Back to resultsCan Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
Primary Purpose
Fetal Lung Maturity
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Fetal Lung Maturity
Eligibility Criteria
Inclusion Criteria:
- Women delivering between 27 to 37 weeks.
- Women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks.
Exclusion Criteria:
- Major fetal malformation.
- Oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.
Sites / Locations
- Dep. OB/GYN, HaEmek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
To check whether a threshold exists between peak velocity and/or volume of fluid inspired by the fetus and lung maturation.
Secondary Outcome Measures
Full Information
NCT ID
NCT00720252
First Posted
July 19, 2008
Last Updated
March 20, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00720252
Brief Title
Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
Official Title
Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
TECHNICAL ISSUES
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to measure prenatally with ultrasound the intratracheal flow volume displaced during breathing cycle in premature fetuses and to check whether a relationship exists between the inspired fluid and fetal lung maturation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Lung Maturity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.
Primary Outcome Measure Information:
Title
To check whether a threshold exists between peak velocity and/or volume of fluid inspired by the fetus and lung maturation.
Time Frame
end of the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women delivering between 27 to 37 weeks.
Women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks.
Exclusion Criteria:
Major fetal malformation.
Oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.
Facility Information:
Facility Name
Dep. OB/GYN, HaEmek Medical Center
City
Afula
ZIP/Postal Code
18100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
6368667
Citation
Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. No abstract available.
Results Reference
background
PubMed Identifier
9168577
Citation
Kalache KD, Chaoui R, Bollmann R. Doppler assessment of tracheal and nasal fluid flow during fetal breathing movements: preliminary observations. Ultrasound Obstet Gynecol. 1997 Apr;9(4):257-61. doi: 10.1046/j.1469-0705.1997.09040257.x.
Results Reference
background
Learn more about this trial
Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
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