ 1% and < 1% population of patients alive at 5 years, efficacy outcomes (OS, PFS, ORR, and DOR) in the combined PD-L1 ≥ 1% and < 1% population of patients who discontinued study treatment due to TRAEs, and treatment-free interval (TFI; the time from last study dose to start of subsequent systemic therapy or death, whichever occurred first) measured in patients who discontinued study therapy (for any reason), in 5-year survivors, and in patients who discontinued study treatment due to TRAEs. | PMC10542710 |
Statistical analyses | tumor | TUMOR | Efficacy and safety analyses of nivolumab plus ipilimumab versus chemotherapy in the randomized and treated populations, respectively, of Japanese patients were exploratory and summarized using descriptive statistics. Time-to-event analyses for OS, PFS, DOR, and TFI were performed using the Kaplan–Meier method. Hazard ratios (HRs) with associated two-sided confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, with tumor histology as the strata and treatment group as a single covariate. An unstratified model was used to estimate HRs between treatment arms in patient subgroups. The Clopper-Pearson method was used to calculate 95% exact two-sided CIs for ORRs. | PMC10542710 |
Results | PMC10542710 | |||
Efficacy outcomes | PMC10542710 | |||
Patients alive at 5 years | In the combined PD-L1 ≥ 1% and < 1% population, 47 Japanese patients were alive at 5 years (nivolumab plus ipilimumab: PFS in Japanese patients alive at 5 years (PD-L1 ≥ 1% and < 1%). At the 5-year cut-off, 59% (95% CI, 39%–75%) of patients in the nivolumab plus ipilimumab arm versus 15% (95% CI, 4%–34%) in the chemotherapy arm were off treatment without receiving any subsequent therapy (Table | PMC10542710 | ||
Discussion | NSCLC, tumor, cancers, melanoma, TRAEs | TUMOR, CANCERS, MELANOMA, EVENT, DISEASE, NSCLC | The results of this subanalysis in Japanese patients from the CheckMate 227 Part 1 study represent the longest survival follow-up reported to date for phase 3 studies evaluating first-line combination immunotherapy for metastatic NSCLC with tumor PD-L1 ≥ 1% or < 1%. With a 5-year minimum follow-up, clinically meaningful OS benefit was maintained with nivolumab plus ipilimumab versus chemotherapy in Japanese patients regardless of tumor PD-L1 expression, despite a high rate of subsequent immunotherapy received in the chemotherapy arm (81%) in the combined PD-L1 ≥ 1% and < 1% population of patients with a PFS event. The results were consistent with the 3-year follow-up analysis in Japanese patients [PFS and DOR benefit was maintained with nivolumab plus ipilimumab at 5 years. Additionally, patients in the combined PD-L1 ≥ 1% and < 1% population who were alive at 5 years had a higher 3-year TFI rate with nivolumab plus ipilimumab versus chemotherapy, with 59% versus 15% of patients receiving no subsequent systemic therapy at the 5-year time point, suggesting the long-term durable benefit of this first-line immunotherapy combination in Japanese patients. Among patients who discontinued nivolumab plus ipilimumab treatment within 2 years due to TRAEs, 58% remained alive for ≥ 5 years, with 47% of patients receiving no subsequent therapy within 3 years of discontinuation.Recent studies in melanoma and other cancers have demonstrated that TFI, during which patients typically experience clinically stable disease while remaining treatment-free, is associated with improved quality of life [No new safety signals were reported in this subanalysis after long-term follow-up (≥ 5 years). TRAEs reported in Japanese patients at 5 years were consistent with the 3-year data [This exploratory subanalysis was not statistically powered to conduct statistical testing for comparisons between treatment arms. The subanalysis was also limited by small sample sizes for the patient subgroups. The findings in Japanese patients, however, were consistent with results in the randomized global population and aligned with findings from other immunotherapy-based treatments in this subpopulation [In conclusion, at ≥ 5-year follow-up, first-line nivolumab plus ipilimumab provided long-term efficacy benefits versus chemotherapy in Japanese patients with metastatic NSCLC, regardless of tumor PD-L1 expression. Consistent with the long-term findings in the randomized global population, these data continue to support the use of nivolumab plus ipilimumab as first-line treatment for patients with metastatic NSCLC in Japan. | PMC10542710 |
Acknowledgements | The authors thank the patients and their families, as well as the clinical study teams, for making this study possible; Faith E. Nathan, MD, who served as the clinical trial physician; and Suresh Alaparthy, who served as the global trial manager. This study was funded by Bristol Myers Squibb. The PD-L1 IHC 28-8 pharmDx assay was developed in collaboration with Dako, an Agilent Technologies company (Santa Clara, CA, USA). Medical writing support was provided by Vidya Rajagopalan, PhD, of Evidence Scientific Solutions, Inc., and was funded by Bristol Myers Squibb. | PMC10542710 | ||
Author contributions | HT | Patient treatment and data collection were performed by MN, YO, SI, TY, HH, TF, YS, HT, KH, SS, HD, IO, KK, TN and HM. Data analysis was performed by LL, RGG and JB. All authors contributed to the interpretation of results and preparation of the manuscript. All authors have read and approved the final manuscript. | PMC10542710 | |
Data availability | Data are available upon reasonable request. BMS policy on data sharing may be found at | PMC10542710 | ||
Declarations | PMC10542710 | |||
Conflicts of interest | EPS | ONCOLOGY | H.D. received honoraria from AstraZeneca and Chugai Pharmaceutical. H.H. received honoraria from Amgen K.K., AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., Kyorin Pharmaceutical Co. Ltd., Merck Biopharma Co. Ltd., MSD K.K., Novartis Pharmaceutical K.K., Ono Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd.; received consulting fees from AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Guardant Health, Merck Biopharma Co. Ltd., Pfizer Japan Inc., Shanghai Haihe Biopharma, and Takeda Pharmaceutical Co. Ltd.; and received research funding from A2 Healthcare Corp., AbbVie Inc., Astellas Pharma Inc., AstraZeneca K.K., Bayer Yakuhin Ltd., Bristol Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., CMIC Shift Zero K.K., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., Eisai Co. Ltd., EP-CRSU Co. Ltd., EPS Corp., EPS International Co. Ltd., Gritstone Oncology Inc., ICON Japan K.K., inVentiv Health Japan, Kissei Pharmaceutical