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临床试验/NCT02351336
NCT02351336Unknown不适用

Three - Dimensional Ultrasound Estimation of Fetal Adrenal Gland Enlargement Compared to Assessment of Cervical Changes Alone & Prediction of Impending Preterm Birth

Wessam Magdy Abouelghar1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
78
试验地点
1
主要终点
1. Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume

研究概览

简要总结

If the investigators could prove that three -dimensional ultrasound measurement of fetal adrenal gland volume can accurately predict the likelihood of preterm birth in patients having symptoms and signs of PTL , they would be able to use it as a valuable component for assessment and early management of high risk pregnant women for PTB which can be positively reflected on the risk of neonatal morbidity and mortality in those patients.

详细描述

Preterm birth ( PTB) is one of the leading causes of neonatal morbidity and mortality Early PTB (≤ 34 weeks' gestation) carries a 7-fold increased risk of Neonatal death . Following PTB, survivors can experience significant long term cognitive, behavioral, emotional, sensory, and motor deficits. Hence, there is growing interest in the identification of women who are at Risk for spontaneous PTB. Many biophysical and biochemical markers have been discovered to identify those women who are at risk for spontaneous PTB.

Unfortunately, none of the various maternal and fetal biomarkers such as:

cytokines, CRH, C-reactive protein, fetal fibronectin ,.... etc. are sufficiently sensitive or specific to be used alone or in combination to help decrease the rate of preterm births. Obviously, there's a need for an accurate method with high sensitivity and specificity for prediction of preterm labor. So that an appropriate management or referral to a higher center can be done to women likely to have PTB. Whereas unnecessary tocolytic therapy can be avoided in women who are unlikely to have PTB. Convincing data have shown that 2-dimensional (2D) ultrasound measurement of cervical length (CL) can identify women at risk for PTB.

Accordingly, CL is now widely used in clinical practice for risk estimation. However, as understanding of the mechanisms of preterm labor (PTL) have evolved, obstetricians have learned that, in some women, cervical shortening is a phenomenon that carries no increased risk for prematurity. Therefore, the search for early and accurate markers that distinguish between physiologic processes and abnormal activation of the labor cascade has been ongoing.

Literature has suggested that activation of the fetal hypothalamic-pituitary-adrenal axis play a crucial rule in commencement of labor. A previous study demonstrated that three -dimensional ultrasound measurement of fetal adrenal gland volume (AGV) may identify women at risk for impending PTB. In a more recent study receiver operator characteristics (ROC) curve analysis revealed that three -dimensional ultrasound measurement of (AGV) was superior to two-dimensional ultrasound measurement of (AGV) for anticipation of PTB within 7 days of the scan. The aim of this study is to investigate the utility of 3D fetal adrenal gland volume measurement in the early prediction of PTB and to determine whether these measurements could be combined with 2D ultrasound cervical assessment to improve the early prediction of PTB.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age : 18 - 40 years
  • Gestational age: 26 - 35 weeks , which is going to be calculated according to the date of last menstrual period & confirmed by first trimester ultrasonography .
  • Women who are diagnosed as having threatened preterm labour based on the American college of obstetricians and gynaecologists guidelines (ACOG,2003) :
  • Presence of uterine contractions ( at least 4 in 20 minutes or 8 in 60 minutes )
  • Cervical dilataion >1cm, &/or
  • Cervical effacement ≥ 80%
  • Women having one or more of the following:
  • Multifetal pregnancy .
  • Previous preterm labor or premature birth, particularly in the most recent pregnancy or in more than one previous pregnancy

排除标准

  • Suspected fetal growth restriction .
  • Preterm premature rupture of the membranes : confirmed by visualization of amniotic fluid vaginal pooling at the time of sterile speculum examination .
  • Patients with antepartum haemorrhage ( due to placental abruption &/or placenta previa )
  • Presence of fetal anomalies incompatible with life. 5 - Patients who are not sure of dates

结局指标

主要结局

1. Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume

时间窗: within 7 days of ultrasound scan

次要结局

  • Superiority of Adrenal gland volme estimation in prediction of preterm birth compared to cervical length measurement alone(7 days of ultrasound scan)

研究者

发起方
Wessam Magdy Abouelghar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wessam Magdy Abouelghar

Assisstant Professor of Obstetrics & Gynecology

Ain Shams Maternity Hospital

研究点 (1)

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