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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01637610
• Other study ID #: 11-67
• Status: Terminated
• Phase: N/A
• First received: June 28, 2012
• Last updated: May 26, 2015
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2012
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Royal University Hopsital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Abdelazim IA, Makhlouf HH. Placental alpha microglobulin-1 (AmniSure(®) test) for detection of premature rupture of fetal membranes. Arch Gynecol Obstet. 2012 Apr;285(4):985-9. doi: 10.1007/s00404-011-2106-4. Epub 2011 Oct 30. — View Citation

Cousins LM, Smok DP, Lovett SM, Poeltler DM. AmniSure placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005 Aug;22(6):317-20. — View Citation

Lee SM, Lee J, Seong HS, Lee SE, Park JS, Romero R, Yoon BH. The clinical significance of a positive Amnisure test in women with term labor with intact membranes. J Matern Fetal Neonatal Med. 2009 Apr;22(4):305-10. doi: 10.1080/14767050902801694. — View Citation

Lee SM, Romero R, Park JW, Kim SM, Park CW, Korzeniewski SJ, Chaiworapongsa T, Yoon BH. The clinical significance of a positive Amnisure test in women with preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1690-8. doi: 10.3109/14767058.2012.657279. Epub 2012 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of Amnisure vs conventional testing for PPROM	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.	up to 24 weeks	No