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

This study has been terminated.
(TECHNICAL ISSUES)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720252
First Posted: July 22, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
  Purpose
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 Intervention
Fetal Lung Maturity Device: Ultrasound

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Raed Salim, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Ultrasound
To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00720252     History of Changes
Other Study ID Numbers: 0029-08-EMC
First Submitted: July 19, 2008
First Posted: July 22, 2008
Last Update Posted: March 24, 2015
Last Verified: March 2015