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Post-marketing safety evaluation of recombinant anti-rho (D) immunoglobulin for the prevention of maternal rh-isoimmunization: A prospective, multi-centre, phase IV study 重组抗 rho (D) 免疫球蛋白用于预防母体 rh 异种免疫的上市后安全性评估:前瞻性多中心 IV 期研究
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.090
Pratik Shah, Sweety Saigal, S. N. Naik, Shrinivas N. Gadappa, Swati Kochar, Lakshmikantha G Lakshmikantha, Ravindra S. Pukale, Kishma Vinod
AntiD is a recombinant anti-D immunoglobulin approved as an immunoprophylaxis treatment in Rh-negative mothers carrying an Rh-positive fetus. This study was conducted to assess the safety and tolerability of AntiD in clinical settings. This was a prospective, multicenter, phase IV, post-marketing safety study of AntiD. The study was conducted at 29 hospitals in India as per regulatory requirements. Three hundred eligible Rh-negative women were administered a single intramuscular dose of either 150 mcg or 300 mcg AntiD within 72 hours of a sensitizing event as per the approved indication. Safety and tolerability were evaluated based on the assessment of adverse events (AEs) and serious adverse events (SAEs) reported during the study.Out of the 300 participants enrolled, 290 completed the study procedures. A total of 54 AEs and 34 treatment-emergent adverse events (TEAEs) were reported by 47 (15.7%) and 30 (10.0%) participants, respectively. Most reported TEAEs were mild, unrelated to the study drug, and were completely resolved during the study. Except for two participants with clinically significant hematological and urinalysis findings consistent with their underlying medical conditions, none of the participants exhibited abnormal clinical or laboratory parameters. Based on the assessment of the different safety parameters, AntiD administered at a dose of either 150 mcg or 300 mcg did not raise any new or significant safety concerns. The current study demonstrated that AntiD is well-tolerated and safe to use for anti-D prophylaxis as per product label indications for the prevention of Rh-isoimmunization in a clinical setting.
AntiD 是一种重组抗 D 免疫球蛋白,已被批准用于怀有 Rh 阳性胎儿的 Rh 阴性母亲的免疫预防治疗。这项研究旨在评估 AntiD 在临床环境中的安全性和耐受性。这是一项前瞻性、多中心、IV 期、AntiD 上市后安全性研究。根据监管要求,该研究在印度 29 家医院进行。根据批准的适应症,300 名符合条件的 Rh 阴性妇女在发生致敏事件 72 小时内接受了 150 微克或 300 微克 AntiD 的单次肌肉注射。根据研究期间报告的不良事件(AE)和严重不良事件(SAE)评估安全性和耐受性。共有 47 名参与者(15.7%)和 30 名参与者(10.0%)分别报告了 54 例 AE 和 34 例治疗突发不良事件(TEAE)。大多数报告的 TEAE 均为轻微不良反应,与研究药物无关,并在研究期间完全缓解。除了两名参与者的血液学和尿液分析结果与他们的基础疾病相符,具有临床意义外,其他参与者的临床或实验室参数均未出现异常。根据对不同安全性参数的评估,按 150 微克或 300 微克的剂量服用 AntiD 不会引起任何新的或重大的安全性问题。目前的研究表明,AntiD 的耐受性良好,可安全用于抗 D 预防,符合产品标签上关于在临床环境中预防 Rh 异种免疫的适应症。
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引用次数: 0
Vacuum-assisted caesarean delivery assessment of maternal & fetal outcome 真空辅助剖腹产对产妇和胎儿结局的评估
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.080
Manisha Agarwal, Sweekrati Solanki, Sumedha Sachau
: The baby is delivered via incisions made in the mother's abdomen and uterus during a Caesarean delivery, sometimes known as a C-section. Whether medically necessary or elective, caesarean sections have increased sharply in recent decades all throughout the world, exceeding the WHO-recommended 10-15% rate. Every effort should be taken to give cesarean sections to women in need rather than aiming to achieve a target rate, according to a 2015 WHO statement. Therefore, we must investigate the strategies that can improve CD's maternal and neonatal health condition. This study compares the outcomes for the mother and the newborn in the vacuum-assisted CD and manual CD groups.: A progressive study was conducted at Lucknow's Green cross Hospital between June 2012 and April 2018. 500 pregnant ladies took part in this study as participants. This research was approved by the institutional human ethical committee. 250 caesarean sections were performed as part of this cohort study, each with vacuum assistance utilizing a soft cup vacuum extractor on the fetal scalp and manual removal of the skull as usual with fundal compression as support. Due to the absence of uterine activity and amniotic fluid, all of the patients underwent preplanned caesarean sections. The study's findings showed that manual extraction Caesarean birth is inferior to vacuum-assisted Caesarean delivery. Additionally, it was noted that Vacuum Assisted Caesarean Delivery resulted in less uterine incision extension, estimated blood loss, and maternal discomfort. : There was no difference between Vacuum and Manual Extraction caesarean deliveries in terms of Apgar Score, the requirement for infant resuscitation, or admission to the NICU.
