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

This study has suspended participant recruitment.
(TECHNICAL ISSUES)
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00720252
First received: July 19, 2008
Last updated: September 5, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: June 2014
Estimated 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

Ages Eligible for Study:   18 Years to 48 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 19, 2008
Last Updated: September 5, 2012
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on April 15, 2014