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TerminatedNCT00720252Updated Mar 24, 2015

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

An interventional study of Ultrasound in Fetal Lung Maturity, sponsored by HaEmek Medical Center, Israel. Terminated at 1 site in Israel. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Diagnostic

Why this study was terminated
TECHNICAL ISSUES
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 48 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Fetal Lung Maturity
03

In context

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women delivering between 27 to 37 weeks.
  • Women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks.

Exclusion criteria

Exclusion Criteria:

  • Major fetal malformation.
  • Oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    A

    Device: Ultrasound

Interventions

  • DeviceUltrasound

    To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Dep. OB/GYN, HaEmek Medical Center
    Afula, 18100, Israel
08

References and documents

Publications

  • Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. No abstract available. PubMed 6368667 ↗
  • 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. PubMed 9168577 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00720252
Lead sponsor
HaEmek Medical Center, Israel
Responsible party
Raed Salim (MD, HaEmek Medical Center, Israel) — Principal investigator
First posted
Jul 22, 2008
Start date
Jul 2008
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 24, 2015
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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