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

    jackie.pullen@kcl.ac.uk

  • 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