NCT04110704UnknownNot Applicable
An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
Guy's and St Thomas' NHS Foundation Trust2 sites in 1 country1,000 target enrollmentStarted: October 2, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.
- •Singleton pregnancy.
- •Willing and able to give informed consent (with or without interpreter).
Exclusion Criteria
- •Under 16 years of age.
- •Inability to give informed consent.
- •Previous caesarean section carried out before labour.
- •Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study
- •Inclusion criteria:
- •Pregnant women up to 23+6 weeks gestation with a history of FDCS.
- •Short cervix (<=25mm) on transvaginal ultrasound scan.
- •Exclusion criteria:
- •Women with persistent fresh vaginal bleeding evident on speculum examination.
- •Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.
- •Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
- •Known significant congenital or structural or chromosomal fetal abnormality.
- •Suspected or proven rupture of the fetal membranes at the time of recruitment.
- •Inclusion criteria:
- •Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.
- •Exclusion criteria:
- •Contraindications to MRI, e.g. claustrophobia, BMI >40 kg/m2 (due to technical limitations of scanner) or a women with a non-MRI compatible metallic implant.
Outcomes
Primary Outcomes
CRAFT-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
Secondary Outcomes
- CRAFT-OBS: Number of hospital admissions(Up to 42 weeks)
- CRAFT-OBS: Any cervical length measurements taken antenatally(Up to 42 weeks)
- CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)(Up to 30 weeks)
- CRAFT-OBS: Number of ultrasound indicated antenatal interventions(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(Up to 42 weeks)
- CRAFT-OBS: Number of antenatal hospital appointments(Up to 42 weeks)
- CRAFT-RCT: Number of participants with an adverse perinatal outcome(Up to 48 weeks)
- CRAFT-RCT: Time between intervention and delivery.(Up to 42 weeks)
- CRAFT-IMG: Evidence of cervical injury(Up to 40 weeks)
- CRAFT-RCT - Health costs at 28 days post-delivery.(Up to 48 weeks)
- CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.(Up to 48 weeks)
- CRAFT-OBS: Number of participants who deliver <34 weeks gestation(Up to 42 weeks)
- CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate(Up to 42 weeks)
- CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken(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(Up to 48 weeks)
- CRAFT-RCT: Gestation at delivery(Up to 42 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)(Up to 48 weeks)
- CRAFT-OBS: Gestation at delivery(Up to 42 weeks)
Investigators
Study Sites (2)
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