:剖腹产:在剖腹产(有时也称为剖腹产)过程中,婴儿通过在母亲腹部和子宫上的切口娩出。近几十年来,无论是医学需要还是选择性剖腹产,全世界的剖腹产率都急剧上升,超过了世界卫生组织建议的 10-15%。根据 2015 年世卫组织的一份声明,应尽一切努力让有需要的妇女接受剖腹产,而不是以达到目标率为目标。因此,我们必须研究能够改善剖宫产产妇和新生儿健康状况的策略。本研究比较了真空辅助剖腹产组和人工剖腹产组对产妇和新生儿的影响:2012年6月至2018年4月期间,勒克瑙绿色十字医院开展了一项渐进式研究。500 名孕妇作为参与者参与了这项研究。该研究获得了机构人类伦理委员会的批准。作为这项队列研究的一部分,共进行了 250 例剖腹产手术,每例手术均使用软杯真空抽吸器对胎儿头皮进行真空辅助,并像往常一样以人工方式去除头骨,同时以压迫宫底作为支撑。由于没有子宫活动和羊水,所有患者都接受了预先计划的剖腹产。研究结果表明,人工拔管剖腹产不如真空辅助剖腹产。此外,研究还注意到,真空辅助剖腹产的子宫切口延伸较小,估计的失血量和产妇的不适感也较少。 在阿普加评分、婴儿复苏要求或进入新生儿重症监护室方面,真空辅助剖腹产和人工抽取剖腹产没有区别。
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引用次数: 0
De novo thoracic endometriosis in a menopausal women 更年期妇女新发胸腔子宫内膜异位症
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.095
U. Merchant, Ashwini Neelesh Desai, Gayatri Rao
Endometriosis is very common in reproductive age group. Since it is an estrogen dependent problem it is generally believed that it denotes “active ovarian function” and is “healed” after menopause. Most commonly endometrial tissue is found in ovaries resulting in the formation of chocolate cysts but it can also be found in extrapelvic sites. In this case report we will discuss endometriosis after menopause. Pulmonary endometriosis is a rare form of thoracic endometriosis. We describe a case of a 54-year-old woman with surgical menopause with recurrent episodes of haemoptysis, chest pain and dyspnea. Her Chest CT revealed multiple small pulmonary nodules. Biopsy from left lung lesion suggested endometriosis.
子宫内膜异位症在育龄人群中非常常见。由于子宫内膜异位症是一种依赖雌激素的问题,一般认为它表示 "卵巢功能活跃",并在绝经后 "痊愈"。最常见的是子宫内膜组织在卵巢中形成巧克力囊肿,但也可在盆腔外部位发现。在本病例报告中,我们将讨论绝经后的子宫内膜异位症。肺部子宫内膜异位症是一种罕见的胸部子宫内膜异位症。我们描述了一例 54 岁女性的病例,她因手术绝经,反复发作咯血、胸痛和呼吸困难。胸部 CT 显示她有多个肺部小结节。左肺病灶活检提示子宫内膜异位症。
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引用次数: 0
Umbilical cord variables in relation to gestational age by using ultrasonography in normal pregnancy and PIH women 通过超声波检查正常妊娠和 PIH 妇女的脐带变量与胎龄的关系
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.077
Khizer Hussain Afroze M, Lakshmiprabha Subhash R
To determine whether the antenatal assessment of CSA of umbilical cord variables is different in PIH compared with healthy pregnant women by using ultrasonography and to assess its relationship with gestational age.This study was conducted in the Department of Radio-diagnosis, Sri Siddhartha Medical College, among 600 (300 normal &300 PIH) pregnant women who underwent a routine prenatal gestational sonogram ranging from 28 to 39 weeks of age.There was a significant difference observed between two groups in all umbilical cord variables except umbilical artery area. Mean ± S.D of the CSA of the umbilical cord variables for each gestational age were studied in normal and PIH women.We found that the mean value of UCA and WJA was increased till 36 weeks then it decline sharply in the normal group whereas in PIH group, the mean value of UCA increases till 36 weeks then it attain plateau and the mean value of WJA increases even after 36 weeks. Our study was first of its kind to document the CSA of UC variables and their growth pattern according to gestation age, which can be used as an informational basis for both normal and PIH pregnant women.
本研究在斯里兰卡悉达多医学院放射诊断系进行,对 600 名(300 名正常和 300 名 PIH)孕妇进行了产前常规超声波检查,这些孕妇的年龄从 28 周到 39 周不等。我们发现,正常组 UCA 和 WJA 的平均值在 36 周前一直在增加,然后急剧下降;而在 PIH 组,UCA 的平均值在 36 周前一直在增加,然后趋于平稳,WJA 的平均值甚至在 36 周后仍在增加。我们的研究首次记录了 UC 变量的 CSA 及其随孕龄的增长模式,可为正常和 PIH 孕妇提供参考依据。
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引用次数: 0
Marvel drug for infertility!! 治疗不孕症的神奇药物
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.087
Eppalla Sravani, Janaki Vellanki
: Comparative study of Dydrogesterone versus oral sustained release micronized hydroxy-progesterone for support of luteal phase.: A randomized controlled trial, performed from March 2022 to April 2023. 200 women between 18–40 years of age attending infertility OPD at Gandhi hospital were enrolled in this study. Subjects were randomized and were given either oral dydrogesterone or oral sustained release micronized hydroxy-progesterone. Statistical analysis was done accordingly.In the present study, oral dydrogesterone was demonstrated to be superior than sustained release micronized hydroxy-progesterone, with UPT positive rates being 83% and 30% respectively. Dydrogesterone given orally was tolerated well with similar safety profile to sustained release micronized hydroxy-progesterone.Our study results depicted the use of dydrogesterone to be effective when compared to oral sustained release micronized hydroxy-progesterone in terms of luteal phase support. Dydrogesterone is hailed to be superior in regards of positive pregnancy rates in the current study.
