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
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 incre...
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| Format: | Article |
| Language: | English |
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BMC
2020-11-01
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| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12884-020-03375-z |
| _version_ | 1831798993788600320 |
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| author | Naomi Carlisle Agnieszka Glazewska-Hallin Lisa Story Jenny Carter Paul T. Seed Natalie Suff Lucie Giblin Jana Hutter Raffaele Napolitano Mary Rutherford Daniel C. Alexander Nigel Simpson Amrita Banerjee Anna L. David Andrew H. Shennan |
| author_facet | Naomi Carlisle Agnieszka Glazewska-Hallin Lisa Story Jenny Carter Paul T. Seed Natalie Suff Lucie Giblin Jana Hutter Raffaele Napolitano Mary Rutherford Daniel C. Alexander Nigel Simpson Amrita Banerjee Anna L. David Andrew H. Shennan |
| author_sort | Naomi Carlisle |
| collection | DOAJ |
| description | 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. Discussion The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies. Trial registration CRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ). |
| first_indexed | 2024-12-22T17:37:04Z |
| format | Article |
| id | doaj.art-ca5d34ab00b140fcb9dc486267160e8a |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-22T17:37:04Z |
| publishDate | 2020-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-ca5d34ab00b140fcb9dc486267160e8a2022-12-21T18:18:30ZengBMCBMC Pregnancy and Childbirth1471-23932020-11-0120111210.1186/s12884-020-03375-zCRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth riskNaomi Carlisle0Agnieszka Glazewska-Hallin1Lisa Story2Jenny Carter3Paul T. Seed4Natalie Suff5Lucie Giblin6Jana Hutter7Raffaele Napolitano8Mary Rutherford9Daniel C. Alexander10Nigel Simpson11Amrita Banerjee12Anna L. David13Andrew H. Shennan14Department of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonCentre for the Developing Brain, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonCentre for the Developing Brain, King’s College LondonElizabeth Garrett Anderson Institute for Women’s Health, University College LondonCentre for the Developing Brain, King’s College LondonDepartment of Computer Science, University College LondonDelivery Suite, C Floor, Clarendon Wing, The General Infirmary at LeedsElizabeth Garrett Anderson Institute for Women’s Health, University College LondonElizabeth Garrett Anderson Institute for Women’s Health, University College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonAbstract 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. Discussion The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies. Trial registration CRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ).http://link.springer.com/article/10.1186/s12884-020-03375-zCaesarean sectionFully dilatedFull dilatationLabour caesareanPreterm birthLate miscarriage |
| spellingShingle | Naomi Carlisle Agnieszka Glazewska-Hallin Lisa Story Jenny Carter Paul T. Seed Natalie Suff Lucie Giblin Jana Hutter Raffaele Napolitano Mary Rutherford Daniel C. Alexander Nigel Simpson Amrita Banerjee Anna L. David Andrew H. Shennan 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 BMC Pregnancy and Childbirth Caesarean section Fully dilated Full dilatation Labour caesarean Preterm birth Late miscarriage |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Caesarean section Fully dilated Full dilatation Labour caesarean Preterm birth Late miscarriage |
| url | http://link.springer.com/article/10.1186/s12884-020-03375-z |
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