Co. Ltd., Kyowa Hakko Kirin Co. Ltd., Linical Co. Ltd., Merck Serono Co. Ltd., Merck Biopharma Co. Ltd., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., Parexel International Corp., Pfizer Japan Inc., Pfizer R&D Japan G.K., Quintiles Inc./IQVIA Services Japan K.K., SymBio Pharmaceutical Ltd., Syneos Health, Taiho Pharmaceutical Co. Ltd., and Takeda Pharmaceutical Co. Ltd. K.H. received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, MSD, Nippon Kayaku, Pfizer, and Takeda; and received research funding from AbbVie, AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, and MSD. S.I. received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, and Takeda; and received research funding from AstraZeneca and Chugai Pharmaceutical. K.K. received honoraria from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, MSD, and Ono Pharmaceutical; and received research funding from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, MSD, and Ono Pharmaceutical. T.N. received honoraria from Ono Pharmaceutical and research grants from Ostuka Pharmaceutical. M.N. received honoraria from Bristol Myers Squibb and Ono Pharmaceutical. Y.O. received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Eli Lilly, Kyowa Hakko Kirin, MSD, Nippon Kayaku, Ono Pharmaceutical, Pfizer, and Taiho Pharmaceutical; and received research funding from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Dainippon Sumitomo, Janssen, Kissei, Kyorin, Lilly, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, and Takeda. I.O. received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, MSD Oncology, Ono Pharmaceutical, and Taiho Pharmaceutical; and received research funding from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Lilly, MSD Oncology, Ono Pharmaceutical, and Taiho Pharmaceutical. Y.S. received honoraria from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, MSD, Nippon Kayaku, Ono Pharmaceutical, Pfizer, and Taiho Pharmaceutical. S.S. received honoraria from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, MSD K.K., and Ono Pharmaceutical. H.T. received honoraria from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Pharma, Eli Lilly, MSD, Ono Pharmaceutical, Takeda, and Taiho Pharmaceutical; and received research funding from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Pharma, Eli Lilly, MSD, Ono Pharmaceutical, Takeda, and Taiho Pharmaceutical. T.Y. received honoraria from AstraZeneca K.K., Bristol Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Nippon Kayaku Co. Ltd., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., and Takeda Pharmaceutical Co. Ltd.; and received research funding from Bristol Myers Squibb Co. Ltd., Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co. Ltd., Delta-Fly Pharma, Janssen Pharmaceutical K.K., MSD, and Takeda Pharmaceutical Co. Ltd. J.B., R.G.G., and L.L. are employees of Bristol Myers Squibb and received stock ownership from Bristol Myers Squibb. T.F. and H.M. declare no competing interests. | PMC10542710 |
Ethical approval | The institutional review board or independent ethics committee at each center approved this trial and it was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. All patients provided written informed consent. The trial protocol has been published previously (Hellmann MD, et al. | PMC10542710 | ||
References | PMC10542710 | |||
Keywords | WARTS, PLANE WARTS | Immunotherapy represents a promising therapeutic option for treatment of warts. Different concentrations of Candida antigen (1/100 and 1/1000) and zinc sulfate 2% were not previously compared regarding their efficacy in treatment of cutaneous warts. The present study compared the safety and efficacy of intralesional candida antigen versus intralesional 2% zinc sulfate for treatment of cutaneous warts. This prospective controlled clinical trial included one hundred and five patients presented with common, plantar, and plane warts. Patients were divided randomly into three groups, each group included 35 patients. Group 1 were treated with intralesional candida antigen (Ag) 1/100, Group 2 were treated with intralesional candida Ag 1/1000, and Group 3 were treated with intralesional zinc sulfate 2%. This study found that target warts of group 1 displayed higher rate of complete clearance compared to group 2 and group 3 (94.3%, 77.1, 74.2%), respectively. The present study concluded that intralesional immunotherapy with Candida antigen was more effective than Intralesional 2% zinc sulfate in treatment of cutaneous warts and less painfulOpen access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10205831 | |
Introduction | wart | HYPERSENSITIVITY RESPONSE, WART, RECURRENCE, HPV INFECTION, WARTS, MUMPS, PLANE WARTS | Two therapeutic options are used for treatment of warts: the first is the destructive method, like chemical cautery, cryotherapy, electrocauterization, surgical excision, and laser ablation, which are painful and with common recurrence [Intralesional (IL) immunotherapy with different skin test antigens like Candida, mumps, or trichophyton antigen induce a delayed type of hypersensitivity response to various antigens and the wart tissue leading to production of Th1 cytokines which activate cytotoxic and natural killer cells to eradicate HPV infection. This clears not only the local warts but also distant warts [Zinc is important for immune regulation as it stimulates the leucocytes and natural killer cells, zinc was found to be deficient in patients with multiple or recurrent warts [Different concentrations of Candida antigen (1/100 and 1/1000) and zinc sulphate were not previously compared regarding their efficacy in treatment of warts. This study compared the efficacy and safety of intralesional (IL)injection of different concentrations of Candida Ag (1/100 and 1/1000) and zinc sulfate 2% in patients with multiple palmar, plantar, and plane warts. | PMC10205831 |
Study design | COMPLICATIONS | This randomized controlled prospective clinical study (simple randomization) was approved by the Institutional Ethics and Research Committee of Faculty of Medicine, Assiut University, Assiut, Egypt, with clinical trial registration number (Clinical Trials.gov Identifier: NCT03158168). A written informed consent was obtained from each patient or their guardians in case of children, after informing him/her about the technical and scientific basis of the research, the steps of the procedure, and the expected effects or possible complications. | PMC10205831 | |
