Re: Amnisure for ruptured membranes

From: ainsron (ainsron@sbcglobal.net)
Thu Dec 1 16:13:24 2005


So if the new assay is compared to the standard procedures of identification of pooling, checking ferning, checking nitrazine and it is not 100% sensitive in comparison to those older methods and it's more expensive, why is it better?? It takes 5-10 minutes to read the Amnisure slide, I'm sure checking ferning on the microscope takes me a significantly lesser time under most circumstances.

Ronald E. Ainsworth, MD, FACOG

-----Original Message----- From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net] On Behalf Of RModugno@aol.com Sent: Thursday, December 01, 2005 1:12 PM To: Multiple recipients of list OB-GYN-L Subject: Amnisure for ruptured membranes

In a message dated 12/1/2005 3:53:20 PM Eastern Standard Time, ainsron@sbcglobal.net writes:

Any idea what the control methods used was? If it was the standard approach of slide for fern and nitrazine, why would I want to change what I am already doing if it is effective and cheaper?

Ronald E. Ainsworth, MD, FACOG

>From the article:

In a message dated 12/1/2005 3:53:20 PM Eastern Standard Time, ainsron@sbcglobal.net writes:

Any idea what the control methods used was? If it was the standard approach of slide for fern and nitrazine, why would I want to change what I am already doing if it is effective and cheaper?

Ronald E. Ainsworth, MD, FACOG

>From the article:Study Procedures
Participants who provided consent had both the standard clinical examination and the AmniSure test for PROM performed. The examinations were performed by different procedure-competent clinicians blinded to each other's results. The diagnosis of membrane rupture (control method) required the coinciding positive results of at least two of the following procedures: visual pooling of amniotic fluid, alkaline pH determination (Nitrazine test) of vaginal secretions, and microscopic evidence of ferning. A sterile speculum examination was performed. A sterile Dacron swab was used to collect fluid from the posterior vaginal fornix for the Nitrazine and fern testing. The presence or absence of pooling was visually assessed. Then the AmniSure placental alpha microglobulin- 1 (PAMG-1) assay was performed by the second examiner. A Dacron swab was passed along the distal vaginal sidewall. The swab was left in place for 20 to 30 seconds to ensure swab saturation. The swab was then agitated in the AmniSure diluent vial for 1 minute. The diluent-saturated swab was then applied to the AmniSure slide until one or two lines could be seen in the control and test windows. The slide indicated a negative or positive result within 5 to 10 minutes. (The latest version of AmniSure test simplifies this procedure by using a test strip that is dipped directly into the diluent vial, instead of a slide). After the patient delivered, the clinical record was reviewed to assess whether the patient had PROM or PPROM. The study data were collected, analyzed, and stored by study personnel in a fashion to ensure patient anonymity and confidentiality. The AmniSure PAMG-1 specimens were individually assessed for sensitivity, specificity, positive and negative predictive values, and false-positive and false-negative rates for PROM and PPROM. Discrepancies between the AmniSure and the control method were addressed by detailed review of the patient's clinical course by the local investigator.

Setting aside price for the moment, what do you classify as "effective?"

Disclaimer: Dr Modugno has no financial involvement with the makers of Amnisure.

Robert Modugno MD MBA FACOG

Marietta, GA

(Ain't this more exciting than homebirths or VBAC's?)





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