NCT01637610

Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for combination of pooling, nitrazine and ferning) for the detection of Preterm Prelabour Rupture of Membranes (PROM).

Detailed description

Prior studies of AmniSure have included a heterogeneous population of women with preterm and term pregnancies.10-12 No study to date has specifically addressed and been powered to detect the efficacy of AmniSure in pregnancies between 16+0 and 36+6 weeks. The objective of the proposed research is to evaluate the usefulness of AmniSure PAMG-1 rapid immunoassay in the evaluation of preterm prelabour rupture of membranes (PPROM) compared to standard detection of PPROM with a speculum examination for combination of pooling, nitrazine and ferning.

Conditions

• Preterm Premature Rupture of Fetal Membranes

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2012-07-11
• Last updated: 2015-05-27

Locations

1 site across 1 country: Canada