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Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?

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ClinicalTrials.gov Identifier: NCT00720252
Recruitment Status : Terminated (TECHNICAL ISSUES)
First Posted : July 22, 2008
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment Phase
Fetal Lung Maturity Device: Ultrasound Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
Study Start Date : July 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Device: Ultrasound
To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720252


Locations
Israel
Dep. OB/GYN, HaEmek Medical Center
Afula, Israel, 18100
Sponsors and Collaborators
HaEmek Medical Center, Israel