CRAFT: Cerclage After Full Dilatation Caesarean Section
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transvaginal cerclage
|
Procedure: Insertion of transvaginal cerclage
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.
|
| No Intervention: Active monitoring
|
Outcome Measures
Primary Outcome Measures
- CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation [Up to 42 weeks]
- CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation [Up to 42 weeks]
Secondary Outcome Measures
- CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity. [Up to 48 weeks]
We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.
- 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: Number of participants who deliver <34 weeks gestation [Up to 42 weeks]
- CRAFT-OBS: Gestation at delivery [Up to 42 weeks]
The proportion of participants who delivery at each gestation of completed weeks
- CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate [Up to 42 weeks]
- CRAFT-OBS: Any cervical length measurements taken antenatally [Up to 42 weeks]
- CRAFT-OBS: Number of antenatal hospital appointments [Up to 42 weeks]
- CRAFT-OBS: Number of hospital admissions [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 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 participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies [Up to 48 weeks]
COPOP core outcomes
- CRAFT-RCT: Number of participants with an adverse perinatal outcome [Up to 48 weeks]
- CRAFT-RCT: Gestation at delivery [Up to 42 weeks]
Proportion of participants who deliver at each gestation of completed weeks
- CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging) [Up to 30 weeks]
- CRAFT-RCT: Time between intervention and delivery. [Up to 42 weeks]
- CRAFT-RCT - Health costs at 28 days post-delivery. [Up to 48 weeks]
- CRAFT-IMG: Evidence of cervical injury [Up to 40 weeks]
Size of any cervical lesion and its location seen on MRI or ultrasound scans
Eligibility Criteria
Criteria
CRAFT-OBS
Inclusion Criteria:
-
Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.
-
Singleton pregnancy.
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Willing and able to give informed consent (with or without interpreter).
Exclusion Criteria:
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Under 16 years of age.
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Inability to give informed consent.
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Previous caesarean section carried out before labour.
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Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study
CRAFT-RCT:
Inclusion criteria:
-
Pregnant women up to 23+6 weeks gestation with a history of FDCS.
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Short cervix (<=25mm) on transvaginal ultrasound scan.
Exclusion criteria:
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Women with persistent fresh vaginal bleeding evident on speculum examination.
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Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.
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Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
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Known significant congenital or structural or chromosomal fetal abnormality.
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Suspected or proven rupture of the fetal membranes at the time of recruitment.
CRAFT-IMG
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guy's and St Thomas' Hospital NHS Foundation Trust | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- King's College London
- University College, London
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 261294
- 42833