Cerclage after full dilatation caesarean section
Research type
Research Study
Full title
CRAFT: Cerclarge after full dilatation caesarean section; an investigation into the role of previous in labour caesarean section in future preterm birth risk and potential management strategies
IRAS ID
261294
Contact name
Elizabeth Bruna
Contact email
Sponsor organisation
Vice President & Vice Principal (Research), King's College London
Duration of Study in the UK
2 years, 6 months, days
Research summary
Worldwide, there is a 9.6% rate of preterm birth before 37 weeks. The timing of delivery is directly related to infant risk. Extremely preterm deliveries under 28 weeks’ gestation carry greater risk for lung development, cerebral palsy, eye problems, as well as long-term difficulties and costs.
Risk factors increasing a woman’s risk of preterm birth include surgery to the neck of the womb (cervix), previous preterm birth and multiple pregnancy. A newly identified factor is previous caesarean delivery in the later stages of labour (particularly when fully dilated). We don’t know how significant this is, but it seems to increase the risk of preterm birth under 28 weeks, and late miscarriages (after 14 weeks pregnant). Because this is a recently recognised risk factor, we need to learn more, and how to reduce the risks.
Within the initial part, CRAFT-OBS, we want to learn the preterm birth risk depending on how late in labour the previous caesarean was. We will ask 2200 pregnant women who have had a caesarean in labour to take part. We will collect information about their previous births and follow up their current pregnancy.
We want to know if cerclage (a stitch placed around the cervix), a common treatment for women at risk of preterm birth with a short cervix, works as well for women with a previous caesarean. Therefore, CRAFT-RCT will compare 500 women with a cerclage with 500 women without. CRAFT-OBS and CRAFT-RCT will take place in at least 40 centres.
To identify cervical injuries, we will ask 60 women from with a previous full dilatation caesarean to participate in CRAFT-IMG. This will involve additional ultrasound scans and magnetic resonance imaging (MRI), and only take place at University College London Hospital and St Thomas' Hospital.
REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/1270
Date of REC Opinion
27 Aug 2019
REC opinion
Favourable Opinion