O-074 No methylome differences observed in IVF children born after embryo culture in different culture media

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
R Koeck ◽  
J Tost ◽  
F Busato ◽  
D Consten ◽  
J Van Echten-Arends ◽  
...  
Keyword(s):  
Dna Methylation ◽  
Embryo Culture ◽  
Missing Values ◽  
Culture Media ◽  
Controlled Trial ◽  
In Vitro Fertilisation ◽  
Control Group ◽  
P Value ◽  
Artificial Environment ◽  
Increased Risk

Abstract Study question Does human embryo culture in different IVF culture media lead to DNA methylation alterations in IVF offspring? Summary answer Genome-wide analyses identified no significant DNA methylation differences between culture medium groups in IVF children (neonates or 9-year olds) from two culture media studies. What is known already During in vitro fertilisation (IVF) treatments, embryos undergo preimplantation development in an artificial environment, while concurrently undergoing epigenetic reprogramming. Adversity during this period, such as peri-conception calorie restriction, has been linked to persistent DNA methylation aberrations and increased risk of cardiometabolic disease. Early environmental adversity is suspected in IVF offspring as they are born with lower birthweights and show increased risk of cardiometabolic dysfunction in adulthood as compared to their naturally-conceived counterparts. This is further supported by the observation from two culture media trials (MEDIUM0 and MEDIUM1) that embryo culture in different culture media leads to differences in birthweight. Study design, size, duration We recruited singleton offspring from two IVF culture media trials. The MEDIUM0 study, a pseudo-randomized trial comparing G3 (Vitrolife) and K-SICM (Cook), was conducted from 2003-2006. At the 9-year follow-up, saliva was collected (cohort-A). The MEDIUM1 study, a multi-center randomized controlled trial comparing G5 (Vitrolife) and HTF (Lonza), was conducted from 2010-2012. Umbilical cord blood (UCB) was collected at birth (cohort-B). Participants/materials, setting, methods DNA methylation was analysed in 120 saliva samples (65 G3, 55 Cook) and 106 UCB samples (47 HTF, 59 G5) using the Infinium MethylationEPIC array (Illumina). Mixed effects linear models, correcting for (gestational) age, sex, sample composition and batch effects alongside maternal age, pregnancy complications and IVF centre for cohort-B, were implemented at single or aggregated sites. Methylation outliers were defined as values over three interquartile ranges below or above 25th and 75th percentiles respectively. Main results and the role of chance 111 of the 120 saliva samples (60 G3, 51 Cook) and 105 of the 106 UCB samples (47 HTF, 58 G5) passed our quality control criteria. We filtered sites on sex chromosomes, and based on quality, proximity to single-nucleotide polymorphisms, and proportion of missing values, leaving 650,000-700,000 of the 850,000 sites included on the EPIC array for our analyses. To account for heterogeneity in the cellular composition of our samples we estimated their cell compositions using a reference-based approach. First, we investigated individual CpG sites, finding no differentially methylated sites in either cohort after correction for multiple testing (false discovery rate adjusted p. value threshold < 0.1). Sites were then aggregated into regions based on their allocations to genes, promoters and CpG islands. No differentially methylated regions were identified in either cohort. A targeted analysis of DNA methylation of imprinting genes showed no differentially methylated sites or regions. To examine the contribution of stochastic epigenetic alterations we quantified the number of methylation outliers per sample. Although this revealed a predominance of hypomethylation outliers, there was no difference in the total number or distribution of DNA methylation outliers between the two culture media groups of cohort-A and cohort-B. Limitations, reasons for caution This analysis is currently limited by the lack of comparison to a naturally-conceived control group. As such, we cannot yet conclude whether IVF embryo culture, in any medium, is associated with DNA methylation aberrations. Additionally, given the large number of comparisons, we may lack power to detect small differences. Wider implications of the findings Although there are disparities in birth weight and childhood growth after embryo culture in different media, we observed no DNA methylation alterations preserved postnatally. Whether DNA methylation of these individuals deviates from that of naturally-conceived individuals will be determined in the near future. Trial registration number MEDIUM1: NTR 1979 /NL1866 (Netherlands Trial Registry)

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Neurodevelopment in Children Exposed to Zika Virus: What Are the Consequences for Children Who Do Not Present with Microcephaly at Birth?

Viruses ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1427
Author(s):  
Paula Sobral da Silva ◽  
Sophie Eickmann ◽  
Ricardo Ximenes ◽  
Celina Martelli ◽  
Elizabeth Brickley ◽  
...  
Keyword(s):  
Neurological Examination ◽  
Zika Virus ◽  
Control Group ◽  
P Value ◽  
Zikv Infection ◽  
Clinical Neurological Examination ◽  
Cognitive Delay ◽  
Increased Risk ◽  
Neurodevelopmental Impairment ◽  
The Impact

The relation of Zika virus (ZIKV) with microcephaly is well established. However, knowledge is lacking on later developmental outcomes in children with evidence of maternal ZIKV infection during pregnancy born without microcephaly. The objective of this analysis is to investigate the impact of prenatal exposure to ZIKV on neuropsychomotor development in children without microcephaly. We evaluated 274 children including 235 ZIKV exposed and 39 controls using the Bayley-III Scales of Infant and Toddler Development (BSIDIII) and neurological examination. We observed a difference in cognition with a borderline p-value (p = 0.052): 9.4% of exposed children and none of the unexposed control group had mild to moderate delays. The prevalence of delays in the language and motor domains did not differ significantly between ZIKV-exposed and unexposed children (language: 12.3% versus 12.8%; motor: 4.7% versus 2.6%). Notably, neurological examination results were predictive of neurodevelopmental delays in the BSIDIII assessments for exposed children: 46.7% of children with abnormalities on clinical neurological examination presented with delay in contrast to 17.8% among exposed children without apparent neurological abnormalities (p = 0.001). Overall, our findings suggest that relative to their unexposed peers, ZIKV-exposed children without microcephaly are not at considerably increased risk of neurodevelopmental impairment in the first 42 months of life, although a small group of children demonstrated higher frequencies of cognitive delay. It is important to highlight that in the group of exposed children, an abnormal neuroclinical examination may be a predictor of developmental delay. The article contributes to practical guidance and advances our knowledge about congenital Zika.

scholarly journals Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 463
Author(s):  
Mar Gomis-Pastor ◽  
Sonia Mirabet Perez ◽  
Eulalia Roig Minguell ◽  
Vicenç Brossa Loidi ◽  
Laura Lopez Lopez ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Patient Experience ◽  
Mobile Application ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
P Value ◽  
Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

scholarly journals Impaired atrial electromechanical coupling in lichen planus patients

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
I Jafaripour ◽  
Z Aryanian ◽  
S Hosseinzadeh ◽  
R Pourkia ◽  
MM Ansari Ramandi ◽  
...  
Keyword(s):  
Lichen Planus ◽  
Electromechanical Coupling ◽  
Wave Dispersion ◽  
Tissue Doppler ◽  
P Wave ◽  
Control Group ◽  
P Value ◽  
P Wave Dispersion ◽  
Increased Risk ◽  
Significant Difference