Patients and methods | PLANE WARTS | A total of 105 randomly selected patients, presented with multiple palmar, plantar, and/or plane warts, were enrolled in the study from March 2018 to March 2020 and completed the study. They were recruited from the Outpatient Clinic of Dermatology Department, Assiut University Hospital. | PMC10205831 | |
Inclusion criteria | PLANTAR WARTS, WARTS, VIRAL WARTS | Patients with cutaneous (extragenital) viral warts (single or multiple, new, or recurrent, common, plane and plantar warts) of different sizes and durations and with or without distant warts (warts in different anatomical sites) were included. There is no concurrent systemic or topical treatment for warts. Age ranged from 4 to 50 years. | PMC10205831 | |
Statistical analysis | Data entry and data analysis were done using SPSS version 22 (Statistical Package for Social Science). Data were presented as number, percentage, mean, median, and standard deviation. Chi-square test was used to compare qualitative variables. Mann–Whitney test was used to compare quantitative variables between two groups and Kruskal–Wallis test for more than two groups. Spearman correlation was done to measure correlation between quantitative variables. | PMC10205831 | ||
Author contributions | The authors contributed equally in the study design and patient's treatment, writing and reviewing the main manuscript text, preparing figures,data collection and analysis. | PMC10205831 | ||
Funding | Open access funding are provided by The Science, Technology& Innovation Funding Authority (STDF) in cooperation with the Egyptian Knowledge Bank (EKB). | PMC10205831 | ||
Data availability statement | The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10205831 | ||
Declarations | PMC10205831 | |||
Competing interests | The authors have no conflict of interest to declare. | PMC10205831 | ||
Ethical approval | All procedures performed in this randomized controlled prospective clinical study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Institutional Ethics and Research Committee of Faculty of Medicine, Assiut University, Assiut, Egypt. Clinical trial registration number is (Clinical Trials.gov Identifier: NCT03158168). | PMC10205831 | ||
Informed consent | COMPLICATIONS | A written informed consent was obtained from each patient or their guardians in case of children, after informing him/her about the technical and scientific basis of the research, the steps of the procedure, and the expected effects or possible complications. | PMC10205831 | |
References | PMC10205831 | |||
1. Introduction | Coffeeberry extract, fatigue | Background: Coffeeberry extract, rich in chlorogenic acids, shows promise in improving mood and cognition, particularly when co-supplemented with phenolic compounds. However, limited work has considered the effects of coffeeberry in isolation, especially at low doses. Objective: The current study investigated the effect of low and moderate doses of coffeeberry extract on cognition and mood. Design: This randomized, double-blind, placebo-controlled crossover design investigated three active beverages on a sample of 72 healthy adults aged 18–49 years. The investigational beverages contained 100 mg or 300 mg coffeeberry extract (standardized to 40% chlorogenic acid), or 75 mg caffeine (positive control). Cognition, mood, and subjective energy were measured at baseline and then again at 60 and 120 min post-treatment. Results: Analysis revealed no effect of 300 mg coffeeberry extract, while 100 mg resulted in increased mental fatigue during the performance of cognitively demanding tasks (Considerable interest has been placed on the potential health-promoting effects of polyphenols, specifically with regards to their effects on cognition. [Coffeeberry extract (also referred to as coffee cherry), rich in chlorogenic acids (CGA) and low in naturally occurring caffeine, is a promising candidate. Previous work has indicated that coffeeberry extract can interact with biological systems underlying brain function. For example, acute supplementation of 100 mg whole coffee fruit extract has been shown to significantly increase concentrations of brain-derived neurotropic factor (BDNF) in plasma [To date, investigations of coffeeberry extract have explored effects following single doses of coffeeberry and also when co-supplemented with additional phenolic and herbal compounds. Taking the latter as an example, in healthy, young adults, acute improvements in mood were observed following 1100 mg coffeeberry extract (440 mg chlorogenic acid, 22 mg caffeine) in combination with beetroot (10 g), ginseng (170 mg), and sage (280 mg) extracts [Trials administering coffeeberry extract in isolation to cognitively intact adults are limited; however, similar mood enhancements have been observed following 1100 mg coffeeberry extract [ | PMC10254646 | |
2. Materials and Methods | PMC10254646 | |||
2.1. Study Design and Participants | BRAIN | The study followed a randomised, double-blind, placebo-controlled crossover design with four study arms. Research took place from July 2021 to January 2022 at the Brain, Performance and Nutrition Research Centre (BPNRC) at Northumbria University. The Northumbria University Health and Life Sciences Ethics Committee reviewed and approved all study procedures used (Reference 33646), with investigations following the rules of the Declaration of Helsinki 1975. The study was also pre-registered on A volunteer sample of 75 participants aged 18–49 years was recruited and consumed at least one dose of treatment. Three of these participants discontinued with the study following the first testing visit, with a further participant discontinuing following the second testing visit. Three of these participants were replaced, with one not replaced due to time constraints. The data from the unreplaced participant were still included within the final analysis, leaving a total sample of 72 participants. For a full summary of enrolment and flow of participants, see A power calculation based upon previous repeated measures data showing an effect size of f = 0.175 [ | PMC10254646 | |
