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Trial record 2 of 3297 for:    preterm birth

Fetal Adrenal Gland Volume Estimation in Prediction of Preterm Birth

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Ain Shams Maternity Hospital
Sponsor:
Information provided by (Responsible Party):
Rania Ahmed Mohammed Rizk, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT02339623
First received: January 13, 2015
Last updated: NA
Last verified: January 2015
History: No changes posted
  Purpose
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.

Condition Intervention
Preterm Birth
Device: Ultrasound imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Three - Dimensional Ultrasound Estimation of Fetal Adrenal Gland Enlargement Compared to Assessment of Cervical Changes Alone & Prediction of Impending Preterm Birth

Resource links provided by NLM:


Further study details as provided by Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • Accurate prediction of impending preterm birth using 3D ultrasound estimation of fetal adrenal gland volume [ Time Frame: within 7 days of ultrasound scan ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • accurecy of measuring cervical length in prediction of impending preterm birth [ Time Frame: 7 days of ultrasound scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: August 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
threatened preterm labour

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%
Device: Ultrasound 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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%
Criteria

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 .

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02339623

Contacts
Contact: Rania A Rizk, M.B, B.Ch 002-01222799057 dr_rania.rizk@yahoo.com
Contact: Wessam M Abouelghar, MD 002-01227460679 dr.awessam@gmail.com

Locations
Egypt
Ain Shams Maternity Hospital Recruiting
Cairo, Egypt
Contact: Wessam M Abouelghar, MD    002-01227460679    dr.awessam@gmail.com   
Principal Investigator: Rania A Rizk, M.B, B.Ch         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Study Chair: Wessam Ma Abouelghar, MD Ain Shams Maternity Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Rania Ahmed Mohammed Rizk, Ob & Gyn Visitor Resident, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02339623     History of Changes
Other Study ID Numbers: ACTG 021 
Study First Received: January 13, 2015
Last Updated: January 13, 2015
Health Authority: Egypt :Ain Shams Maternity Hospital

Keywords provided by Ain Shams Maternity Hospital:
Threatened preterm birth - fetal adrenal gland volume

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 26, 2016