Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

Terminated

• Conditions: Meconium
• Interventions: Other: amniometer model po1

• Registration Number: NCT01429974
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2015-07-07
• Study Completion: 2015-07-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

• 37-42 weeks regnancy without rupture of membranes

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
volunteers	amniometer model po1	-

Primary Outcome Measures

Name	Time	Method
Determine the capability for diagnosing Meconium stained Amniotic Fluid prior to a cervical ripening procedure in women, using the Amniometer device	prior to breakage of water

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat gan, Israel