Working... Menu

Development of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022814
Recruitment Status : Unknown
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2009
Last Update Posted : December 1, 2009
Information provided by:
Hadassah Medical Organization

Brief Summary:
In the final months of pregnancy, women need to know whether their 'water is broken' necessitating a race to the delivery room, or whether pressure of the foetus on their bladder has caused them merely to pass urine. They may also have faced the same dilemma on many occasions much earlier in the pregnancy. With this development the investigators will provide them with an immediate answer to this critical question.

Condition or disease Intervention/treatment
Color Reaction With Amniotic Fluid Device: A disposable pad containing sensitive chemical indicators

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Pregnant woman Device: A disposable pad containing sensitive chemical indicators
After a urine/amniotic fluid leaking, liquid meets the diagnostic device and chemical reactions will occur in the test zones and cause a color change.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
An unrecognized amniotic fluid that passed a genetic analysis and appointed to be disposed.

Inclusion Criteria:

  • Amniotic fluid that were taken after the 17th week.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022814

Layout table for location contacts
Contact: Nili Yanai, Dr' 050-7874559

Layout table for location information
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Principal Investigator: Nili Yanai, Dr'         
Sponsors and Collaborators
Hadassah Medical Organization
Layout table for investigator information
Principal Investigator: Nili Yanai, Dr' Hadassah Medical Organization

Layout table for additonal information
Responsible Party: Arik Tzukert, Hadassah Medical Organization Identifier: NCT01022814     History of Changes
Other Study ID Numbers: Momteclife-HMO-CTIL
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009