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Nevin Manimala Statistics

Laparoscopic Removal of Nonseparated Cavitated Horn in Unicornuate Uterus: Surgical Aspects and Long-Term follow-up

Int J Fertil Steril. 2023 Feb 1;17(2):145-150. doi: 10.22074/ijfs.2022.543827.1231.

ABSTRACT

BACKGROUND: In unicornuate uterus cases, when the rudimentary horn is very close to the uterus and is firmly attached, laparoscopic surgery can be very challenging due to the danger of massive bleeding and the possiblity of damaging the healthy hemiuterus. The aim of study is to verify if the laparoscopic resection of the horn site of hematometra, when solidly attached to the unicornuate uterus, is safe and effective.

MATERIALS AND METHODS: This is a retrospective analysis of prospectively collected data in a tertiary referral centre. From 2005 to 2021, a total of 19 women were diagnosed with unicornuate uterus with cavitated noncommunicating horn (class II B). We reviewed the original documentations of the patients and created a database. The follow-up results were assessed by questionnaires answered by the patients. In all cases, the chosen treatment was: laparoscopic removal of the rudimentary horn together with the ipsilateral salpinx and reconstruction of the myometrium of the hemiuterus. Statistical Package for Social Science (SPSS) version 21.0 was used to perform data analysis. We decided to calculate continuous variables in terms of mean and standard deviation (SD) or as median and interquartile range (IQR), as appropriate. Instead, categorical variables were expressed in terms of percentage.

RESULTS: Five patients (12-18 years old) with unicornuate uterus and rudimentary horn with hematometra and broadly connected to the hemiuterus were operated laparoscopically. The surgical procedure was successfull in all cases. No major complications were recorded. Postoperative course was uneventfull. In the follow-up in all cases dysmenorrhea and pelvic pain disappeared. Three patients sought to become pregnant and have children. They had in total 4 pregnancies with 2 abortions in the 1st trimester and two pregnancies with premature births at the 34th and 36th weeks. No serious gestational complications were recorded and the pregnancies ended with caesarean sections due to breech presentation.

CONCLUSION: Overall, for the rudimentary horn solidly attached to the unicornuate uterus, the laparoscopic resection of the horn site of hematometra seems to be safe and effective.

PMID:36906833 | DOI:10.22074/ijfs.2022.543827.1231

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Effect of Endometrial Ablation by Thermal Balloon vs. Hysteroscopy Ablation on Amenorrhea Rates in Patients with Abnormal Uterine Bleeding: A Randomized Clinical Trial

Int J Fertil Steril. 2023 Feb 1;17(2):133-139. doi: 10.22074/ijfs.2022.550429.1275.

ABSTRACT

BACKGROUND: Abnormal uterine bleeding (AUB) that is any irregularity in menstrual cycles causes women to refer to clinics. This study aimed to compare the efficacy, safety, and complications of endometrial ablation by the thermal balloon (Cavaterm) method with the hysteroscopy loop resection method in the treatment of AUB.

MATERIALS AND METHODS: The present study is an open-label, randomized clinical trial that was performed in the two hospitals, Shahid Akbarabadi and Hazrat Rasoul Akram, of Tehran, Iran, from December 2019 to October 2020. Patients were randomly allocated to the two groups of interventions by a simple randomization method. The proportion of amenorrhea (as primary outcome) and consequent hysterectomy and patient satisfaction (as secondary outcomes) was assessed using the Chi-square test and independent t test.

RESULTS: There was no significant difference between the two groups in the baseline characteristics. The percentage of intervention failure was statistically higher in the hysteroscopy group (24%) in comparison with the Cavaterm group [8.2%, P=0.03, relative risk (RR)=1.63, 95% confidence interval (CI): 1.13-2.36]. Mean ± standard deviation of satisfaction based on the Likert score in the Cavaterm group and hysteroscopy group were 4.3 ± 1.21 and 3.7 ± 1.56, respectively, that showed a significant difference (P=0.04). Assessing the procedural complications, the rate of spotting, bloody discharge, and malodor discharge was significantly higher in the Cavaterm group. In contrast, postoperative dysmenorrhea is more common in the hysteroscopy group.

CONCLUSION: Cavaterm ablation is accompanied by a higher success rate of amenorrhea and patients’ satisfaction than hysteroscopy ablation (registration number: IRCT20220210053986N1).

PMID:36906831 | DOI:10.22074/ijfs.2022.550429.1275

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Evaluation of The Relationship between Cell-Free DNA Fetal Fraction of The Circulatory System and Fetal and Maternal Pregnancy Prognosis: A Prospective Study

Int J Fertil Steril. 2023 Feb 1;17(2):115-119. doi: 10.22074/ijfs.2022.535676.1169.

ABSTRACT

BACKGROUND: Non-invasive prenatal testing (NIPT), sometimes called noninvasive prenatal screening (NIPS), is a non-invasive prenatal genetic test using cell-free DNA in maternal blood. This method is used to diagnose fetal aneuploidy disorders such as Down syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13), which causes disability disorders or significant postpartum defects. The aim of this study was to investigate the relationship between high and low fetal fraction (FF) and prognosis of maternal pregnancy.

MATERIALS AND METHODS: In this prospective study, after obtaining informed consent, 10 ml of blood was collected from 450 mothers with singleton pregnancies with gestational age above 11 weeks (11-16) at the request of NIPT for cell-free DNA BCT test. After obtaining the test results, maternal and embryonic results were evaluated based on the amount of non-cellular DNA FF. Data analysis was performed by using SPSS software version 21 and independent t test, chi-square statistical tests.

RESULTS: Based on test results, 20.5% of women were nulli par. The mean FF index in the studied women was 8.3% with a standard deviation of 4.6. The minimum and maximum values were 0 and 27, respectively. The frequency of normal, low and high FFs was 73.2, 17.3 and 9.5%, respectively.

CONCLUSION: High FF has fewer risks to the mother and fetus than low FF. The use of FF level (high or low) can help us determining the prognosis of pregnancy and using it to better manage the pregnancy.

PMID:36906828 | DOI:10.22074/ijfs.2022.535676.1169

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Effect of CoQ10 Supplement on Spermogram Parameters and Sexual Function of Infertile Men Referred to The Infertility Center of Fatemieh Hospital, Hamadan, Iran, 2019: A Randomized Controlled Trial Study

Int J Fertil Steril. 2023 Feb 1;17(2):99-106. doi: 10.22074/ijfs.2022.544330.1234.

ABSTRACT

BACKGROUND: The aim of this study was to investigate the effects of the antioxidant supplement of CoQ10 and placebo in the male infertility treatment.

MATERIALS AND METHODS: The randomized controlled trial study was designed as a clinical trial. Samples in each group consisted of 30 members. The first group received 1 daily dose of 100 mg coenzyme Q10 capsules and the second group received a placebo treatment. Treatment in both groups lasted 12 weeks. Before and after the intervention of semen analysis, hormonal measurement of testosterone, prolactin, luteinizing hormone (LH), follicle-stimulating hormone (FSH) and thyroid stimulating hormone (TSH) were done. Sexual function was assessed before and after the intervention by using the International Index of Erectile Dysfunction questionnare.

RESULTS: The mean age of participants was 34.07 (5.26) years in the CoQ10 group and 34.83 (6.22) in the placebo one. Normal volume of semen (P=0.10), viscosity (P=0.55), sperm count (P=0.28), and sperm motility (P=0.33) in the CoQ10 group increased without statistically significant differences. But the normal sperm morphology increased with statistically significant differences in the CoQ10 group (P=0.01). There was an increase in normal FSH levels and testosterone levels in the CoQ10 group compared with the placebo patients, but these differences were not statistically significant (respectively P=0.58, P=0.61). The results also revealed that the scores of erectile function (P=0.95), orgasm (P=0.86), satisfaction with sexual intercourse (P=0.61), overall satisfaction (P=0.69) and the score of the International Index of Erectile Function (IIEF, P=0.82) were greater after the intervention in the CoQ10 group than in the placebo group although the difference was not statistically significant.

CONCLUSION: The use of CoQ10 supplement can improve sperm morphology; however, in other sperm parameters and also in some hormones increased after the intervention, this was not statistically significant and therefore the result is not conclusive (registration number: IRCT20120215009014N322).