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Lichen planus (LP) which is a chronic inflammatory disease can cause impaired atrial electromechanical coupling, leading to increased risk of atrial fibrillation. Purpose The present study aimed to evaluate atrial electromechanical coupling in LP patients by using electrocardiography (ECG) and echocardiography. Methods Forty-six LP patients were investigated in this cross-sectional case-control study. The control group comprised healthy individuals selected in age and gender-matched manner. Echocardiography and ECG were done for all patients to show inter and intra-atrial electromechanical delays and P wave dispersion respectively. The electromechanical delays were calculated by using the difference between the delays from the onset of the P wave on ECG to the onset of A wave on tissue Doppler recordings of the different areas. Results The baseline characteristics of the case and control group were similar and did not differ significantly. The P wave dispersion was 45.63 ± 3.48 milliseconds in the LP group in comparison to 36.56 ± 2.87 milliseconds in the control group (p &lt; 0.001). As shown in the table, the intra and inter-atrial electromechanical delays were also significantly prolonged in LP patients when compared to the control group (p &lt; 0.001). There was no significant difference between the left and right ventricular systolic function and diastolic function of the two groups. Conclusion The results of the study indicate the presence of significant impaired atrial electromechanical coupling in patients with LP confirmed by both electrocardiographic and echocardiographic tools. Electromechanical delays Case N = 46 (mean ± SD) Control N = 46 (mean ± SD) P value Septal - PA (msec) 59.71 ± 13.24 44.39 ± 11.07 0.002 Lateral - PA (msec) 55.71 ± 13.26 48.89 ± 11.21 0.009 Tricuspid - PA (msec) 52.37 ± 13.12 43.28 ± 10.58 0.002 Inter-atrial delay (msec) (lateral PA−RV PA) 8.47 ± 1.62 6.37 ± 1.36 &lt;0.001 Intra-atrial delay (msec) (LA) [lateral PA−septal PA] 4.80 ± 1.48 3.83 ± 0.82 &lt;0.001 Intra-atrial delay (msec) (RA) [septal PA−RV PA] 3.91 ± 0.96 2.02 ± 0.71 &lt;0.001 PA Delay from the onset of the P wave on ECG to the onset of A wave on tissue Doppler, N: number, SD: Standard Deviation, LA: Left Atrium, RA: Right Atrium, RV: Right Ventricle

Effectiveness of sustained natural apophyseal glides in females with cervicogenic headache: A randomized controlled trial

2021 ◽  
pp. 1-7
Author(s):  
Muhammad Kashif ◽  
Nosheen Manzoor ◽  
Rimsha Safdar ◽  
Hafsa Khan ◽  
Maryam Farooq ◽  
...  
Keyword(s):  
Treatment Group ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Placebo Treatment ◽  
Cervicogenic Headache ◽  
Control Group ◽  
P Value ◽  
Head Positioning ◽  
Significant Difference ◽  
Neck Disability

BACKGROUND: Cervicogenic headache (CGH) is a common condition that results in significant disability. To treat this dysfunction, Mulligan described sustained natural apophyseal gliders (SNAGs) as a manual therapy approach. However, only inconclusive short-term evidence exists for treating CGH with SNAGs. OBJECTIVE: The present study aims to investigate the effect of SNAGs in the treatment of CGH. METHODS: Fourty female patients ranging from 20 to 40 years with CGH were randomly assigned to two groups: 20 in a treatment group and 20 in a control group. SNAGs were applied to the treatment group while the control group received placebo treatment. Both groups received their respective treatment for 20 minutes, alternately three times per week, for a total of 12 times in four weeks. The outcome measures were the Neck Disability Index (NDI) and the Visual Analogue Scale (VAS). Participants were assessed at baseline and at the end of each week. The data was analyzed using SPSS version 20. Independent t-testing was used to reveal changes between groups. One-way ANOVA was used to determine changes within groups. The level of significance was P< 0.05. RESULTS: Twenty participants (100%) in the treatment group and 17 (85%) in the control group had a history of headache aggravation with active movements or passive head positioning. There was no significant difference at baseline (p> 0.05), indicating that both groups were homogeneous at the time of recruitment. The p value (p< 0.05) showed a significant difference in pain and level of disability at three and four weeks (p< 0.05) in patients treated with SNAGs. However, the cervical range of motion (ROM) showed a statistically significant improvement in flexion and extension in the treatment group (p< 0.05) while there was no significant improvement in side flexion and rotation ROM in both groups (p> 0.05). CONCLUSION: This study found that SNAGs were effective in reducing pain and neck disability and improved ROM in females with CGH.

