定性宫颈阴道胎儿纤维连接蛋白试验预测有症状孕妇自发性早产的准确性

E. Alajiki, O. Fasubaa, E. Babalola, M. Ajayi, A. Sule, C. Umelo, A. Magaji, E. Orji, K. Ajenifuja
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引用次数: 0

摘要

背景:早产的发病率在世界范围内呈上升趋势。早产是新生儿发病和死亡的常见原因,通常与新生儿低出生体重和肺表面活性剂缺乏有关。与足月出生的儿童相比,早产儿童患脑瘫、神经发育异常、学习障碍和呼吸系统疾病的比例更高,并给父母或照顾者带来随之而来的社会心理和经济负担。这些问题可以通过使用早产预测测试来最小化,如母体宫颈阴道胎儿纤维连接蛋白测试(FFT),以确定哪些妇女是真正的早产,哪些妇女有较高的早产风险。然后可以针对这组妇女进行有效的治疗,以减少早产的发生率。然而,FFT在早产预测中的应用在尼日利亚尚未得到充分利用。目的:确定宫颈阴道胎儿纤维连接蛋白检测在有症状的孕妇自发性早产的预测作用。环境:本研究在尼日利亚奥孙州Ile-Ife的Obafemi Awolowo大学教学医院(OAUTHC)的妇产科进行。OAUTHC包括两个产科单位——Ife医院单位(IHU)和Ilesha卫斯理公会医院单位(WGH)。设计:横断面描述性研究。方法:本研究招募了182名妊娠28周至36周6天有早产症状的单胎母亲。每位受试者填写一份问卷,然后使用无菌棉签进行无菌阴道镜检查,以获取受试者宫颈阴道分泌物标本。对收集的每个样本进行定性FFT,然后对招募的母亲进行监测,直到分娩并获得进一步的数据。结局指标:主要结局指标为FFT预测有症状孕妇自发性早产的敏感性、特异性、阴性预测值(NPV)和阳性预测值(PPV)。结果:共招募了182名出现早产症状的妇女:171名(93.96%)足月分娩的妇女,而11名(6.04%)妇女早产,在研究期间计算的早产率为7.33 / 1000分娩。FFT阳性7例(3.85%),阴性175例(96.15%)。FFT的敏感性、特异性、PPV和NPV分别为9.09%、96.49%、14.29%和94.29%;LR+和LR-分别为2.59(95%可信区间,CI, 0.34-19.68)和0.94 (95% CI, 0.78-1.14);相对危险度为2.59 (95% CI, 0.341-19.675);计算准确率为91.21% (95% CI, 86.12%-94.89%);接收机工作特性曲线下面积为0.60。结论:在有症状的孕妇人群中,胎儿纤维连接蛋白取样的高净现值支持对阴性结果的患者较少干预。
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Accuracy of qualitative maternal cervicovaginal fetal fibronectin test in predicting spontaneous preterm birth in symptomatic pregnant women
Background: The incidence of preterm birth is increasing worldwide. Preterm birth is a common cause of neonatal morbidity and mortality commonly associated with low-birth weight and deficiency of lung surfactants in the newborn. Children who were born preterm have higher rates of cerebral palsy, neurodevelopmental anomalies, learning disabilities, and respiratory illnesses compared with children born at term with attendant psychosocial and financial burden on the parents or carers. These problems may be minimized via the use of a preterm birth prediction test such as the maternal cervicovaginal fetal fibronectin test (FFT) to determine those women in genuine preterm labor and at a higher risk for preterm birth. Effective treatment can then be focused on this group of women to reduce the incidence of preterm birth. However, the FFT in preterm birth prediction is underutilized in Nigeria. Aim: To determine the role of cervicovaginal fetal fibronectin testing as a predictor of spontaneous preterm birth in symptomatic pregnant women in a local setting. Setting: This study was conducted at the obstetrics unit of the Department of Obstetrics and Gynaecology at the Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Osun state, Nigeria. The OAUTHC comprises two obstetrics units – Ife Hospital Unit (IHU) and Wesley Guild Hospital Unit at Ilesha (WGH). Design: Cross-sectional, descriptive study. Methods: In this study, 182 booked and unbooked singleton antenatal mothers between 28 weeks and 36 weeks 6 days gestation who had symptoms suggestive of preterm labor were recruited. An interviewer administered questionnaire was filled for each subject and a sterile speculum vaginal examination was then performed to obtain a specimen of the subject's cervicovaginal secretion using a sterile cotton swab. A qualitative FFT was done on each sample collected, then recruited mothers were monitored till delivery and further data obtained. Outcome Measures: The main outcome measures were the sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of FFT in predicting spontaneous preterm birth in symptomatic pregnant women. Results: A total of 182 women presenting with symptoms suggestive of preterm labor were recruited: 171 (93.96%) women delivered at term, whereas 11 (6.04%) women had preterm birth with a calculated preterm birth rate of 7.33 per 1000 deliveries during the study period. Also, 7 (3.85%) women had a positive FFT, while 175 (96.15%) women had a negative test. FFT had a sensitivity, specificity, PPV, and NPV of 9.09%, 96.49%, 14.29%, and 94.29%, respectively; a LR+ and LR- of 2.59 (95% confidence interval, CI, 0.34–19.68) and 0.94 (95% CI, 0.78–1.14) respectively; a relative risk of 2.59 (95% CI, 0.341–19.675); a calculated accuracy of 91.21% (95% CI, 86.12%–94.89%); and an area under the receiver operating characteristic curve of 0.60. Conclusion: The high NPV of fetal fibronectin sampling in a population of pregnant women with symptoms supports less intervention for patients with negative results.
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