Detection of Meconium in Amniotic Fluid in Post Term Pregnancies

NCT ID: NCT01429974

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-07-07

Brief Summary

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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

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Conditions

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Meconium

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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volunteers

amniometer model po1

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 37-42 weeks regnancy without rupture of membranes

Exclusion Criteria

* none
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arie Orenstein, professor

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-11-8479-AO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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