Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01637610

Enrollment

Registered

2012-07-11

Start date

2011-09-30

Completion date

2014-01-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Premature Rupture of Fetal Membranes

Keywords

placental alpha microglobulin-1, AmniSure, preterm, rupture of fetal membranes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
accuracy of Amnisure vs conventional testing for PPROM	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.

Countries

Canada

Outcome results