Diony Young, Editor
BIRTH, Blackwell Science, Inc.
43 Oak St., Geneseo, NY 14454 USA
Phone or Fax: 716-243-0087
Hi Kerri-Anne,
I contacted the FDA about your question re Novatrix, and you should receive
a reply directly from Elisa Harvey, Exec. Director, FDA Obstetric and
Gynecologic Devices Panel. I am the consumer member on this panel. At this
point this device has not been approved for use in the United States.
Diony Young
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> From: Kerri-Anne <[log in to unmask]>
> To: [log in to unmask]
> Subject: Novatrix research
> Date: Sunday, July 18, 1999 5:38 AM
>
> At two local maternity units in Derby and Nottingham, UK, a trial has
> commenced very recently on a product from a company called Novatrix. The
> product is a belt that applies fundal pressure in the second stage of
labour
> and is used on women who have epidurals in-situ. The aim of its use is to
> increase vaginal delivery rates. One of the local units had a 70%
> primigravida epidural rate in one month!
>
> Apparently it has been used already in the USA and in some parts of the
UK
> without sound evidence of its safety or efficacy. Does anyone know of
this
> product? Does anyone have direct experience of women's and midwives
reaction
> to it and use of it? We are in the process of stimulating local debate
and
> really wish to hear of any information.
>
> Thank You
> Kerri-Anne Gifford,
> Commuinty Midwife
>
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