Preterm Birth Clinical Trial
Official title:
Three - Dimensional Ultrasound Estimation of Fetal Adrenal Gland Enlargement Compared to Assessment of Cervical Changes Alone & Prediction of Impending Preterm Birth
If we 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 , we 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.
Preterm birth ( PTB) is one of the leading causes of neonatal morbidity and mortality
(Goldenberg et al., 2008) 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.
(Honest et al., 2009)
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.
(Ozhan et al., 2007) 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. (Rengaraj et al.,
2009) 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. ( Crane et al.,
1997) 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. (Norwitz et al, 1999) A previous study
demonstrated that three -dimensional ultrasound measurement of fetal adrenal gland volume
(AGV) may identify women at risk for impending PTB. (Turan et al, 2007) 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. (Turan et al, 2012)
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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