2.2. Treatments | When attending each of the four testing visits, participants were given one of four beverages (labelled A, B, C, D) via random allocation according to a counterbalancing order (Latin square) that was generated by computer. Specifically, participants were block randomized to one of eight possible treatment orders (ABCD, ADCB, BADC, BDCA, CADB, CBAD, DABC, DCBA); participants who replaced a discontinued participant were allocated to the same treatment order as the participant they replaced. The bottles contained 10 oz and were identified only by their letter indicator.The beverages were matched for colour, aroma, and taste, with a cherry flavour being selected to mask any differences in taste that may have been apparent. The placebo beverage, sweetened with sucralose (0.03%), contained no active ingredients. The treatment beverages contained the placebo drink as a base, along with either 100 mg coffeeberry extract, 300 mg coffeeberry extract, or 75 mg caffeine acting as a positive control due to being an established psychostimulant. The coffeeberry extract was standardized to 40% chlorogenic acid (CognatiQ | PMC10254646 | ||
2.3. Cognitive and Mood Assessment | fatigue, alertness | The cognitive function tests were administered to participants using the Computerised Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK). COMPASS allows for bespoke task batteries to be designed as needed, with randomised parallel versions of the tasks being administered at each of the assessments for each participant.The cognitive assessment administered to participants was primarily comprised of four repetitions of the Cognitive Demand Battery (CDB), a ten-minute battery of three tasks plus two visual analogue scale (VAS) ratings of alertness and mental fatigue. The CDB consists of serial subtractions of both 3 s and 7 s, along with a sustained attention task (rapid visual information processing (RVIP)); full descriptors of these tasks can be found within the As previous research involving extracts containing chlorogenic acid has found them to modulate episodic memory [Mood and psychological state was assessed with Bond–Lader visual analogue scales [ | PMC10254646 | |
2.4. Procedure | HOLIDAY, COVID-19 INFECTION | Participants were required to attend six appointments: a remote screening appointment, a training appointment, and four test visits. The remote screening visit was conducted over the telephone, and it comprised a briefing on the requirements of the study, the signing of a virtual consent form, review of the inclusion and exclusion criteria included in the self-reported health screening, completion of the Caffeine Consumption Questionnaire (CCQ), and collection of relevant demographic information such as handedness. Following the initial remote screening, eligible participants were then required to attend a training visit, in which a physical informed consent form was signed. Physiological information that could not be collected remotely, namely, height, weight, waist-to-hip ratio (WHR), and blood pressure (BP), was collected, along with a measure of their usual sleep. Training on the cognitive tasks, EFS, and mood scales was also completed; the completion of cognitive training ensured that participants understood the instructions for both the tasks and the testing procedures and allowed individuals who were unable or unwilling to perform to a minimum standard to be excluded. The first testing visit was at least 48 h and no more than 27 days after the training visit, with each testing visit being 7 days apart (mean 8.55 days ± 5.01; range 5–45 days). Reasons for date deviations more than 14 days were related to COVID-19 infection and/or testing visits falling over the Christmas holiday period.On each of the four testing visits, participants attended the laboratory having followed the pre-visit instructions given at the training visit specifically (a) to consume the same meal no later than an hour before each visit; (b) to avoid caffeine in any form for 12 h prior to the visit; (c) to avoid moderate-to-vigorous physical activity for 24 h prior to the visit; (d) to have a usual night sleep prior to each visit (no more than ±1.5 h according to the self-reported amount at the training visit); and (e) to avoid alcohol for 24 h prior to the visit). Participants first completed the baseline testing battery (picture and word memory task presentation, 4 repetitions of CDB, followed by EFS and mood scales) before being given their assigned treatment beverage and consuming it fully within 10 min. A 60-minute absorption rest period followed, during which participants were instructed to refrain from mobile phone use but were allowed to watch TV or read. At 60 min post-treatment, participants completed the testing battery of four repetitions of CDB and EFS and mood scales again before being given another quiet rest period of 15 min. At 120 min post-treatment, participants completed the testing battery a final time (four repetitions of CDB and EFS and mood scales), along with completing the episodic memory tasks. All testing visits were identical aside from the randomly generated parallel versions of each of the memory tasks and lasted 4–4.5 h in length ( | PMC10254646 | |
2.5. Statistics | cognitive and mood, fatigue | All cognitive and mood outcome measures were modelled using the MIXED procedure in SPSS (version 26.0, IBM Corp., Armonk, NY, USA). For the episodic memory outcomes, the post dose data were modelled including treatment as a fixed effect. For the CDB task and VAS outcomes, changes from baseline values were modelled with treatment, minutes post dose (60, 120), repetition (1–4), and their interactions as fixed effects and participant as a random effect. For the psychological state and mood scales, changes from baseline data were modelled with treatment, minutes post dose (60, 120), and their interaction as fixed effects and participant as a random effect. Pairwise comparisons were all specified a priori and carried out using Sidak corrections. The a priori comparisons of 100 mg and 300 mg coffeeberry against placebo at 120 min post dose on the mental fatigue and alertness scales were specified as primary endpoints. | PMC10254646 | |
3. Results | Of the seventy-five participants who were randomized to receive treatment, three participants discontinued following testing visit 1, and one discontinued following testing visit 2. Of these four participants who discontinued, three were replaced and one could not be replaced due to time constraints of the study timeline. However, their data were included in the final analysis, leaving a final dataset comprising 72 participants. Approximately half ( | PMC10254646 | ||
3.1. Response to Coffeeberry | PMC10254646 | |||
3.1.1. Mood and Psychological State | (CDB).A, fatigue | For the primary endpoints, a priori pairwise comparisons of change from baseline data collected at 120 min post dose revealed no significant effect of treatment on either the mental fatigue or alertness scales (CDB).A priori pairwise comparisons of change from baseline data collected at 60 min post dose revealed the mental fatigue (CDB) was significantly increased following 100 mg coffeeberry, compared to placebo (No other mood or psychological state effects were observed, including mental fatigue on the EFS. | PMC10254646 | |