P–227 Fatty acid regulation of Nrf2/Keap1 pathway during mouse preimplantation embryo development

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
G Dionne ◽  
A J Watson ◽  
D H Betts ◽  
B A Rafea
Keyword(s):  
Oleic Acid ◽  
Fatty Acid ◽  
Palmitic Acid ◽  
Embryo Development ◽  
Embryo Culture ◽  
Preimplantation Embryo ◽  
Culture Media ◽  
Control Group ◽  
Blastocyst Development ◽  
Preimplantation Embryo Development

Abstract Study question Our objective is determining whether supplementing embryo culture media with palmitic acid and/or oleic acid impacts Nrf2/Keap1 antioxidant response pathways during preimplantation mouse embryo development. Summary answer Supplementation of embryo culture media with palmitic acid increases cellular Nrf2 levels per embryo after 48-hour culture, while oleic acid reverses this effect. What is known already Obese women experience higher incidence of infertility than women with healthy BMIs. The obese reproductive tract environment supporting preimplantation embryo development is likely to include enhanced free fatty acid (FFA) levels and increased accumulation of reactive oxygen species. Exposure to palmitic acid (PA) in vitro significantly impairs mouse embryo development while increasing ER stress mRNAs. Oleic acid (OA) reverses these effects. To further define effects of FFA exposure, we are characterizing the influence of FFAs on the Nrf2–Keap1 pathway and its downstream antioxidant defense systems. We hypothesize that PA treatment induces Nrf2-Keap1 activity, while OA treatment alleviates pathway activity. Study design, size, duration Female CD–1 mice (4–6 weeks) were super-ovulated via intraperitoneal injections of PMSG, followed 48 hours later by hCG. Female mice were mated with male CD–1 mice (6–8 months) overnight. Females were euthanized using CO2 and two-cell embryos were collected by flushing oviducts. Two-cell embryos were placed into KSOMaa-based treatment groups: 1) BSA (control); 2) 100µM PA; 3) 100µM OA; 4) 100µM PA+OA, and cultured for 48 hours (37 °C; 5% O2, 5% CO2, 90% N2). Participants/materials, setting, methods After 48-hour embryo culture, developmental stages of all mouse embryos were recorded. Immunofluorescence analysis of Nrf2 and Keap1 localization was performed for embryo treatments (BSA, 100µM PA, 100µM OA & 100µM PA+OA) using rabbit polyclonal anti-Nrf2 antibody, with Rhodamine-Phalloidin and DAPI staining. Embryos were imaged using confocal microscopy and Nrf2-positive cells were counted using ImageJ. Nrf2 and Keap1 mRNA abundances were assessed after culture in each treatment condition using RT-qPCR and the delta-delta Ct method. Main results and the role of chance Inclusion of 100µM PA in embryo culture significantly decreased blastocyst development frequency from 70.06±16.38% in the BSA (control) group to 11.61±8.19% in the PA-treated group (p &lt; 0.0001). Embryo culture with 100µM OA and 100µM PA+OA co-treatment did not significantly impair blastocyst development (OA: 61.59±8.07%, p = 0.4053; PA+OA: 63.53±7.63%, p = 0.6204). Embryo culture with PA treatment significantly increased the mean percentage of Nrf2-positive cells to 56.83±30.49% compared with 21.22±15.63% in the control group (p &lt; 0.0001). Conversely, 100µM OA and 100µM PA+OA treatments did not significantly affect Nrf2-positive cell frequencies compared with the control group (OA: 33.28±21.83%, p = 0.1825; PA+OA: 34.84±12.66%, p = 0.0691). Immunofluorescence results show that treating embryos with 100µM PA for 48 hours results in increased levels of cellular Nrf2, while combining 100µM PA with 100µM OA reversed these effects. Preliminary qPCR analysis showed no significant differences in Nrf2 or Keap1 relative transcript abundance between any embryo treatment groups. Nrf2 and Keap1 mRNA levels were both higher after embryo culture with 100µM OA than all other culture groups (p = 0.6268; p = 0.3201). Notably, Keap1 relative transcript levels dropped to undetectable levels after culture with 100µM PA, which suggests an increase in Nrf2 activation.Limitations, reasons for caution: While immunofluorescence localization of Nrf2/Keap1 provides insight into how the proteins behave during preimplantation embryo development, confocal images cannot determine protein-protein interactions or activity levels. Similarly, transcript information from RT-qPCR analysis only provides information about Nrf2 and Keap1 at the transcript level. Nrf2 activity will be assessed via downstream targets. Wider implications of the findings: The Nrf2–Keap1 pathway coordinates numerous cellular defence mechanisms, and is implicated in various diseases, including cancer. Establishing an impact of free fatty acid exposure on Nrf2–Keap1 during preimplantation embryo development will provide valuable information regarding the effects of maternal obesity on outcomes for embryos produced from these patients. Trial registration number Not applicable

