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Clinical Trials/NCT02339623
NCT02339623UnknownNot Applicable

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

Ain Shams Maternity Hospital1 site in 1 country78 target enrollmentStarted: August 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
78
Locations
1
Primary Endpoint
Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 .
  • 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%
  • 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 .

Outcomes

Primary Outcomes

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

Time Frame: within 7 days of ultrasound scan

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.

Secondary Outcomes

  • accurecy of measuring cervical length in prediction of impending preterm birth(7 days of ultrasound scan)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rania Ahmed Mohammed Rizk

Ob & Gyn Visitor Resident

Ain Shams Maternity Hospital

Study Sites (1)

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