About Us
“Dedicated to providing natural remedies”
Introuction
Natural Pain Relief
Twenty years ago a midwife had the idea of producing a specifically designed cooling Maternity Gel Pad for use in the vaginal, perineal and rectal regions. The overall aim was to promote a reduction in localised oedema, bruising and pain, comfortably and to fit in with women’s day-to-day activities. Following time consuming product development involving both women and midwives, a specially designed product is now available and its effectiveness is supported by research evidence. The research undertaken has already won several awards and has been highly commended for original research and clinical innovation.
Clinical effectiveness
The clinical effectiveness of a Cooling Gel Pad was initially evaluated in 1993/94 in a Maternity Unit in the North of England. A randomised controlled trial was undertaken involving women who had undergone an instrumental delivery aided by an episiotomy. A reduction in perineal oedema and pain was found to be significant at 48 hours and women’s opinions clearly demonstrated a preference for using the Gel Pad compared to standard regimes, Ice packs and Epifoam.
(Steen et al, 2000)
“In the United
Kingdom there are,
approximately, 750,000
live births per annum
and there is evidence
to suggest that 70% of
women will sustain
perineal injury during
childbirth.”
(Kettle & Johanson, 1997)
Following this initial randomised controlled trial, it was considered
important to involve a wide spectrum of views in the further design and
development of this product. A focus group was established involving hospital-based midwives, community midwives and women who were recovering from
either an episiotomy or second degree tear, their suggested recommendations
have been incorporated into the design of the new product.
In 1996, a survey of women’s opinions was carried out to select an acceptable
plastic covering in terms of comfort, texture, colour and flexibility. In 1997, a water-based and Florri Femé Pharmaceuticals Limited high thermal
capacity gel composition was investigated by cooling and warming rates in
laboratory experiments (Steen & Cooper, 1999). A risk assessment of the Gel
Pad components was conducted by the Material Safety Data Service on behalf
of the Control of Substances Hazardous to Health (COSHH) within a Trust in the North of England.. It was established that the gel pad had a low hazard rating and negligible exposure potential. A series of burst tests confirmed that the pad should be filled with approx. 80g of gel injected by means of compressed air and the curved edge sealed by high frequency ultrasonic welding.
Microbiological challenge tests where undertaken by the Infections Control Officer at the Trust hospital and the results demonstrated a negligible
recovery of organisms from the Gel Pad when it was washed with hot soapy water and dried thoroughly before reuse by the same woman. This final prototype of the Gel Pad has been evaluated in a large clinical trial during 1998/1999 and was supported by a NHS Executive research fellowship. (Steen, 1999) This trial involved women who had either a normal or an instrumental delivery and sustained perineal injury which required suturing. The trial explored women’s experiences of perineal trauma, wound healing, their opinions as to the need, acceptability and effectiveness of the cooling gel pad, both whilst they were in hospital and then in their own homes.