NCT02351336

Fetal Adrenal Gland Volume Estimation Compared to Cervical Length Assessment in Prediction of Preterm Birth

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 78 (estimated)
• Sponsor: Wessam Magdy Abouelghar · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Preterm Labour

Interventions

Type	Name	Description
DEVICE	Ultrasound imaging	1. \- Fetal adrenal gland volume calculation using 3D ultrasound ( in mm3) 2. \- corrected adrenal gland volume calculation ( adrenal gland volume (mm3)/ estimated fetal weight (kg) ) 3. \- CL measurement using 2D ultrasound ( in cm)

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2015-01-30
• Last updated: 2015-02-18

Locations

1 site across 1 country: Egypt