Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01429974
First received: September 6, 2011
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Meconium
Other: amniometer model po1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: September 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
volunteers 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.


  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Post term pregnant females

Criteria

Inclusion Criteria:

  • 37-42 weeks regnancy without rupture of membranes

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429974

Contacts
Contact: Arie Orenstein, professor 972-3-5303114 Arie.Orenstein@sheba.health.gov.il

Locations
Israel
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         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arie Orenstein, professor Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01429974     History of Changes
Other Study ID Numbers: SHEBA-11-8479-AO-CTIL
Study First Received: September 6, 2011
Last Updated: January 23, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
amniotic fluid
post term pregnancies

Additional relevant MeSH terms:
Pregnancy, Prolonged
Pregnancy Complications

ClinicalTrials.gov processed this record on August 26, 2014