Fetal Adrenal Gland Volume Estimation in Prediction of Preterm Birth

NCT02339623 | Unknown DMC

• 1 other identifier: ACTG 021
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Threatened preterm birth - fetal adrenal gland volume

Outcome Measures

Primary Outcomes (1)

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

  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.

  within 7 days of ultrasound scan

Secondary Outcomes (1)

• accurecy of measuring cervical length in prediction of impending preterm birth

  7 days of ultrasound scan

Study Arms (1)

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

Interventions

Ultrasound imaging DEVICE

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

threatened preterm labour

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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%

You may qualify if:

• \- 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 .
• 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 .

You may not qualify if:

• 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 .
• Patients with antepartum haemorrhage ( due to placental abruption \&/or placenta previa ) .
• Presence of fetal anomalies incompatible with life. 5 - Patients who are not sure of dates .

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

RECRUITING

Related Publications (1)

• Turan OM, Turan S, Funai EF, Buhimschi IA, Campbell CH, Bahtiyar OM, Harman CR, Copel JA, Buhimschi CS, Baschat AA. Ultrasound measurement of fetal adrenal gland enlargement: an accurate predictor of preterm birth. Am J Obstet Gynecol. 2011 Apr;204(4):311.e1-10. doi: 10.1016/j.ajog.2010.11.034. Epub 2011 Feb 3.

  PMID: 21292230 BACKGROUND

Related Links

• Ultrasound measurement of fetal adrenal gland enlargement: an accurate predictor of preterm birth.

MeSH Terms

Conditions

Premature Birth

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wessam Ma Abouelghar, MD

  Ain Shams Maternity Hospital

  STUDY CHAIR

Central Study Contacts

Rania A Rizk, M.B, B.Ch

CONTACT

002-01222799057; dr_rania.rizk@yahoo.com

Wessam M Abouelghar, MD

CONTACT

002-01227460679; dr.awessam@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ob & Gyn Visitor Resident

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 15, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

EG (1)