Cerclage After Full Dilatation Caesarean Section

Study Overview
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Brief Summary
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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.

Official Title
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An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies

Conditions
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Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery

Intervention / Treatment
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* Procedure: Insertion of transvaginal cerclage


Participation Criteria
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Eligibility Criteria
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CRAFT-OBS 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 CRAFT-RCT: 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. 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transvaginal cerclage<br> | Procedure: Insertion of transvaginal cerclage<br>* 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.<br>|
| No Intervention: Active monitoring<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) |  | Up to 48 weeks | 
| CRAFT-OBS: Number of participants who deliver <34 weeks gestation |  | Up to 42 weeks | 
| CRAFT-OBS: Gestation at delivery | The proportion of participants who delivery at each gestation of completed weeks | Up to 42 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 | COPOP core outcomes | Up to 48 weeks | 
| CRAFT-RCT: Number of participants with an adverse perinatal outcome |  | Up to 48 weeks | 
| CRAFT-RCT: Gestation at delivery | Proportion of participants who deliver at each gestation of completed weeks | 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-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 | Size of any cervical lesion and its location seen on MRI or ultrasound scans | Up to 40 weeks |