Detection of Meconium in Amniotic Fluid in Post Term Pregnancies
Meconium constitutes the bowel contents of the fetus and is normally expelled only after birth. However, it may be secreted into the amniotic fluid of 20% of all fetuses. Meconium Stained Amniotic Fluid had been recognized from ancient times as an obstetric hazard which complicates delivery and is associated with increased newborn morbidity and mortality. At present there is no viable diagnostic test for Meconium prior to the onset of labor and the rupture of membranes. The system developed for the detection of Meconium, based on recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light excitation at a specific wavelength. The diagnostic test being developed does not require penetration into the amniotic sac and is safe, painless and simple to perform.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Detection of Meconium in Amniotic Fluid in Post Term Pregnancies|
- Determine the capability for diagnosing Meconium stained Amniotic Fluid prior to a cervical ripening procedure in women, using the Amniometer device [ Time Frame: prior to breakage of water ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Other: amniometer model po1
The detection of Meconium, is based on recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light excitation at a specific wavelength.
The diagnostic test does not require penetration into the amniotic sac and is safe, painless and simple to perform.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429974
|Contact: Arie Orenstein, professor||972-3-5303114||Arie.Orenstein@sheba.health.gov.il|
|Sheba Medical Center||Recruiting|
|Ramat gan, Israel|
|Contact: Genady Kostenich, Ph.D 972-3-5303114 Genady.Kostenich@sheba.health.gov.il|
|Principal Investigator: Arie Orenstein, Prof|
|Sub-Investigator: Reuven Ahiron, prof|
|Sub-Investigator: Yoav Inon, Dr|
|Sub-Investigator: Anat Kalter-Farber, Dr|
|Sub-Investigator: Orit Moran, Dr|
|Sub-Investigator: Genady Kostenich, Ph.D|
|Sub-Investigator: Kis Salem, MD|
|Principal Investigator:||Arie Orenstein, professor||Sheba Medical Center|