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

NCT ID: NCT00720252

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Lung Maturity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

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

Interventions

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Ultrasound

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Raed Salim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dep. OB/GYN, HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. No abstract available.

Reference Type BACKGROUND
PMID: 6368667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9168577 (View on PubMed)

Other Identifiers

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0029-08-EMC

Identifier Type: -

Identifier Source: org_study_id

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