SuPPoRT: Stitch,Progesterone or Pessary: a randomised controlled trial
Research type
Research Study
Full title
The prevention of pre-term birth in women who develop a short cervix. A multi-centre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal progesterone.
IRAS ID
138945
Contact name
Jackie Pullen
Contact email
Sponsor organisation
Kings College London
Eudract number
2015-000456-15
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Spontaneous preterm birth (sPTB) is a consequence of premature shortening
of the neck of uterus (cervix) and uterine contractions. Shortening of the cervix can be detected using transvaginal ultrasound measurements (internal ultrasound scan. Women found to have a short cervix are at higher risk of subsequent preterm birth. There are 12.9 million premature births annually worldwide and despite the magnitude of the problem, there is no established effective treatment for women once a high risk of preterm birth is ascertained. We currently have 3 potential preventative treatments; vaginal progesterone pessaries, cervical stitch and cervical arabin pessary. All three have been shown to reduce risk of preterm birth by similar degrees, but they have never been compared in a study. This study is a randomised clinical trial comparing the efficacy of these three treatments to prevent preterm birth in women who develop a short cervix.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0485
Date of REC Opinion
19 May 2015
REC opinion
Further Information Favourable Opinion