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Clinical Trials/NL-OMON46986
NL-OMON46986
Completed
Not Applicable

Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor - PartoSure TTD test (Time To Delivery)

HAGAMEDICAL B.V.0 sites110 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
pre term labor (PTL)
Sponsor
HAGAMEDICAL B.V.
Enrollment
110
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
October 11, 2019
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
HAGAMEDICAL B.V.

Eligibility Criteria

Inclusion Criteria

  • signs and symptoms or complaints suggestive of preterm labor (PTL)
  • gestational age between 20 and 37 weeks
  • \< 3 cm cervical dilatation
  • consenting to be part of tghe trial

Exclusion Criteria

  • Rupture of fetal membranes (ROM)
  • receiving tocolytic medication prior collection of cervicovaginal specimens
  • cervical dilatation \> 3 cm

Outcomes

Primary Outcomes

Not specified

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