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
  Purpose

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).


Condition
Preterm Premature Rupture of Fetal Membranes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637610

Locations
Canada, Saskatchewan
Royal University Hopsital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Alana M Geist, MD    306-381-3726    amg408@mail.usask.ca   
Contact: Sabrina Stewart, MD, FRCSC    306-652-4331    sabrinastewart@sasktel.net   
Principal Investigator: Sabrina Stewart, MD, FRCSC         
Sub-Investigator: Alana M Geist, MD         
Sub-Investigator: Angela Baerwald, PhD, CCRP         
Sponsors and Collaborators
University of Saskatchewan
  More Information

Publications:
Responsible Party: Sabrina Stewart, Principal Investigator, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01637610     History of Changes
Other Study ID Numbers: 11-67
Study First Received: June 28, 2012
Last Updated: July 10, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
placental alpha microglobulin-1
AmniSure
preterm
rupture of fetal membranes

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on July 31, 2014