CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of pr
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(2020) 20:698
STUDY PROTOCOL
Open Access
CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth risk Naomi Carlisle1*† , Agnieszka Glazewska-Hallin1*†, Lisa Story2, Jenny Carter1, Paul T. Seed1, Natalie Suff1, Lucie Giblin1, Jana Hutter2, Raffaele Napolitano3, Mary Rutherford2, Daniel C. Alexander4, Nigel Simpson5, Amrita Banerjee3, Anna L. David3,6 and Andrew H. Shennan1
Abstract Background: Full dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown. Methods: There are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG). CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth. CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section. CRAFT-IMG: Imaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche. (Continued on next page)
* Correspondence: [email protected]; [email protected] † Naomi Carlisle and Agnieszka Glazewska-Hallin are joint first authors. 1 Department of Women and Children’s Health, School of Life Course Sciences, King’s College London, 10th Floor, North Wing, St Thomas’ Hospital, Westminster Bridge Road, London SE1 7EH, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article ar
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