Questionnaire Study of Arabin Pessary Experience v.1
Research type
Research Study
Full title
Treatment of High Risk Women with Arabin Pessary - Experience Questionnaire Study
IRAS ID
188308
Contact name
Angharad Care
Contact email
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
The Arabin pessary is a device that is currently used to treat pregnant women with a short cervix to reduce the risk of delivering their baby prematurely. This device is currently not used widely in the UK for this indication as vaginal progesterone and a cervical stitch are better established treatments. However, following a landmark study published in the Lancet in 2012 by Goya et al, Liverpool Women’s Hospital preterm birth clinic have been using the Arabin Pessary as a first line treatment ever since. Goya et al. reported the first multicenter RCT on pessary use in women screened by TVS and showed that the pessary reduced the rate of poor outcome and prolonged pregnancy compared to controls in women with a short CL (< 25 mm) between 18 and 22 weeks. Thereby 385 women were randomized to have a pessary (n = 192) or expectant management (n = 193). There were less births before 34 weeks of gestation in the pessary group (6% versus 27%; RR 0.24; CI 95% 0.13–0.43) and less births before 37 weeks (22% versus 59%; RR 0.36; CI 95% 0.27–0.49) and 28 weeks (2% versus 8%; RR 0.25; CI 95% 0.09–0.73) with a significant difference in composite poor neonatal outcome. However there is no published data on the experience of women’s pregnancies with the arabin pessary in situ. We propose to postal survey all women who have had treatment with an arabin pessary to determine their experience of pregnancy with an Arabin pessary in situ.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0710
Date of REC Opinion
27 Aug 2015
REC opinion
Favourable Opinion