Women with a twin pregnancy are at a higher risk of going into early labour. The Arabin pessary is a small, cone-shaped device that is inserted through the vagina and surrounds the cervix, giving it support. This helps to keep the baby in the womb.
A large randomised trial has suggested that the pessary can reduce premature birth in women pregnant with one baby. Recently, a Dutch study has indicated that it may also work for twin pregnancies.
The STOPPIT-2 trial aims to find out for sure whether the Arabin pessary can help prevent premature birth of twins. Women with a twin pregnancy whose cervix is shorter than 35mm will be chosen at random to either receive the pessary, or standard treatment. The length of the cervix is important: if it gets too short, the risk of premature birth increases.
We plan to recruit over 2000 women to the screening phase (cervical length scanning) and randomise 500 women in the treatment phase of the study.
As of September 2018, 56 sites (mainly in the UK, but with some from Europe) are participating in the study. Over 1900 women have consented to cervical length scanning, and 448 have been randomised to the Arabin pessary or no treatment. We anticipate that recruitment will close in early 2019 and that results will be published in early 2020.
The pessary is cheap and easy to use, and if effective will have major health benefits across the world.
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