Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

Meconium Clinical Trial

Official title:

Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01429974
• Other study ID #: SHEBA-11-8479-AO-CTIL
• Status: Terminated
• Phase: N/A
• First received: September 6, 2011
• Last updated: May 24, 2017
• Start date: September 2011
• Est. completion date: July 7, 2015

Study information

• Verified date: May 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: July 7, 2015
• Est. primary completion date: July 7, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 37-42 weeks regnancy without rupture of membranes

Exclusion Criteria:

Related Conditions & MeSH terms

• Meconium
• Pregnancy, Prolonged

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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