Abstract P550: High Uric Acid Levels Correlate With Treatment- Resistant Hypertension

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Badhma Valaiyapathi ◽  
Mohammed Siddiqui ◽  
Suzanne Oparil ◽  
David A Calhoun ◽  
Tanja Dudenbostel
Keyword(s):  
Uric Acid ◽  
Retrospective Study ◽  
Resistant Hypertension ◽  
Missing Values ◽  
Antihypertensive Agents ◽  
Treatment Resistance ◽  
Patient Characteristics ◽  
Control Group ◽  
Increased Risk ◽  
The University

Background: Serum uric acid (sUA) levels have been found to be positively associated with increased risk of hypertension (HTN), independent of other cardiovascular risk factors. The role of sUA elevation in patients with resistant hypertension (RHTN) is unknown. We hypothesized that sUA levels are higher in RHTN patients compared to patients with controlled HTN. Methods: This retrospective study included, 140 patients from the University of Alabama at Birmingham Hypertension Clinic. Patient characteristics including body mass index (BMI), office blood pressure (BP) and sUA levels were analyzed. RHTN was defined as office BP > 140/90 mmHg on ≥ 3 or more different antihypertensive agents including a diuretic. Patients with RHTN were compared with a control group with controlled hypertension. Patients with sUA levels <3 mg/dl, who were on treatment with allopurinol, and those with missing values were excluded from the study. Results: Patient characteristics of 91 included patients were: 53.4% female, 40.7% African American, mean age 58.8 ± 12.4 years, mean BMI 33.1 ± 7.5 kg/m 2 , mean sUA 6.6 ± 1.9 mg/dL. Mean sUA was higher among RHTN patients compared to the control group (p = 0.0031). Treatment resistance was found to be strongly correlated with sUA levels of ≥ 6 mg/dl (p = 0.0065). Conclusion: In this retrospective study, sUA levels were found to be significantly higher among resistant HTN patients compared to controlled HTN patients, indicating that high sUA levels (≥ 6 mg/dl) may play a role in treatment resistance among hypertensive patients.

scholarly journals Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients

2018 ◽  
Vol 40 (2) ◽  
pp. 143-150 ◽  
Author(s):  
Larissa Sgaria Pacheco ◽  
Valter Duro Garcia ◽  
Ronivan Luis Dal Prá ◽  
Bruna Doleys Cardoso ◽  
Mariana Ferras Rodrigues ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Controlled Trial ◽  
Calcineurin Inhibitors ◽  
Control Group ◽  
P Value ◽  
Kidney Transplant Recipients ◽  
Positive Serology ◽  
Open Label ◽  
Adult Kidney ◽  
Group 1

ABSTRACT Introduction: Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients. Method: This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV-positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors. Results: Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between group (p-value G=0.286). Group 1 showed a higher incidence of dyslipidemia (p=0.03) and proteinuria events (p=0.01), while no difference was observed in the incidence of anemia (p=0.17), new onset of post-transplant diabetes mellitus (p=1.00) or urinary tract infection (p=0.60). The mean eGFR was similar in both groups. Conclusion: Our study did not show viral load decrease after conversion to EVR with maintenance of antiproliferative therapy.

scholarly journals Effect of a breastfeeding educational intervention: a randomized controlled trial

2020 ◽  
Vol 28 ◽  
Author(s):  
Erdnaxela Fernandes do Carmo Souza ◽  
Alfredo Almeida Pina-Oliveira ◽  
Antonieta Keiko Kakuda Shimo
Keyword(s):  
Randomized Controlled Trial ◽  
Educational Intervention ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Postpartum Women ◽  
Significance Level ◽  
Randomized Controlled

Objective: to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women. Method: this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer’s Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24. Results: the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group. Conclusion: the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR – 8p9v7v.

scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Lactating Women ◽  
Randomized Controlled ◽  
Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

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