Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

Preterm Premature Rupture of Fetal Membranes Clinical Trial

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

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Preterm Premature Rupture of Fetal Membranes
• Rupture

• NCT number: NCT01637610
• Study type: Observational
• Source: University of Saskatchewan
• Status: Terminated
• Phase: N/A
• Start date: September 2011
• Completion date: January 2014