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An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth \<34 weeks and \<37 weeks. CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.
Age
16 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Start Date
October 2, 2019
Primary Completion Date
April 1, 2022
Completion Date
October 1, 2022
Last Updated
July 28, 2021
1,000
ESTIMATED participants
Insertion of transvaginal cerclage
PROCEDURE
Lead Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05012072