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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01022814
Other study ID # Momteclife-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 26, 2009
Last updated November 30, 2009
Start date January 2010

Study information

Verified date November 2009
Source Hadassah Medical Organization
Contact Nili Yanai, Dr'
Phone 050-7874559
Email yanaio@netvision.net.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Color Reaction With Amniotic Fluid

Intervention

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.

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,