PMID:36906826 | DOI:10.22074/ijfs.2022.544330.1234

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Reference values for interleukin-6 in the amniotic fluid of asymptomatic pregnant women

Acta Obstet Gynecol Scand. 2023 Apr;102(4):480-485. doi: 10.1111/aogs.14524.

ABSTRACT

INTRODUCTION: Nowadays, proinflammatory factors are considered to play an important role in the pathophysiology of threatened preterm labor or chorioamnionitis. The aim of this study was to establish the normal reference range for interleukin-6 (IL-6) levels in the amniotic fluid and to identify factors which may alter this value.

MATERIAL AND METHODS: Prospective study in a tertiary-level center including asymptomatic pregnant women undergoing amniocentesis for genetic studies from October 2016 to September 2019. IL-6 measurements in amniotic fluid were performed using a fluorescence immunoassay with microfluidic technology (ELLA Proteinsimple, Bio Techne). Maternal history and pregnancy data were also recorded.

RESULTS: This study included 140 pregnant women. Of those, women who underwent termination of pregnancy were excluded. Therefore, a total of 98 pregnancies were included in the final statistical analysis. The mean gestational age was 21.86 weeks (range: 15-38.7) at the time of amniocentesis, and 38.6 weeks (range: 30.9-41.4) at delivery. No cases of chorioamnionitis were reported. The log10 IL-6 values follow a normal distribution (W = 0.990, p = 0.692). The median, and the 5th, 10th, 90th, and 95th percentiles for IL-6 levels were 573, 105, 130, 1645, and 2260 pg/mL, respectively. The log10 IL-6 values were not affected by gestational age (p = 0.395), maternal age (p = 0.376), body mass index (p = 0.551), ethnicity (p = 0.467), smoking status (p = 0.933), parity (p = 0.557), method of conception (p = 0.322), or diabetes mellitus (p = 0.381).

CONCLUSIONS: The log10 IL-6 values follow a normal distribution. IL-6 values are independent of gestational age, maternal age, body mass index, ethnicity, smoking status, parity and method of conception. Our study provides a normal reference range for IL-6 levels in the amniotic fluid that can be used in future studies. We also observed that normal IL-6 values were higher in the amniotic fluid than in serum.

PMID:36906815 | DOI:10.1111/aogs.14524

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Comparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial – Statistical Analysis Plan

Acta Anaesthesiol Scand. 2023 Mar 11. doi: 10.1111/aas.14230. Online ahead of print.

ABSTRACT

The international ATLS (Advanced Trauma Life Support) guidelines recommend that all severely injured trauma patients receive supplemental oxygen based on very limited evidence. The TRAUMOX2 trial randomises adult trauma patients to a restrictive or liberal oxygen strategy for eight hours. The primary composite outcome consists of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome; ARDS). This manuscript presents the statistical analysis plan for TRAUMOX2. Patients are randomised 1:1 in variable block sizes of four, six and eight, stratified by including centre (prehospital base or trauma centre) and tracheal intubation at inclusion. The trial will include 1420 patients to be able to detect a 33% relative risk reduction with the restrictive oxygen strategy of the composite primary outcome with 80% power at the 5% significance level. We will conduct modified intention-to-treat analyses on all randomised patients and per-protocol analyses for the primary composite outcome and key secondary outcomes. The primary composite outcome and two key secondary outcomes will be compared between the two allocated groups using logistic regression reported as odds ratios (ORs) with 95% confidence intervals (CI) adjusted for the stratification variables as in the primary analysis. A P-value below 5% will be considered statistically significant. A Data Monitoring and Safety Committee (DMSC) has been established to conduct interim analyses after inclusion of 25% and 50% of the patients. This statistical analysis plan of the TRAUMOX2 trial will minimise bias and add transparency to the statistics applied in the analysis of the trial. The results will add evidence on restrictive and liberal supplemental oxygen strategies for trauma patients. This article is protected by copyright. All rights reserved.

PMID:36906804 | DOI:10.1111/aas.14230

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Safety of COVID-19 vaccination in pregnant women and their neonatal outcome: a narrative Review

J Matern Fetal Neonatal Med. 2023 Dec;36(1):2183750. doi: 10.1080/14767058.2023.2183750.

ABSTRACT

BACKGROUND: Even through the fact that pregnant women are more and more severely infected with COVID-19 disease, there are still doubts about vaccinating these people due to the lack of sufficient evidence base information. So in this systematic review, we decided to study vaccinated and unvaccinated pregnant women regarding maternal, fetal and neonatal complications and outcomes.

THE STRATEGY OF SEARCHING: Between 30 December 2019 and 15 October 2021, electronic searches were performed on the databases of PubMed, Scopus, Google Scholar, and Cochrane library by searching in English and free full text. Keywords searched included these: maternal outcome, neonatal outcome, pregnancy, and COVID-19 vaccination. Among 451 articles, finally, seven studies were included to study pregnancy outcomes in vaccinated women compared to unvaccinated for systematic review purposes.

RESULTS: In this study 30257 vaccinated women in their third trimester compared to 132339 unvaccinated women in terms of age, the root of delivery, neonatal adverse outcomes. There were no significant differences between two groups in terms of: IUFD, and 1 min Apgar score, C/S rate, and NICU admission between the two groups, however, the rate of SGA, IUFD, and also neonatal jaundice, asphyxia, and hypoglycemia was more significant in the unvaccinated group comparing to the vaccinated group as a result. Among them, the chance of preterm labor pain was reported more among vaccinated patients. Emphasizing that, except 7.3% of the case population, everyone in the second and third trimesters had been vaccinated with mRNA COVID-19 vaccines.

CONCLUSION: COVID-19 vaccination during the second and third trimesters appears to be the right choice due to the immediate impact of COVID-19 antibodies on the developing fetus and formation of neonatal prophylaxis, as well as the absence of adverse outcomes for both the fetus and mothers.

PMID:36906793 | DOI:10.1080/14767058.2023.2183750

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Efficacy and safety of the surgical treatments for lower calyceal stones: A systematic review and network meta-analysis

Int J Surg. 2023 Mar 4. doi: 10.1097/JS9.0000000000000062. Online ahead of print.

ABSTRACT

OBJECTIVE: Efficacy and safety of 5 common surgical treatments for lower calyceal (LC) stones were assessed for LC stones≤20 mm.

METHODS: A systematic literature search was conducted up to June 2020 using PUBMED, EMBASE and Cochrane Library. The study has been registered in PROSPERO, CRD42021228404. Randomized controlled trials evaluating efficacy and safety of 5 common surgical treatments for LC stones were collected, including percutaneous nephrolithotomy (PCNL), MiniPCNL (MPCNL), UltraminiPCNL (UMPCNL), extracorporeal shock wave lithotripsy (SWL) and retrograde intrarenal surgery (RIRS). Heterogeneity among studies was assessed by using the global inconsistency and local inconsistency. Both pooled Odds ratio (OR) along with 95% credible interval (CI) and the surface under the cumulative ranking curve (SUCRA) values, were calculated to assess the outcomes, paired comparisons of efficacy and safety of 5 treatments.

RESULTS: 9 peer-reviewed RCTs, comprising 1674 patients, in recent 10 years, were included. Heterogeneity tests showed no statistical significance, and a consistency model was chosen, respectively. The order of SUCRA values for efficacy was as follows: PCNL (79.4), MPCNL (75.2), UMPCNL (66.3), RIRS (29), and SWL (0). For safety: SWL (84.2), UMPCNL (82.2), RIRS (52.9), MPCNL (16.6) and PCNL (14.1).

CONCLUSION: In the current study, all 5 treatments are both effective and safe. Many factors must be considered to choose surgical treatments for LC stones≤20 mm; the results that we separate conventional PCNL into PCNL, MPCNL and UMPCNL make the questions even more controversial. However, relative judgements are still needed to be used as reference data in clinical managements. For efficacy, PCNL>MPCNL>UMPCNL>RIRS>SWL, SWL is statistically inferior to other 4 treatments, respectively. RIRS is statistically inferior to PCNL and MPCNL, respectively. For safety, SWL>UMPCNL>RIRS>MPCNL>PCNL, SWL is statistically superior to RIRS, MPCNL and PCNL, respectively. RIRS is statistically superior to PCNL. We cannot reach conclusions which surgical treatment is the best choice for all patients with LC stones≤20 mm; Therefore, tailored treatments based on individual patients still demand more attention than ever before for both patients and urologists.

