Clinical trial NCT01637610: Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
Official title: Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preterm Premature Rupture of Fetal Membranes
Keywords: placental alpha microglobulin-1
AmniSure
preterm
rupture of fetal membranes
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 85
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: accuracy of Amnisure vs conventional testing for PPROM
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hopsital
state: Saskatchewan
Study officials:
References:
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.
citation: 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.
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.
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. doi: 10.1055/s-2005-870896.