NCT02351336

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

January 22, 2015

Last Update Submit

February 15, 2015

Conditions

Preterm Labour

Keywords

Threatened preterm birthFetal adrenal gland volumeFetal zone enlargementPrediction of preterm birth

Outcome Measures

Primary Outcomes (1)

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

    within 7 days of ultrasound scan

Secondary Outcomes (1)

  • Superiority of Adrenal gland volme estimation in prediction of preterm birth compared to cervical length measurement alone

    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 imagingDEVICE

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)

threatened preterm labour

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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:

  • 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 .
  • 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 .
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 21292230BACKGROUND

Related Links

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Wessam M Abouelghar, MD

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

Central Study Contacts

Wessam M Abouelghar, MD

CONTACT

002-01227460679dr.awessam@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assisstant Professor of Obstetrics & Gynecology

Study Record Dates

First Submitted

January 22, 2015

First Posted

January 30, 2015

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

EG(1)