:黄体期黄体酮与口服缓释微粒化羟孕酮的比较研究:这是一项随机对照试验,于 2022 年 3 月至 2023 年 4 月进行。200 名年龄在 18-40 岁之间、在甘地医院不孕症门诊就诊的女性被纳入本研究。受试者被随机分为口服地屈孕酮或口服缓释羟孕酮两种。在本研究中,口服地屈孕酮的效果优于缓释微粒化羟孕酮,UPT阳性率分别为83%和30%。我们的研究结果表明,与口服缓释微粒化羟孕酮相比,使用地屈孕酮对黄体期的支持更为有效。在目前的研究中,地屈孕酮被认为在阳性妊娠率方面更胜一筹。
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引用次数: 0
Primary ovarian insufficiency- An overview: Part 2 diagnosis and management 原发性卵巢功能不全--概述:第二部分 诊断和管理
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.074
R. Mondal, Mouli Nandi, Priyadarshi Mandal
Loss of normal ovarian function before the age of 40 characterizes primary ovarian insufficiency (POI), sometimes called premature ovarian failure or early menopause. Many women all around the globe deal with this serious reproductive health issue. The purpose of this study is to provide a broad perspective on how to identify and treat primary ovarian insufficiency. Clinical symptoms, hormone profiles, and ovarian imaging all play a role in making a diagnosis of POI. Genetic predisposition, autoimmune disease, and medical intervention are all possible origins. Counseling and treatment techniques for afflicted women can only be used when a timely and correct diagnosis has been made. Hormone replacement treatment (HRT) for symptom alleviation, avoidance of long-term consequences including osteoporosis and cardiovascular disease, and preservation of fertility are all part of the management of postmenopausal irritability (POI). To reduce the severity of menopausal symptoms and safeguard bone health, oestrogen replacement treatment is needed. HRT selection should be patient-specific, taking into account factors like as age, co-morbidities, and individual preferences. If a young woman is diagnosed with POI and she wants to have children in the future, she and her doctor should talk about fertility preservation strategies such oocyte or ovarian tissue cryopreservation. The latest treatments and possible revolutionary methods to POI management are also discussed in this overview. Stem cell therapy, ovarian tissue transplantation, and hormone manipulation are all examples of such unproven methods. While these treatments are still in their infancy, they show promise for the future of POI management. In conclusion, this review article gives a comprehensive, up-to-date explanation of how primary ovarian insufficiency is diagnosed and treated. Early detection, proper counselling, and individualised treatment plans are emphasised for afflicted females. The reproductive and overall health results of these people may be improved with a deeper knowledge of the processes producing POI and the development of more effective medicines.
40 岁前丧失正常卵巢功能是原发性卵巢功能不全(POI)的特征,有时也称为卵巢早衰或更年期提前。全球许多妇女都面临着这一严重的生殖健康问题。本研究的目的是为如何识别和治疗原发性卵巢功能不全提供一个广阔的视角。临床症状、激素水平和卵巢造影在诊断原发性卵巢功能不全中都起着重要作用。遗传易感性、自身免疫性疾病和医疗干预都是可能的起源。只有及时做出正确诊断,才能为患病妇女提供咨询和治疗技术。激素替代疗法(HRT)可减轻症状,避免骨质疏松症和心血管疾病等长期后果,并可保留生育能力,这些都是绝经后烦躁症(POI)治疗方法的一部分。为了减轻更年期症状的严重程度并保护骨骼健康,需要进行雌激素替代治疗。雌激素替代疗法的选择应根据患者的具体情况而定,并考虑到年龄、并发症和个人偏好等因素。如果一名年轻女性被诊断出患有 POI,并且她希望将来有孩子,那么她和她的医生就应该讨论生育力保存策略,如卵母细胞或卵巢组织冷冻保存。本概述还将讨论 POI 治疗的最新疗法和可能的革命性方法。干细胞疗法、卵巢组织移植和激素操作都是未经证实的方法。虽然这些疗法仍处于起步阶段,但它们为 POI 治疗的未来带来了希望。总之,这篇综述文章对如何诊断和治疗原发性卵巢功能不全进行了全面、最新的解释。文章强调了对患病女性的早期检测、适当咨询和个性化治疗方案。随着对原发性卵巢功能不全产生过程的深入了解和更有效药物的开发,这些患者的生殖和整体健康状况可能会得到改善。
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引用次数: 0
Assess the usage pattern of menstrual cups and its determinants among young health professionals at a tertiary hospital in Puducherry 评估普杜切里一家三级医院的年轻医务人员使用月经杯的模式及其决定因素
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.076
Porkodi Rabindran, Tamilarasi S, Kanimozhi K, H. T. Lalthanthuami
: Menstrual cups are a better alternative for menstrual hygiene but usage among girls and women is limited due to lack of popularity.  The purpose of this study is to assess the usage of menstrual cup and its determinants among young women in health profession.: This is a cross-sectional analytical study designed to collect data among 370 young women who fulfilled the selection criteria using a cluster sampling method. The objectives of the study were assessed with a self-administered questionnaire. The data were analyzed using descriptive (frequency, percentage, mean, and standard deviation) and inferential statistics (chi-square). All statistical analysis was carried out at a 5% level of significance.: Among 370 young women only 29 (7.8%) use a menstrual cup, nearly 90% of them use it because it is comfortable, non-allergic, convenient during travel, and enables free movement. Only 8 (2.2%) have used it earlier but not presently, about 75% of them stopped because of difficulty in insertion. While 333 (90%) of young women have never used a menstrual cup, about 70% presumed menstrual cup insertion would be difficult and uncomfortable. : Young women despite being in the health profession and knowing about menstrual cups do not use them. This highlights the need for efforts to promote awareness regarding the availability and utilization of menstrual cups to empower girls and women in maintaining menstrual hygiene.