3.1.2. Cognitive Performance | A priori pairwise comparisons of change from baseline data, collected at 60 and 120 min post dose, revealed that 100 mg coffeeberry significantly decreased RVIP accuracy at 60 min post dose compared to placebo (No other significant comparisons were observed. See | PMC10254646 | ||
3.2. Response to Caffeine (Positive Control) | The analysis revealed that of the 25 outcome measures that were collected at each of the two post dose assessments, a significant main effect of treatment was observed for 24 of these. Pairwise comparisons revealed a consistent alerting and performance enhancing effect of the positive control beverage containing 75 mg caffeine in comparison to both the placebo beverage and the drinks containing coffeeberry, although there was some variation in where the significant comparisons were observed (see | PMC10254646 | ||
4. Discussion | fatigue | The results of the current study suggest that the consumption of 300 mg coffeeberry extract has no effect on mood, performance of cognitively demanding tasks, or episodic memory up to 120 min post dose. Limited results were observed following 100 mg coffeeberry, which followed a pattern of negative effects. Specifically, compared to placebo, participants who received 100 mg coffeeberry reported increased mental fatigue during performance of cognitively demanding tasks at 60 min post dose, although no effect was observed for mental fatigue on the EFS-State. In addition, decreased accuracy on the RVIP task was also observed following 100 mg coffeeberry at 60 min post dose compared to placebo. In contrast to this, a consistent pattern of alerting and performance enhancing effects was observed following 75 mg caffeine compared to placebo—and in some instances also compared to the two coffeeberry beverages—confirming that the study procedures were sensitive, despite the null or negative effects observed following the coffeeberry interventions.The findings of the present study differ from those reported in previous intervention trials investigating coffeeberry extract either co-supplemented with other phenolics or administered in isolation. Specifically, the negative results following 100 mg coffeeberry extract observed here are unexpected and difficult to explain; however, when considering the current literature, there is some disparity in findings at this dosage. Previously, 100 mg of the same coffeeberry extract that was evaluated in the current study co-administered with 275 mg apple extract had no effect on performance of the CDB (also with four repetitions per assessment) or measures of episodic memory and executive function assessed at 60-, 180- and 360-min post dose [The current study did not replicate the findings of Reed et al. [One consideration with regards to the negative findings is that it could be hypothesized in a dose–response model that any effects, positive or negative, would be exaggerated following three times the dose. However, this was not observed in the current study, with no effects observed following 300 mg coffeeberry. Therefore, given the small number and transient nature of these negative effects amongst many analyses, and the fact that this is the first report of any negative effects on cognitive performance or mood measures following interventions containing coffeeberry extract [Previously, data from our research centre has shown a consistent alerting/arousing effect of 1100 mg coffeeberry extract when administered in isolation [Besides dose, a final consideration is the timing of the assessments, which only extended until 120 min post dose in the current study. Bioavailability data suggest that a number of CGA only reach peak concentration in plasma after 4 and 6 h post dose [ | PMC10254646 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10254646 | ||
Author Contributions | P.A.J., D.O.K. and J.J. contributed to the design of the protocol; C.K. and B.S. collected the data; J.F. supervised data collection; P.A.J. analysed the data; P.A.J., E.F.S. and R.E. prepared the initial draft of the manuscript. All authors have read and agreed to the published version of the manuscript. | PMC10254646 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and the Northumbria University Health and Life Sciences Ethics Committee reviewed and approved all study procedures used (reference code 33646 on 24 June 2021). | PMC10254646 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10254646 | ||
Data Availability Statement | The data presented in this study are available upon request from the corresponding author. The data are not publicly available due to data sharing and privacy regulations in Europe and UK. | PMC10254646 | ||
Conflicts of Interest | J.J. is an employee of PepsiCo, the sponsor of the study. J.J. contributed to the design of the protocol and provided comments on the manuscript but had no role in collection, analysis, or interpretation of the results. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of PepsiCo, Inc. All other authors declare no conflict of interest. | PMC10254646 | ||
References | fatigue | Participant disposition flowchart.Timeline of the testing visit assessment schedule. CDB, Cognitive Demand Battery; EFS-State, mental and physical energy and fatigue scales.Estimated marginal means of change from baseline values (±SE) derived from the linear mixed model for the Cognitive Demand Battery (CDB) ‘Mental Fatigue’ Visual Analogue Scale (VAS). Pairwise comparisons revealed that when participants consumed 100 mg CB, they felt more mentally fatigued (Estimated marginal means of change from baseline values (±SE) derived from the linear mixed model for accuracy performance on the Rapid Visual Information Processing (RVIP) task. Pairwise comparisons revealed that when participants consumed 100 mg CB, RVIP accuracy was significantly reduced at 60 min post dose ( | PMC10254646 | |
Methods | Tele-midwifery | Seventy primiparous women attending the prenatal clinic of Baharlou Hospital in Tehran, Iran, were randomly assigned to two parallel intervention and control groups with 35 participants each. Women in the intervention group received Tele-midwifery for eight weeks, whereas women in the control group only received routine care. The Wijma delivery expectancy/experience questionnaire and the Childbirth Self-Efficacy Inventory were used to measure the FOC and self-efficacy at baseline and eight weeks after the intervention. The FOC and birth mode were also measured after birth. | PMC10619799 | |
