Cerclage After Full Dilatation Caesarean Section

Not Applicable

• Conditions: Preterm Spontaneous Labor With Preterm Delivery; Preterm Birth; Preterm Premature Rupture of Membrane
• Interventions: Procedure: Insertion of transvaginal cerclage

• Registration Number: NCT04110704
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2019-10-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-04-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal cerclage	Insertion of transvaginal cerclage	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken	Up to 42 weeks
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-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	Size of any cervical lesion and its location seen on MRI or ultrasound scans
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	We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.
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: Number of antenatal hospital appointments	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: Gestation at delivery	Up to 42 weeks	Proportion of participants who deliver at each gestation of completed 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	The proportion of participants who delivery at each gestation of completed weeks

Trial Locations

Locations (1)

Guy's and St Thomas' Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom