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

NCT ID: NCT01022814

Last Updated: 2009-12-01

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Color Reaction With Amniotic Fluid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant woman

A disposable pad containing sensitive chemical indicators

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Principal Investigators

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Nili Yanai, Dr'

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nili Yanai, Dr'

Role: CONTACT

Phone: 050-7874559

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Other Identifiers

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Momteclife-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id