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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
Transvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia.
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGCRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
Time frame: Up to 42 weeks
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation
Time frame: Up to 42 weeks
CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.
We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.
Time frame: Up to 48 weeks
CRAFT-OBS: Number of participants with adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services)
Time frame: Up to 48 weeks
CRAFT-OBS: Number of participants who deliver <34 weeks gestation
Time frame: Up to 42 weeks
CRAFT-OBS: Gestation at delivery
The proportion of participants who delivery at each gestation of completed weeks
Time frame: Up to 42 weeks
CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate
Time frame: Up to 42 weeks
CRAFT-OBS: Any cervical length measurements taken antenatally
Time frame: Up to 42 weeks
CRAFT-OBS: Number of antenatal hospital appointments
Time frame: Up to 42 weeks
CRAFT-OBS: Number of hospital admissions
Time frame: Up to 42 weeks
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken
Time frame: Up to 42 weeks
CRAFT-OBS: Number of ultrasound indicated antenatal interventions
Time frame: Up to 42 weeks
CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks
Time frame: Up to 42 weeks
CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies
COPOP core outcomes
Time frame: Up to 48 weeks
CRAFT-RCT: Number of participants with an adverse perinatal outcome
Time frame: Up to 48 weeks
CRAFT-RCT: Gestation at delivery
Proportion of participants who deliver at each gestation of completed weeks
Time frame: Up to 42 weeks
CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)
Time frame: Up to 30 weeks
CRAFT-RCT: Time between intervention and delivery.
Time frame: Up to 42 weeks
CRAFT-RCT - Health costs at 28 days post-delivery.
Time frame: Up to 48 weeks
CRAFT-IMG: Evidence of cervical injury
Size of any cervical lesion and its location seen on MRI or ultrasound scans
Time frame: Up to 40 weeks
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