Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

Terminated

• Conditions: Preterm Premature Rupture of Fetal Membranes

• Registration Number: NCT01637610
• Lead Sponsor: University of Saskatchewan

Brief 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-28
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Primary Completion: 2013-08
• Study Completion: 2014-01
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

• women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation
• consent to enrollment

Exclusion Criteria

• vaginal bleeding
• active labor (cervical dilation > 2 cm or effacement > 80%)
• multiple pregnancy
• fetal anomalies
• placenta previa
• fluid loss per vagina > 7 days
• prior inclusion in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy of Amnisure vs conventional testing for PPROM	up to 24 weeks	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.

Trial Locations

Locations (1)

Royal University Hopsital; 🇨🇦 Saskatoon, Saskatchewan, Canada