Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity
研究概览
详细说明
Neonatal respiratory distress syndrome (RDS) remains a major cause of neonatal morbidity and mortality. A recent epidemiologic study in the United States estimates that there are 80,000 cases of neonatal RDS each year, resulting in 8500 deaths and hospital costs in excess of $4.4 billion.
A number of biochemical tests have been developed to predict the risk of RDS and assist obstetric care providers in delivery timing. Amniotic fluid lamellar body count (LBC) is an important biophysical test, based on measuring the concentration of pulmonary surfactant in amniotic fluid. It can be effectively used to assess fetal lung maturity. A noninvasive test for fetal lung maturity (FLM) would be useful to minimize the need for invasive testing and would be more acceptable to women. Fetal pulmonary artery Doppler waveform acceleration/ejection time may provide a noninvasive means of determining fetal lung maturity with relatively acceptable levels of sensitivity, specificity, and predictive values.
The investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal pulmonary artery Doppler will be correlated with fetal outcome.
Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using Mann Whitney U test for independent samples while categorical data will compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:AbdelGany MA Hassan, MRCOG, MD
- 电话号码:+201017801604
- 邮箱:abdelgany2@gmail.com
学习地点
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Cairo、埃及
- 招聘中
- Cairo University Hospitals
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接触:
- AbdelGany Hassan, MRCOG, MD
- 电话号码:002 01017801604
- 邮箱:abdelgany2@gmail.com
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副研究员:
- AbdelGany MA Hassan, MRCOG, MD
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首席研究员:
- Sherif Negm, MD
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副研究员:
- Doaa Salah, MD
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Cairo、埃及
- 招聘中
- Al Galaa maternity fospital
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接触:
- Mohamed Wafeek
- 电话号码:002 01223524286
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首席研究员:
- Mohamed Wafeek
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Singleton pregnancies without any major congenital anomalies.
- Gestation between 32-36 weeks
- Women presenting preterm pre-labour ruptured membranes or undergoing a cesarean section.
Exclusion Criteria:
- Patients with major fetal anomalies.
- Bloody or meconium stained amniotic fluid
- preexisting maternal medical conditions (eg, diabetes, renal disease, hypertensive disorders, vaginal bleeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:preterm labour
200 women with preterm prelabour ruptured membranes or undergoing preterm CS
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The LBC (the unit of measurement is number of lamellar bodies counted per microliter of amniotic fluid) will be determined using the platelet channels on the Hematology Flow Cytometer.
其他名称:
A fetal pulmonary artery Doppler will be performed using color Doppler ultrasound.
Doppler flow velocity measurements, including systolic/diastolic ratio, pulsatility index, resistance index, and acceleration-time/ejection-time ratio using spectral Doppler ultrasound.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Respiratory distress syndrome (RDS)
大体时间:1 day after delivery
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RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.
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1 day after delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Need for incubation
大体时间:1 day after delivery
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It will be recorded if the pediatrician decides to incubate the neonate.
The reason for incubation e.g.
ventilation, hypoxia, ischemia will be recorded.
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1 day after delivery
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合作者和调查者
出版物和有用的链接
一般刊物
- AVERY ME, MEAD J. Surface properties in relation to atelectasis and hyaline membrane disease. AMA J Dis Child. 1959 May;97(5, Part 1):517-23. doi: 10.1001/archpedi.1959.02070010519001. No abstract available.
- Dubin SB. Characterization of amniotic fluid lamellar bodies by resistive-pulse counting: relationship to measures of fetal lung maturity. Clin Chem. 1989 Apr;35(4):612-6.
- Neerhof MG, Dohnal JC, Ashwood ER, Lee IS, Anceschi MM. Lamellar body counts: a consensus on protocol. Obstet Gynecol. 2001 Feb;97(2):318-20. doi: 10.1016/s0029-7844(00)01134-0.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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早产的临床试验
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical Center招聘中早产 | 怀孕早产 | 舞会(怀孕) | 怀孕舞会 | PROM,早产(怀孕) | Premat Rupture Membranes Preterm 未指定破裂/分娩之间的时间长度美国