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

November 30, 2009 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization
        • Principal Investigator:
          • Nili Yanai, Dr'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

An unrecognized amniotic fluid that passed a genetic analysis and appointed to be disposed.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Nili Yanai, Dr', Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2012

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (ESTIMATE)

December 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 30, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • Momteclife-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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