:月经杯是经期卫生的较佳替代品,但由于缺乏普及性,女孩和妇女的使用率有限。 本研究的目的是评估卫生专业年轻女性使用月经杯的情况及其决定因素:这是一项横断面分析研究,旨在通过聚类抽样法收集符合选择标准的 370 名年轻女性的数据。研究目标通过自填问卷进行评估。数据采用描述性统计(频率、百分比、平均值和标准偏差)和推论性统计(卡方)进行分析。所有统计分析均以 5%的显著性水平进行:在 370 名年轻女性中,只有 29 人(7.8%)使用月经杯,其中近 90%的人使用月经杯的原因是月经杯舒适、不过敏、方便旅行和自由活动。只有 8 人(2.2%)以前使用过月经杯,但现在不用了,其中约 75% 的人因插入困难而停止使用。333(90%)名年轻妇女从未使用过月经杯,约 70%的人认为插入月经杯会很困难和不舒服。 尽管年轻妇女从事保健行业并了解月经杯,但她们并不使用月经杯。这突出表明,有必要努力提高人们对月经杯的可用性和使用的认识,以增强女孩和妇女保持经期卫生的能力。
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引用次数: 0
Observational study of usage of a combination of inositols with alpha-lactalbumin (Ovamystic) in the treatment of menstrual irregularity in PCOS 肌醇与α-乳清蛋白复方制剂(Ovamystic)用于治疗多囊卵巢综合征患者月经不调的观察性研究
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.092
Manish R Pandya, Nehal Manish Pandya, Varsha Narayanan, Kishan S Adroja, Vaishvi C Patel
This observational study aimed at evaluating the effects of Ovamystic in groups of women with menstrual irregularities in Polycystic Ovary Syndrome (PCOS), treated at Mahavir Hospital and Manish IVF Center Surendranagar, Gujarat. : The study involved 126 normal weight or overweight PCOS patients aged 18 to 30 years, with menstrual irregularity and anovulation > 12 months. Patients were administered orally chewable tablets of Ovamystic (myo-inositol 1100mg + D-chiro-inositol 27.6mg + alpha-lactalbumin 50mg + chromium picolinate 400mcg + vitamin D2 400IU) twice daily for 6 months. The primary outcome was measured in terms of certain parameters like changes in body mass index (BMI), change in ovarian volume, and change in frequency and duration of menstrual cycle (M-SCORE). Alpha-lactalbumin is effective in increasing myo-inositol intestinal absorption, which is very useful in reducing the therapeutic failure of myo-inositol in some patients (inositol resistant subjects).: Recovery was general, and its relevance was higher when the starting point was further away from the normal range. The most important results with Ovamystic were obtained in correcting the menstrual irregularity, and also decreasing ovarian volume and BMI. No significant adverse effects were detected in this group of patients, and Ovamystic had good tolerability and compliance. This observational study demonstrated that Ovamystic improves important parameters in PCOS patients characterized by different metabolic profiles like BMI, menstrual irregularities, and ovarian volume.
