Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
All women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation.
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| 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 | |
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 May 19, 2013