Twin Pregnancy With Antenatal Problem Clinical Trial
Official title:
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)
This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.
STOPPIT-2 is a multicentre open label randomised controlled trial of the Arabin pessary (CE
marked Device) versus Standard treatment in women with twin pregnancy. The study is in two
phases - a SCREENING phase, in which women with a short cervix (cervical length of ( less or
equal to 35mm) will be identified, and a TREATMENT phase, in which women with a short cervix
will be randomised to treatment with Arabin pessary or Standard treatment. Women will be seen
in the antenatal clinic setting.
An internal pilot phase will take place, with ten interviews being conducted with pregnant
women to explore the acceptability of proposed methods of recruitment, their information
requirements, their views of the consent and randomisation processes, and the delivery of the
intervention, including the screening component. The interviews will also explore their
understanding and expectations of trial participation. The findings of this pilot phase will
feed into the next phase of the trial and support the design of the interview guides for the
main nested qualitative study.
This pilot phase is separate from the main study. Later on we will ask both women and
healthcare professionals about their experiences of the study, via questionnaires and
face-to-face interviews.
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