NCT01429974

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2015

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

September 6, 2011

Last Update Submit

May 24, 2017

Conditions

Meconium

Keywords

amniotic fluidpost term pregnancies

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

volunteers

Other: amniometer model po1

Interventions

amniometer model po1OTHER

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.

volunteers

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post term pregnant females

You may qualify if:

  • weeks regnancy without rupture of membranes

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Study Officials

  • Arie Orenstein, professor

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 7, 2011

Study Start

September 1, 2011

Primary Completion

July 7, 2015

Study Completion

July 7, 2015

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

IL(1)