Results | There was a significant decrease in FOC among women in the intervention group compared to control groups after eight weeks of intervention (- 20.9 [95% Confidence Interval,—24.01 to—17.83], p < 0.001), and after birth (- 30.8, [95% CI—33.8 to—27.97], p < 0.001). After eight weeks, the mean self-efficacy score in the intervention group was significantly higher than the control group (p < 0.001). Compared to the control group, the intervention group had a lower C-Section (CS) rate (p = 0.03). | PMC10619799 | ||
Conclusions | Tele-midwifery | Tele-midwifery intervention reduced FOC, increased women’s self-efficacy in childbirth, and decreased the number of CS in a group of first-time mothers. Healthcare providers can use the mHealth approach to support pregnant women with FOC. | PMC10619799 | |
Trial registration | Registration number: IRCT20200122046227N1, Registered on 27 January 2020. | PMC10619799 | ||
Data Availability | The authors confirm all the data collected in this study has been thoroughly presented within the paper. However, this study was conducted in a single center over a short period of time, so making the data set public may lead to participant identification. Data set will be available upon request from the ethics committee of Tehran University of Medical Sciences at | PMC10619799 | ||
Introduction | traumatic childbirth | COMPLICATIONS | Fear of childbirth (FOC) is a well-known problem affecting women, especially primiparous during pregnancy and postpartum period [Even though various interventions such as yoga, art therapy, and counseling, have been shown to be effective in reducing FOC, there is no consensus regarding the best treatment for alleviating women’s fears [Preventing FOC and promoting positive attitudes towards childbirth during pregnancy are critical factors in reducing the risk of traumatic childbirth and other complications associated with pregnancy and childbirth. Currently, there is no systematic approach for screening and treating women with FOC [ | PMC10619799 |
Materials and methods | PMC10619799 | |||
Study design and eligibility criteria | Tele-midwifery, fetus abnormalities | PLACENTAL ABRUPTION, CHRONIC DISEASES, PREECLAMPSIA | We conducted a Randomized Clinical Trial (RCT) to evaluate the effectiveness of using an mHealth application called Tele-midwifery to reduce FOC, increase childbirth self-efficacy, and reduce the number of CS among primiparous women. The research setting was the perinatal clinic of Baharlou Hospital in Tehran, Iran, and enrollment took place from February to April 2020.Inclusion criteria in this study were: being primiparous, having FOC (confirmed by the score of 38 and above on the Wijma delivery expectancy/experience questionnaire (W-DEQ)), being between 18 to 40 years of age, pregnant with a singleton fetus, 26–29 weeks of pregnancy, having access to a smart device such as a smartphone, or a tablet (women or their spouses), as well as the ability to work with them, having access to the Internet, not having chronic diseases and CS indications before or during pregnancy. The exclusion criteria were, emergency pregnancy conditions that required intervention (e.g., severe symptoms of COVID-19, placental abruption, fetus abnormalities, preeclampsia). | PMC10619799 |
Outcomes | SECONDARY | The primary outcome of this study was a change in FOC score. The secondary outcomes were a change in childbirth self-efficacy score, and childbirth mode. | PMC10619799 | |
Measures | In this study, the fear related to childbirth in the prenatal and postnatal period was measured using W-DEQ versions A and B. W-DEQ version A evaluates women’s prenatal expectances before childbirth, and W-DEQ version B evaluates experiences with recent childbirth. Each version contains 33 items with a 6-point Likert scale ranging from 0 (extremely) to 5 (not at all), and scores range from 0 to 165, with higher scores indicating higher fear of childbirth [The Childbirth Self-Efficacy Inventory (CBSEI) is a self-report instrument that measures outcome expectancies (OE) and efficacy expectancies (EE) for coping with an approaching childbirth experience. This questionnaire has two parts and 62 items that scored on a ten-point Likert scale (1 = not at all; 10 = completely sure), with a higher score indicating greater childbirth self-efficacy. The reliability of the questionnaire has been confirmed with Cronbach’s alpha 0.86–0.95 [ | PMC10619799 | ||
Sample size | The sample size was calculated based on our primary outcome which was FOC. We referred to the results of Gözde Birsbir et al.’s (2016) study on the effect of antenatal education on FOC to estimate our sample size [ | PMC10619799 | ||
Procedures | Tele-midwifery | RECRUITMENT | A convenience sampling approach was used, and a consecutive sample of pregnant women attending to the selected prenatal clinic for receiving their routine prenatal care were evaluated using their medical records for inclusion and exclusion criteria, by a colleague not involved in the study. Afterward, the objectives of the study were explained to eligible pregnant women. After consent was obtained, they were asked to complete the W-DEQ version A. women with a score of 38 and above (moderate and high FOC score) were enrolled in the study. A total of 214 pregnant women were evaluated for recruitment in the study. Specifically, 98 women did not meet the inclusion criteria, and 32 women declined to participate. Overall, 70 eligible individuals were randomly assigned to intervention (Tele-midwifery application) and control groups, with 35 participants in each ( | PMC10619799 |
