NCT02235181

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,228 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: Female
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

Detailed description

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.

Conditions

• Twin Pregnancy With Antenatal Problem

Interventions

Type	Name	Description
DEVICE	Arabin Cervical Pessary	The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-07-31
• Completion: 2019-10-31
• First posted: 2014-09-09
• Last updated: 2020-03-25

Locations

57 sites across 2 countries: Belgium, United Kingdom