NCT01735695

Brief Summary

The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

November 25, 2012

Last Update Submit

April 28, 2013

Conditions

Pregnancy

Keywords

Meconiumconcentrationlevel

Outcome Measures

Primary Outcomes (1)

  • Meconium concentration in amniotic fluid

    One year

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women

You may qualify if:

  • Provide written or oral informed consent to participate in the study and agree to comply with study procedures.
  • Pregnant.
  • Intend to seek medical care during pregnancy.

You may not qualify if:

  • Amniotic fluid samples are mixed with urine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laniado Hospital

Netanya, Israel

RECRUITING

Study Officials

  • Brigita Wintrov, MD

    Laniado Medical Center

    STUDY DIRECTOR

Central Study Contacts

Brigita Weitrov, MD

CONTACT

972-50-8840757morami12@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 25, 2012

First Posted

November 28, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

IL(1)