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Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

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ClinicalTrials.gov Identifier: NCT01637610
Recruitment Status : Terminated (Lack of support with enrollment.)
First Posted : July 11, 2012
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Sabrina Stewart, University of Saskatchewan

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).

Condition or disease
Preterm Premature Rupture of Fetal Membranes

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.

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay
Study Start Date : September 2011
Primary Completion Date : August 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. accuracy of Amnisure vs conventional testing for PPROM [ Time Frame: up to 24 weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637610


Locations
Canada, Saskatchewan
Royal University Hopsital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan

Publications:
Responsible Party: Sabrina Stewart, Principal Investigator, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01637610     History of Changes
Other Study ID Numbers: 11-67
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: July 2012

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

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