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

Fetal Lung Maturity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00720252
• Other study ID #: 0029-08-EMC
• Status: Terminated
• Phase: N/A
• First received: July 19, 2008
• Last updated: March 20, 2015
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fetal Lung Maturity

Intervention

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

Locations

Country	Name	City	State
Israel	Dep. OB/GYN, HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To check whether a threshold exists between peak velocity and/or volume of fluid inspired by the fetus and lung maturation.		end of the study	No