PMID:36906759 | DOI:10.1097/JS9.0000000000000062

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Impact of two ketogenic diet types in refractory childhood epilepsy

Pediatr Res. 2023 Mar 11. doi: 10.1038/s41390-023-02554-w. Online ahead of print.

ABSTRACT

BACKGROUND: Ketogenic diet (KD) refers to any diet in which food composition induces a ketogenic state of human metabolism.

OBJECTIVE: To assess short- and long-term efficacy, safety, and tolerability of KD [classic KD and modified Atkins diet (MAD)] in childhood drug-resistant epilepsy (DRE) and to investigate the effect of KD on electroencephalographic (EEG) features of children with DRE.

METHODS: Forty patients diagnosed with DRE according to International League Against Epilepsy were included and randomly assigned into classic KD or MAD groups. KD was initiated after clinical, lipid profile and EEG documentation, and regular follow-up was done for 24 months.

RESULTS: Out of 40 patients with DRE, 30 completed this study. Both classic KD and MAD were effective in seizure control as 60% in classic KD group and 53.33% in MAD group became seizure free, and the remaining showed ≥50% seizure reduction. Lipid profile remained within acceptable levels throughout the study period in both groups. Adverse effects were mild and managed medically with an improvement of growth parameters and EEG during the study period.

CONCLUSIONS: KD is an effective and safe non-pharmacologic, non-surgical therapy for the management of DRE with a positive impact on growth and EEG.

IMPACT: Both common types of KD (classic KD and MAD) are effective for DRE, but unfortunately, nonadherence and dropout rates are frequent. High serum lipid profile (cardiovascular AE) is often suspected in children following a high-fat diet, but lipid profile remained in the acceptable level up to 24 months. Therefore, KD constitutes a safe treatment. KD had a positive impact on growth, despite inconsistent results of the KD’s effect on growth. In addition to showing strong clinical effectiveness, KD also considerably decreased the frequency of interictal epileptiform discharges and enhanced the EEG background rhythm.

PMID:36906721 | DOI:10.1038/s41390-023-02554-w

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Resilience and coping behaviour among adolescents in a high-income city-state during the COVID-19 pandemic

Sci Rep. 2023 Mar 11;13(1):4061. doi: 10.1038/s41598-023-31147-0.

ABSTRACT

The study aimed to determine the resilience of multi-ethnic, multi-cultural adolescent students in cosmopolitan Singapore, their coping abilities, and the impact on their social and physical activities during the COVID-19 pandemic and its association with their resilience. A total of 582 adolescents in post-secondary education institutes completed an online survey from June to November 2021. The survey assessed their sociodemographic status, resilience level using the Brief Resilience Scale (BRS) and Hardy-Gill Resilience Scale (HGRS), the impact of the COVID-19 pandemic on their daily activities, life settings, social life, social interactions, and coping ability in these aspects of life. Poor ability to cope with school life (adjusted beta = – 0.163, 95% CI – 1.928 to 0.639, p < 0.001), staying home (adjusted beta = – 0.108, 95% CI = – 1.611 to – 0.126, p = 0.022), sports (adjusted beta = – 0.116, 95% CI – 1.691 to – 0.197, p = 0.013) and friends (adjusted beta = – 0.143, 95% CI – 1.904 to – 0.363, p = 0.004) were associated with statistically significant low resilience level measured with HGRS. About half and a third of the participants reported normal and low resilience, respectively, based on BRS (59.6%/32.7%) and HGRS (49.0%/29.0%) scores. Adolescents of Chinese ethnicity and low socioeconomic status had comparatively lower resilience scores. Approximately half of the adolescents in this study had normal resilience despite the COVID-19 pandemic. Adolescents with lower resilience tended to have lower coping abilities. The study did not compare changes in the social life and coping behaviour of the adolescents due to COVID-19, as data on these aspects prior to the pandemic was unavailable.

PMID:36906711 | DOI:10.1038/s41598-023-31147-0