Can Ultrasound Replace Amniocentesis for Confirming Fetal... | NCT00720252

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

NCT00720252

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Mar 24, 2015Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Fetal Lung Maturity

Interventions

Ultrasound

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

TECHNICAL ISSUES

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 19, 2008

First Submission Date that Met QC Criteria

Jul 19, 2008

First Posted Date

Jul 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Device: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device	To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep. OB/GYN, HaEmek Medical Center		Afula		18100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6368667	Background	Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. No abstract available.
9168577	Background	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.

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis