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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014