Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
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).
Preterm Premature Rupture of Fetal Membranes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay|
- accuracy of Amnisure vs conventional testing for PPROM [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]After delivery, the charts will be reviewed and information will be used to determine the final diagnosis of membrane status as ruptured or intact on initial presentation and will be used to evaluate the accuracy of the AmniSure test results.
|Study Start Date:||September 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
All women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637610
|Royal University Hopsital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|