Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Saskatchewan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sabrina Stewart, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01637610
First received: June 28, 2012
Last updated: July 10, 2012
Last verified: July 2012

June 28, 2012
July 10, 2012
September 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01637610 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Preterm Premature Rupture of Fetal Membranes
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Canada
 
NCT01637610
11-67
No
Sabrina Stewart, University of Saskatchewan
University of Saskatchewan
Not Provided
Not Provided
University of Saskatchewan
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP