Amniotic Fluid Leakage Clinical Trial
Official title:
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Verified date | January 2012 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Pregnant women age 18 years and older attending delivery room. 2. Stage of gestation: pregnancy between 16 and 42 weeks of gestation. 3. Able and willing to read and sign an informed consent document. Exclusion Criteria: Subjects will be excluded from the study if any of the following will be present: 1. Prior use of any amniotic fluid detection test. 2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours. 3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours. 4. Sexual intercourse within the past 24 hours. 5. Confirmed diagnosis of any vaginal infection within the past 7 days. 6. Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days.. 7. Patients unable or unwilling to participate. 8. Patients in active labor (or with regular contractions). |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence / absence of stains comparing to a known color index printed on the product | Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman. | 12 hours | No |
Secondary | Presence / absence of stains comparing to a known color index printed on the product | Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions. | 12 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04963465 -
The Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
|
||
Completed |
NCT04100252 -
The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes
|
||
Completed |
NCT03190434 -
Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage
|
N/A | |
Completed |
NCT00604838 -
Pivotal Study of the Al-Sense Study Protocol
|
Phase 1/Phase 2 |