这项观察性研究旨在评估 Ovamystic 对古吉拉特邦 Surendranagar 市 Mahavir 医院和 Manish 试管婴儿中心治疗的多囊卵巢综合症(PCOS)月经不调妇女群体的影响。 研究对象包括 126 名体重正常或超重的多囊卵巢综合症患者,年龄在 18 至 30 岁之间,月经不调和无排卵超过 12 个月。患者口服 Ovamystic 咀嚼片(肌醇 1100 毫克 + D-螺肌醇 27.6 毫克 + α-乳白蛋白 50 毫克 + 吡啶甲酸铬 400 微克 + 维生素 D2 400IU ),每天两次,连续服用 6 个月。主要结果根据某些参数来衡量,如体重指数(BMI)的变化、卵巢体积的变化以及月经周期频率和持续时间(M-SCORE)的变化。α-乳清蛋白能有效增加肌醇的肠道吸收,这对减少肌醇在某些患者(肌醇耐受受试者)中的治疗失败非常有用:恢复是普遍的,当起始点远离正常范围时,恢复的相关性更高。使用 Ovamystic 最重要的结果是纠正了月经不调,还减少了卵巢体积和体重指数。这组患者没有发现明显的不良反应,对 Ovamystic 的耐受性和依从性良好。这项观察性研究表明,Ovamystic 可改善多囊卵巢综合症患者的重要指标,如体重指数、月经不调和卵巢体积等不同的代谢特征。
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引用次数: 0
Knowledge and practice on menstrual hygiene among girl students of Balika Vidya Mandir School, Digboi, Tinsukia, Assam 阿萨姆邦廷苏吉亚迪格博伊 Balika Vidya Mandir 学校女学生的经期卫生知识和做法
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.079
Aparajita Phukan Baruah
: Effective menstrual hygiene is vital to the health, wellbeing, dignity, empowerment, mobility and productivity of girls and women. The inadequate knowledge and improper practice of menstrual hygiene among various age group of girls and women may affect their reproductive health.A descriptive study was carried out with the objectives to assess the knowledge and practice on menstrual hygiene and to assess the significant association between selected Demographic variables with knowledge and practice among the girl students of Balika Vidya Mandir School, Digboi, Tinsukia, Assam. The study was conducted in Balika Vidya Mandir School, Digboi, Tinsukia, Assam, among 60 girl students selected by simple random sampling technique. A self structured questionnaire and a checklist was used to assess the knowledge and practice on menstrual hygiene. Both descriptive and inferential statistics were used to find out the result of the study.Findings related to knowledge revealed that majority 82% (49) girl students had moderately adequate knowledge, 10% (6) had inadequate knowledge and only 8% (5) had adequate knowledge on menstrual hygiene.Findings related to practice revealed that majority 75% (45) girl students had moderately adequate practice, 17% (10) had inadequate practice and only 8% (5) had adequate practice on menstrual hygiene. Findings related to association between knowledge and selected demographic variables revealed that there is significant association between knowledge and age of girl students and family income. Findings related to association between knowledge and selected demographic variables revealed that there is significant association between practice and family income and religion. From the study findings it can be inferred that knowledge and practice of girl students of the school have moderately adequate. Therefore more emphasis should be given on providing knowledge regarding menstrual hygiene among the girl students.