CONSORT flow diagram of the study. | Tele-midwifery | A randomized allocation into two groups of intervention and control with a 1: 1 ratio took place during the routine prenatal visit in the hospital. A colleague who was not involved in the study put each computerized generated random sequences separately in sealed and opaque envelopes. To mask the person performing the allocation, the letters A and B were used to assign women to the intervention or control group. In both intervention and control groups, the Tele-midwifery application was installed on their smartphones during their prenatal visit, and instructions for using the application were explained. This application only allowed access to the questionnaires in the post-test, and follow-up stages for participants in the control group. However, the intervention group had access to all features of the application. The researcher could track the women’s activities in the application, and in case the women had not use the application for more than two days, a reminder was sent to follow them up. To prevent information contamination in the control group, after installing the application and before activating their account, women selected their group type as A or B. In addition, we asked the women in both groups to avoid sharing the contents of the application with each other for the duration of the trial. The Tele-midwifery application had two main stages for answering the questions. After filling out the baseline questionnaire in the initial registration, including demographic, W-DEQ, and CBSE questionnaires, each groups of participants completed the W-DEQ and CBSE questionnaires again at 34–36 weeks (after eight weeks of receiving the intervention). Participants were also asked to inform the researcher by sending a message after hospitalization for their birth, whether in the Tele-midwifery application or by contacting the researcher directly by her phone number. Afterward, the W-DEQ version B questionnaire appeared in the application within the first two hours after birth, and the birth mode was recorded. Due to the nature of the intervention, it was not possible to mask participants from the group allocation. However, investigators, care providers, data collectors, and statisticians were masked from the allocation. | PMC10619799 | |
Tele-midwifery application | Tele-midwifery | First, to prepare the Tele-midwifery application’s content, reliable and up-to-date scientific sources such as textbooks, scientific articles, related guidelines, studied carefully by the research team, and necessary content in various fields were reviewed [ | PMC10619799 | |
Dimensions of intervention | PMC10619799 | |||
Education | labor pain, Tele-midwifery | COMPLICATIONS | The educational content of the Tele-midwifery application was designed to include all possible causes of FOC in Iranian women, such as fear of labor pain, lack of information related to the mother and baby’s health, what women should expect during labor and birth, the characteristics of each stage of labor, misconceptions such as distrust of healthcare providers, and complications of vaginal birth [ | PMC10619799 |
Five components of educational content of Tele-midwifery application. | PMC10619799 | |||
Continuous support and engagement of women | To provide continuity of care and support between two prenatal visits, participants in the intervention group, could contact the researchers if they had concerns and questions about their pregnancy and birth care. The team of researchers including midwives and obstetricians were available throughout the day (between 7 a.m. to 9 p.m.), to provide women with an accessible source of information about their pregnancy and childbirth decisions. However, this feature was not intended to substitute the usual antenatal care, and no medication prescriptions, requesting laboratory tests, or imaging were offered via our mHealth. They could also write about their feelings and experiences publicly in the forum linked to the educational contents, and pregnant women had the opportunity to exchange their feelings with each other under the research team’s supervision. The mHealth application can also help women in expressing their feelings and symptoms due to the anonymity of this method of delivering the intervention [The control group received only routine prenatal care. Currently there are no specific guidelines in Iran, for providing care to pregnant women suffering from FOC. The routine prenatal care in Iran includes up to 8 prenatal visits, which in the study site would be provided to all pregnant individuals by midwives and obstetricians. Routine prenatal care includes regular visits to monitor women and fetal health. To better access women in the control group and limit in-person interaction due to the COVID-19 pandemic, we asked them not to uninstall the application from their mobile phones until birth and answer questionnaires after eight weeks and after childbirth. | PMC10619799 | ||
Statistical analyzes | REGRESSION | The data analyzed by IBM SPSS statistics version 25 and p-value > 0.05 was considered as a statistically significant level. To compare statistical differences of demographic data in intervention and control groups, an independent t-test, Chi-square test, and Fisher’s exact test were used. The repeated-measures analysis of variance (ANOVA) was used to compare the mean score of FOC between intervention and control groups at different time points (baseline, after 8 weeks, after childbirth). Linear regression models used to estimate the change in FOC and self-efficacy score in the intervention group compared to the control group in different time points. Also, for analyzing the birth mode, Chi-square were used to determine the differences between the groups. A Logistic regression model was also performed to estimate the odds of CS in the intervention group compared to the control group. | PMC10619799 | |
Ethical considerations | The ethics committee of Tehran University of Medical Sciences approved the research procedure (IR.TUMS.FNM.REC.1398.135). At the beginning of the study, the researchers provided the necessary explanations about the intervention and the study’s objectives to the participant. After receiving sufficient information from various aspects of the research, all participants provided a signed written informed consent, and they could leave at any stage of the research. Each woman was assigned a unique code to ensure the confidentiality of their medical information, which prevented the identification of the participants. | PMC10619799 | ||
Results | A total of 70 nulliparous women with FOC enrolled in the study in two intervention (n = 35) and control (n = 35) groups. There was no loss to follow-up, and no exclusion from the study based on our criteria, and although we prepared to refer participants in case of an emergency, no such contacts were made during the study period and all 70 participants were included in the final analysis. In this study, the mean age of participants in the intervention group was 24.3 years, and 25.6 years in the control group. The majority of women’s gestational age in the intervention and control groups at the beginning of the study was 28 weeks (40% in the intervention group and 45.7% in the control group). According to | PMC10619799 | ||
Characteristics of the participants. | (n = 70).*Fisher Exact Test**Chi square test***Independent t-test | PMC10619799 | ||
