Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

NCT01637610 | Terminated

• 1 other identifier: 11-67
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Premature Rupture of Fetal Membranes

Keywords

placental alpha microglobulin-1; AmniSure; preterm; rupture of fetal membranes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PPROM

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hopsital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (4)

• 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.

  PMID: 22280400 BACKGROUND

• Abdelazim IA, Makhlouf HH. Placental alpha microglobulin-1 (AmniSure((R)) 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.

  PMID: 22037683 BACKGROUND

• 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.

  PMID: 19350444 BACKGROUND

• 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. doi: 10.1055/s-2005-870896.

  PMID: 16118720 BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 11, 2012
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2012-07

Locations

CA (1)