:有效的经期卫生对女童和妇女的健康、福祉、尊严、赋权、流动性和生产力至关重要。我们开展了一项描述性研究,目的是评估经期卫生知识和做法,并评估阿萨姆邦廷苏吉亚迪格博伊 Balika Vidya Mandir 学校女生的某些人口统计学变量与经期卫生知识和做法之间的显著关联。研究在阿萨姆邦廷苏吉亚迪格博伊的巴利卡-维迪娅-曼迪尔学校(Balika Vidya Mandir School)进行,通过简单随机抽样技术选取了 60 名女学生。采用自我结构化问卷和核对表来评估月经卫生知识和做法。与知识相关的调查结果显示,大多数 82%(49 名)的女学生对月经卫生有适度的了解,10%(6 名)的女学生对月经卫生了解不足,只有 8% (5 名)的女学生对月经卫生了解充分。与实践相关的调查结果显示,大多数 75%(45 名)的女学生对月经卫生有适度的实践,17%(10 名)的女学生对月经卫生实践不足,只有 8% (5 名)的女学生对月经卫生实践充分。有关知识与选定人口变量之间关系的研究结果表明,知识与女学生的年龄和家庭收入之间有显 著关系。有关知识与选定人口变量之间关系的研究结果表明,经期卫生习惯与家庭收入和宗教信仰有显 著关系。从研究结果中可以推断出,该校女生的知识和实践适中。因此,应更加重视向女学生提供有关经期卫生的知识。
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引用次数: 0
Role of extended first trimester screening (EFTS) in screening of aneuploidy and prediction of pre-eclampsia 延长孕期筛查(EFTS)在筛查非整倍体和预测先兆子痫中的作用
Pub Date : 2023-11-15 DOI: 10.18231/j.ijogr.2023.085
Anima Anjani, Gunjan Rai, Gargi Vikas Sharma, Shivani Rajouraya, Sunil Kumar Chaudhary
: To assess the role of extended first trimester screening (EFTS) in early detection and management of preeclampsia.: A total of 501 parturients (aged 18-49 years; GA 11-13 weeks) underwent ETFS quadruple test that included age, sonographic data (CRL, Nuchal Tube (NT), ductus venosus PI) and biochemical tests (b-hCG, Alpha-fetoprotein, PLGF and PAPP-A for Trisomy 21, 18 and 13) levels. All the women were followed up for preeclampsia. Role of independent as well as combined ETFS predictors was assessed for prediction of preeclampsia employing independent samples ‘t’- and Fisher exact tests. ROC analysis was performed for continuous predictors significantly associated with preeclampsia risk. Results have been depicted in terms of sensitivity, specificity, positive and negative predictive values of different ETFS risk predictors.Meanage of women was 28.07±4.77 years. Quadruple test was negative in 422 (84.2%). It was positive for Down’s syndrome/T21 in 23 (4.6%), T21 with increased PLGF in 8 (1.6%) and increased PLGF only in 48 (9.6%) cases. A total of 14 (2.8%) women developed preeclampsia. Older age, T21 risk, PLGF risk and any quadruple test abnormality were significantly associated with preeclampsia (p<0.05). On ROC analysis, the area under the curve value of age for prediction of preeclampsia was 0.940. Among different EFTS risks, age had maximum sensitivity (100%) and specificity (88.3%). Overall quadruple test was 71.4% sensitive and 85.8% specific in prediction of preeclampsia.: EFTS was a useful strategy for reducing the burden of preeclampsia.
:目的:评估延长孕期筛查(EFTS)在早期发现和管理子痫前期中的作用。 方法:对 501 名产妇(年龄在 18-49 岁之间;孕期 11-13 周)进行 ETFS 四项检查,包括年龄、超声波数据(CRL、颈管(NT)、静脉导管 PI)和生化检查(b-hCG、甲胎蛋白、PLGF 和 PAPP-A,以检测 21、18 和 13 三体综合征)水平。所有妇女都接受了子痫前期随访。通过独立样本 "t "检验和费舍尔精确检验,评估了独立和综合 ETFS 预测因子在预测子痫前期方面的作用。对与子痫前期风险显著相关的连续预测因子进行了 ROC 分析。结果显示了不同 ETFS 风险预测指标的敏感性、特异性、阳性和阴性预测值。422人(84.2%)的四项检测结果为阴性。23例(4.6%)唐氏综合征/T21阳性,8例(1.6%)T21和PLGF增高阳性,48例(9.6%)仅PLGF增高阳性。共有 14 名(2.8%)妇女出现子痫前期。高龄、T21 风险、PLGF 风险和任何四项检测异常都与子痫前期显著相关(P<0.05)。根据 ROC 分析,年龄预测子痫前期的曲线下面积值为 0.940。在不同的 EFTS 风险中,年龄的灵敏度(100%)和特异性(88.3%)最高。总体而言,四重检测对子痫前期预测的敏感度为 71.4%,特异度为 85.8%。
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Indian Journal of Obstetrics and Gynecology Research
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