FOC | REGRESSION | A repeated-measures ANOVA with a Greenhouse-Geisser correction for within-subject effects of FOC scores showed that time and the group interaction effect is significant for this variable (time*group: F = 131, p < 0.001). To compare groups at different time-points (baseline, after 8 weeks, and after childbirth), linear regression model was used. There was no statistically significant difference in mean scores of FOC in the intervention and control groups at the baseline (p = 0.10). The result of linear regression model showed that on average the estimated score of FOC for individual in the intervention group is 21.14 scores lower than those in the control group (95% CI [-23.94, -18.34]; p <0.0001, R | PMC10619799 | |
Comparison of FOC scores in intervention and control groups at baseline, after 8 weeks and after childbirth. | PMC10619799 | |||
Effect of mHealth application on FOC score in intervention group compared to control group at different time points (n = 70). | SE | SE = Standard Error, CI = Confidence Interval, LL = lower Limit, UL = Upper Limit | PMC10619799 | |
Childbirth self-efficacy | REGRESSION | There was no statistically significant difference in mean scores of childbirth self-efficacy between the intervention and control groups at the baseline (p = 0.07). According to the result of linear regression it is estimated that on average those in the intervention group have an 85.60scores more than those in the control group after 8 weeks of intervention (95% CI [80.56, 90.64], P value <0.0001, R | PMC10619799 | |
Effect of mHealth application on self-efficacy score in intervention group compared to control group at baseline and 8 weeks after intervention (n = 70). | SE | SE = Standard Error, CI = Confidence Interval, LL = lower Limit, UL = Upper Limit | PMC10619799 | |
Birth mode | REGRESSION | Two intervention and control groups had a statistically significant difference in their birth mode (p = 0.03). The intervention group had a lower rate of CS than the control group (31.4% in the intervention group versus 60% in the control group). The result of the logistic regression showed that the odds of CS are approximately 3.27 times higher in the control group compared to the intervention group (95% CI 1.22, 8.75). The adjusted model for age, family income, education showed similar results. | PMC10619799 | |
Discussion | Tele-midwifery | This study aimed to determine the effect of an interactive mHealth application named Tele-midwifery based on education and continuous support provided by midwives on FOC, childbirth self-efficacy, and birth mode in primiparous women. Based on the results of this study, Tele-midwifery application reduced FOC, increased childbirth self-efficacy, and decreased the CS rate among the intervention group compared to the control group.Women in the intervention group received educational materials, including a broad range of information regarding pregnancy and childbirth, in order to enhance their knowledge and eliminate their misconceptions about childbirth, which contribute to FOC [Our intervention’s emphasis on continuity of care may be another explanation for the reduced FOC in the intervention group compared with the control group at the end of pregnancy and after childbirth [The method used in this study was a mHealth-based intervention that provided remote access to evidence-based healthcare, such as education and consultation for women with FOC. Using the mobile health applications to provide healthcare is an effective means of ensuring that professional healthcare is available, affordable, and accessible to all individuals, particularly pregnant women [ | PMC10619799 | |
Strengths and limitations of research | Tele-midwifery | This study was conducted during the COVID-19 pandemic; thus, it can be complicated to generalize the study’s results to normal conditions. Lack of access to childbirth preparation classes and the high risk of getting infected by in-person visits caused pregnant women to raise more concerns about their health. Therefore, one of the possible explanations for adherence to intervention, may be the accessibility of Tele-midwifery intervention during the COVID-19 crisis, which answered their needs and provided continuous care.In this study we did not capture the frequency and nature of interactions between participants and healthcare providers who delivered the continues support feature of mHealth intervention through the application. Consequently, the specific types of support, the average frequency of provider contact (such as interactions per day or week), and the potential impact of these interactions on maternal health outcomes remain unexplored in this study. Future research is needed to delve deeper into understanding the dynamics and potential benefits of such interactions for expecting mothers.According to the latest statistics available to the public, in Baharlou Hospital, there are approximately 350 births each month, comprising 38% CS [ | PMC10619799 | |
Implications for future research | PRETERM BIRTH | In this study, participants received continuous support for addressing their questions throughout the week. However, replicating such personalized attention on a larger scale could be challenging. Real-world implementation might lack sufficient qualified healthcare professionals in the field of obstetrics, potentially affecting intervention quality and adherence. Additionally, strategies to bridge the gap between controlled settings and real-world scenarios during scaling up need to be explored to maintain intervention quality. Future studies are also needed to investigate the effects of this study’s intervention by considering additional variables such as the number of antenatal care visits and child outcomes, including stillbirth and preterm birth. Recruiting multiparous and primiparous into future research can also be another area before implementing this study intervention in real settings. | PMC10619799 | |
Conclusion | Tele-midwifery | In this randomized clinical trial, women who received the Tele-midwifery intervention reported less FOC and more childbirth self-efficacy after receiving the Tele-midwifery application. Furthermore, the rate of CS decreased in the intervention group. Based on the results, the mHealth application can be considered a supportive treatment for women diagnosed with FOC childbirth, especially during crises such as the COVID-19 pandemic, which limits access to health settings due to preventive measures. | PMC10619799 |
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