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Fetal Adrenal Gland Volume Estimation 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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02339623
Enrollment
78
Registered
2015-01-15
Start date
2014-08-31
Completion date
2015-02-28
Last updated
2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Threatened preterm birth - fetal adrenal gland volume

Brief summary

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.

Detailed description

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.

Interventions

DEVICEUltrasound imaging

1. \- Fetal adrenal gland volume calculation using 3D ultrasound 2. \- Assessment of the fetal central adrenal zone enlargement by 3D ultrasound 3. \- CL measurement using 2D ultrasound

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

\- 1. Age : 18 - 40 years 2. Gestational age : 26 - 35 weeks , which is going to be calculated according to the date of last menstrual period & confirmed by first trimester ultrasonography . 3 - 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% 4. 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 .

Exclusion criteria

* 1 - Suspected fetal growth restriction . 2- Preterm premature rupture of the membranes : confirmed by visualization of amniotic fluid vaginal pooling at the time of sterile speculum examination . 3- Patients with antepartum haemorrhage ( due to placental abruption &/or placenta previa ) . 4 - Presence of fetal anomalies incompatible with life. 5 - Patients who are not sure of dates .

Design outcomes

Primary

MeasureTime frameDescription
Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volumewithin 7 days of ultrasound scanIf 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.

Secondary

MeasureTime frame
accurecy of measuring cervical length in prediction of impending preterm birth7 days of ultrasound scan

Countries

Egypt

Contacts

Primary ContactRania A Rizk, M.B, B.Ch
dr_rania.rizk@yahoo.com002-01222799057
Backup ContactWessam M Abouelghar, MD
dr.awessam@gmail.com002-01227460679

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026